Clinical Pharmacology Resume Samples

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C Howell

Casper

Howell

61969 Kuhic Village

Dallas

+1 (555) 346 9031

61969 Kuhic Village

Dallas

Phone

p +1 (555) 346 9031

Experience Experience

Phoenix, AZ

Scientist, Clinical Pharmacology

Phoenix, AZ

Rodriguez-Nicolas

Phoenix, AZ

Scientist, Clinical Pharmacology

Responsible for managing bioanalytical reference materials and their qualification as bioanalytical standards
Manages internal GLP sample bank and contracted facilities for sample storage
Contributes to and manages GxP systems within Clinical Pharmacology, including acting as GLP study Archivist
Supports the design and preparation of clinical pharmacology development strategies, study protocols, clinical study reports and regulatory submissions and interactions
Opportunity to learn about and/or conduct toxicokinetic analyses, statistical programming, PK, PK/PD, popPK, nonclinical predictions or other activities related to pharmacometric analysis
Design and interpret PK/PD studies in support of molecules in clinical and nonclinical development
Analyze, Model, simulate and predict nonclinical and clinical data to drive decisions on dose and frequency of dosing

Boston, MA

Clinical Pharmacology Operations Research Associate

Boston, MA

Rau and Sons

Boston, MA

Clinical Pharmacology Operations Research Associate

Assists in the review of clinical monitoring reports, case report forms, safety report reviews, and correspondence related to monitoring visits
May generate or assist in critically evaluating proposals, contracts, and change orders from CROs and other vendors
Supports departmental initiatives and process improvements
Leads, assists, and/or monitors budget (accruals, forecasts, etc..) for clinical study (investigational sites and vendors)
Assists and/or participates in planning and conduct of investigator’s meetings, monitoring visits, Site Selection, Site Initiation, Observation, Interim and Close-out Visits
Collaborates with the cross-functional teams on selection and potentially management of clinical vendors
Leads and/or assists the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline

present

San Francisco, CA

Director, Clinical Pharmacology

San Francisco, CA

Weber, Prohaska and McLaughlin

present

San Francisco, CA

Director, Clinical Pharmacology

present

Demonstrated proficiency in performing PK and PD analysis using Phoenix WinNonlin, SPLUS and R
Represent Clinical Pharmacology on due diligence teams upon management request
Plan and execute the following
Collaborates with external consultants and CROs to perform population PK/PD analysis for ongoing projects
Supervise and/or mentor junior scientists and contribute to process improvement with an eye towards efficiency and consistency
Oversees scientific projects with external CROs and consultants to help develop validated bioanalytical methods for clinical studies
Provides clinical pharmacology expertise and support in the preparation of regulatory submissions (IB,IND,NDA)

Education Education

Bachelor’s Degree in Pharmaceutical Sciences

Howard University

Bachelor’s Degree in Pharmaceutical Sciences

Skills Skills

Excellent written and presentation skills
Identify program or study-specific issues. Generate potential solutions and work in a collaborative manner with team having excellent influencing skills
Understands and is able to apply appropriate regional and ICH regulatory guidelines in the design and analysis of Clinical Pharmacology programs
Able to assess, prioritize and manage a diverse, time-sensitive workload
Experience in authoring documents and reports including documents for submission to regulatory agencies
Working knowledge of pharmacokinetic program and analysis software (such as WinNonlin, NONMEM, R, ADAPT, Monolix, SIMCYP, etc.) along with PK modeling (Population PK, Disease Progression, Bayesian, Clinical Trial Simulations, etc.) and computer skills in scientific graphing
In-depth conceptual and technical/development expertise in the area of PK/PD or PBPK modeling and simulation

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Clinical Pharmacology Lead Resume Examples & Samples

30%-45% From Nomination for Development to Proof of Concept
30%-45%
Oversees or is responsible for the Phase 0, I and applicable IV studies which comprise either a program or study. Which includes, but is not limited to
O o the production of study related documents such as, but not limited to synopses/protocols and Informed Consent Documents
5%-20%

Clinical Pharmacology Medical Leader Resume Examples & Samples

100%
Responsible for study level protocol concept, design and oversight for clinical pharmacology studies across all phases and therapy areas
Provides expert Medical advice/leadership to the project teams for the development of Phase I - IV clinical pharmacology programs
Responsible for data analysis & interpretations and report writing
Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities
May be responsible for managing other Clinical Pharmacology physicians which would include interviewing and selection, setting objectives, assigning work, evaluating performance, reward and recognition, mentoring and coaching
As needed, may be responsible for Ophthalmology, CNS, GI, Hematology or other therapeutic area medical lead/medical monitor activities including Phase 1-4 program strategy and oversight, study design and NDA/BLA/MAA submission activities
MD, DO or equivalent is required
Minimum of 7 years of pharmaceutical industry drug development experience
Academic or pharmaceutical industry training and/or experience in clinical pharmacology

Senior Scientist Global Clinical Pharmacology Resume Examples & Samples

Help design Phase I Clinical Pharmacology studies
Perform literature searches and summarize the findings
Help design and execute PK, PK/PD modeling efforts to address the unique challenges pertinent to the project
Remain current with clinical and drug development information and methods in modeling and simulation by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and internalize key learnings back to Janssen
PhD or equivalent degree Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences
2+ years of relevant experience (including postdoctoral studies
Demonstrated understanding of model based drug development (MBDD), biopharmaceutics classification system (BCS), and biostatistics principles and tools (e.g., Gastroplus, Simcyp, Winnonlin, NONMEM) and demonstrated ability to apply these tools to enable rational and efficient drug development
Understanding of PK, PD, PK/PD, and Translational Medicine
Working knowledge of US, European, and Asian (including BRIC countries) regulatory requirements and guidelines
Ability to interpret PK and PKPD results and prepare presentations to illustrate findings accurately
Up to 5% travel will be required both domestic and international.Pharmacokinetics

Manager, Clinical Pharmacology Resume Examples & Samples

Under supervision this position serves as a clinical pharmacology and pharmacokinetic content expert and has a broad range of responsibilities that include developing and prioritizing strategic, tactical, and participation in multiple matrixed research and development teams
Contribute to the planning and implementation of bioequivalence, pharmacokinetic, pharmacodynamic, and clinical studies conducted by JJFC to ensure adherence to Good Clinical Practices, high quality of data, and the appropriateness of study designs to meet both domestic and international requirements. This is accomplished by having advanced knowledge in the statistical and medical interpretation of study results, the ability to understand state-of-the-art computer and mathematical techniques that are used to analyze these types of data, and broad knowledge of regulatory requirements for drug development
Contribute to the preparation of submission documents to global regulatory agencies (
Work with cross-functional partners to establish project success criteria, monitoring project progress, and communicating information to management
Ensuring that clinical pharmacology requirements of markets are understood and incorporated upfront from product concept development. This helps ensure that products are developed in a way that will facilitate prompt regulatory approvals with competitive advantages in the intended markets
Partner with marketing and R&D organization to develop robust and innovative claims supported with sound science
Work with global/ regional/ local colleagues to provide support required to ensure projects can be aggressively implemented with greatest commercial impact
Participate in assessing new product opportunities and identifying requirements for projects under consideration, including evaluation of clinical pharmacology and clinical efficacy data owned by external organizations with regard to potential product acquisitions or partnering in product development
Ability to provide pharmacokinetic and modeling support to project teams working on new formulations and new products, as well as those supporting marketed products
Evaluate appropriate preclinical pharmacokinetic testing requirements and study designs to support developmental projects
Summarizing, analyzing and interpreting pharmacokinetic results in preparation for submission to regulatory agencies
Supporting new business development by assessment of new business opportunities
Support initiatives to establish strategies and processes to meet global requirements
Ensure quality and compliance with applicable policies, standard operating procedures, and regulations
Respond to regulatory authorities on pharmacokinetic and pharmacodynamic related questions and issues
Ph.D. in Pharmacology or PharmD with a minimum of 4 years of industry experience is required
Previous experience in OTC drug development, pediatric pharmacokinetics, and experience interacting with regulatory authorities is desirable
This position requires knowledge in drug metabolism, pharmacokinetics, pharmacodynamics, and clinical trial design, and knowledge of regulatory requirements for drug development
Ability to balance and prioritize based on short timelines and intense work volume while adhering to quality compliance requirements
Must be highly motivated and organized with excellent oral, written communication and effective presentation skills
The ability to work in a matrix environment with global cross-functional teams is essential
This position may require up to 10% annual travel both domestic and international.Pharmacokinetics

Clinical Pharmacology & Pharmacometrics Manager Resume Examples & Samples

Providing oversight to all outsourced CPPM deliverables and ensures that all activities (in-house/outsourced) of CPPM are in compliance with CPPM strategy, regulatory and legal requirements and with company SOPs
Serve as a go to person for outsourcing within CPPM and contributes to the implementing and execution of the sourcing strategy
Work closely together with CPPM leaders, CPPM scientists and Pharmacometrics Leaders (PMLs) within CPPM
Leads business process improvement initiatives to contribute to the efficiency and effectiveness of the CPPM organization
Assist CPPM Therapeuthic Area (TA) Group leaders and Pharmacometrics Group Leaders with portfolio management meetings to plan and manage the portfolio from a resource, planning and budget perspective in alignment with Project Management Office (PMO) Lead and compound development strategy
Maintain functional planning systems and faciliate communications within CPPM and between/across functions, related to planning, submissions, cost estimation, outsourcing, quarterly FTE/OOPs review/validation for financial planning, by compound
Coordinate and track pre- and post- CPPM submission related activities/deliverables across all TAs for one or more products in late development and established products ensuring alignment with, and delivery on, the compound submission plan
Establish timelines to support compound development plans, consistent with overall business plan and CP strategy in collaboration with Project Management Office personnel, finance,Global Clinical Development Operations Organization (GCDO), CPPM Leader, Pharmacometrics Leaders and other business partners
Represent CPPM in cross-functional working groups per compound, and other non-trial-specific project-related meetings, to provide input regarding project or submission deliverables
This role requires a working knowledge of functional planning systems, tools and OOPs algorithms. Also requires experience with SharePoint, Excel, ARIBA, and an in-depth knowledge of contracting processes and systems, as well as compliance requirements for paying of vendors engaged in clinical research activities
Serve as the point person for all sourcing related activties within CPPM
Closely follow up on timely execution and finalization of contracts/work orders with External Service Provider (ESPs)/vendors, in partnership with Janssen R&D Procurement
Lead training initiatives for external service providers/vendors
Provide leadership and direction in developing, improving and implementing processes and tools to enhance the efficient implementation of outsourcing strategy
Provide External Service Provider (ESP) management
Collaborate with Bioresearch Quality & Compliance (BRQC) department in support of proces audits related to sourcing and vendor audits
Participate in initiatives and working groups related to Outsourcing
Coordinate OOPs estimates for business planning
Drive and facilitate process development and improvement initiatives (with ESPs). Conduct lessons learned
Carry out functional responsibilities in accordance to applicable SOPs and Regulatory requirements
Participate in optimization/maintenance of planning systems and tools
B.S., M.S., PharmD or equivalent with 4 years of industrial experience or CRO experience in areas of Drug Development is required
Project management experience is required
Experience managing cross-functional teams is required
Experience working with External Service Providers is preferred
Working knowledge of functional planning systems, tools and OOPs algorithms is preferred
Experience with SharePoint, Excel and ARIBA is preferred
Ability to communicate effectively, verbally and in writing, to individuals and groups at various levels in the organization is required
Understanding of scientific operations associated with clinical pharmacology, clinical drug development, and overall pharmaceutical R&D process is required
Knowledge of clinical pharmacology/pharmacokinetics concepts is preferred
Experience working with off shore teams across global time zones is required

Scientist Clinical Pharmacology & Pharmacometrics Resume Examples & Samples

Applies the understanding of (1) the impact of intra- and inter-subject variability in physiology and/or pathology, concomitant medication use, and biopharmaceutics, on pharmacokinetics (PK) and PK/pharmacodynamics (PD), and (2) requirements for the clinical pharmacology regulatory submission packages and submission processes
Assist CPPM and PM Leaders with the execution of scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates
Contribute to overall compound development via application of quantitative methods to integrate knowledge of PK, PD, patient characteristics, disease states, and drug-drug interactions to optimize dose selection, dosage regimens and study designs throughout drug development. With assistance from senior members, the PM Scientist will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles
Assist CPPM and PM Leaders with modeling and simulation activities in drug development programs. Perform and/or liaise for modeling and simulation analysis of preclinical-clinical data, translational PK/PD data, up to first-in-human (FIH) and if applicable beyond FIH (dose/exposure-response analyses to guide dose regimen from pre-proof of concept (POC), POC, dose-finding and Ph3 studies), including the support for regulatory and filing activities
Perform literature searches and summarize PKPD findings
Contribute to preparation of monographs, INDs and other documents as applicable to support PM analyses
Support CPPM and PM Leaders with ad-hoc PM analyses
Apply appropriate regulatory (e.g., FDA, EMEA, ICH, etc.) guidelines in the design of clinical development plans and studies
PhD, PharmD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences. Ph.D. degree or equivalent, with 0-3 years of relevant experience (including postdoctoral studies) or a MS or PharmD degree or equivalent, with 1-2 years of relevant experience
Understanding of overall process of drug development and the overall pharmaceutical R&D process
Has established a level of expertise and scientific reputation through publications and/or presentations
Drug development experience in one or multiple Therapeutic Areas and the ability to handle contributions to multiple clinical pharmacology programs, simultaneously
Demonstrated understanding of model based drug development (MBDD), physiologically based pharmacokinetics/pharmacodynamics (PBPKPD), and biostatistics principles and tools (e.g., Simcyp, NONMEM, or Winnonlin) and demonstrated ability to apply these tools to enable rational and efficient drug development
Knowledge on biologics PK/PD modeling would be great plus

Scientific Director, Clinical Pharmacology Resume Examples & Samples

Accountable for the clinical pharmacology development plan and analyses for assigned projects
Leads the effort in planning, execution, analysis and interpretation of clinical pharmacology and related studies from first in human through life cycle management
Provides strategic leadership and oversight for the clinical pharmacology development plan at all stages of drug development and at multi-disciplinary forums, both internally and externally
Develops modeling and simulation strategy for compounds in early development (up to PoC) and also undertakes hands-on modeling to address key development questions
Provides M&S support to projects across all development phases in collaboration with pharmacometricians, as necessary
Represents clinical pharmacology on Clinical Development Teams (CDT) for assigned projects and in the internal governance committees
Interacts with regulatory agencies and advisory committees as appropriate
Provides strategic direction to the writing and review of reports and integrated summaries submitted to the FDA or other regulatory authorities
Interacts with the wider matrix of stakeholders including the Full Development and Exploratory Development Teams as well as the preclinical and discovery groups
Participates in discussions and presentations to senior management
Responsible for department level budget and resources, whenever necessary
Participates in due diligence efforts to assess the value of assets
Overall, demonstrates evidence of strong leadership and managerial skills
PhD or PharmD in pharmacology or pharmacokinetics with at least 8 years of direct pharmaceutical industry experience in clinical pharmacology and/or pharmacometrics OR a MD with a clinical pharmacology research fellowship and at least 5 years of direct pharmaceutical industry experience in clinical pharmacology and/or pharmacometrics is required
Significant drug development knowledge is required
Clinical Pharmacology expertise in both biologics and small molecules is required
Direct knowledge/experience with pharmacometrics and model-based drug development is required
Experience on projects spanning the drug development continuum is preferred
Experience in interactions with worldwide regulatory agencies is required
Direct experience in preparing documents for regulatory submissions, responding to health authority questions related to clinical pharmacology and other related topics and overall familiarity with the regulatory process including IND, NDA/BLA, & MAA is required
Experience managing and mentoring junior-level scientists is preferred
Prior involvement & contribution in Advisory Committee meetings is preferred
Ability and willingness to travel regionally and globally (5-10% of time) is required
Ability and willingness to adjust work hours to facilitate global collaboration is requiredPharmacokinetics

Medical Sciences Mgr Clinical Pharmacology Resume Examples & Samples

At least 7 years of drug development experience with expertise in early clinical development
Experience in pharmacometrics
Solid understanding of GCP and Healthcare Compliance
Translational medicine background

Scientist, Clinical Pharmacology Resume Examples & Samples

Applies modelling and simulation to study design and data evaluation
Provides input to Clinical Development Plan and serves as subject matter expertise on clinical pharmacology and pharmacometrics
Designs and executes clinical pharmacology studies
Writes reports and regulatory documents
Supports publication strategy
Contributes to pharmacometrics infra-structure building
LI-SRC6
Proficiency in common pharmacometrics software, such as NONMEM, MONOLIX, WinBUGS, STAN, Matalab, R or S+
Motivated to apply modelling and similuation skills in drug develoment
Proven track record in drug development with specific
Familarity in relevant regulatory guidances
Strong writing, communication, and interpersonal skills
Computational Programming skills

Scientist, Clinical Pharmacology Resume Examples & Samples

With appropriate supervision is responsible for providing key components of the Clinical Development Plan (strategy/analysis through final reports) and for providing input and scientific opinion to project teams, line management, and governance bodies
With appropriate supervision leads preclinical and clinical pharmacology study efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, and reporting) within assigned programs to yield high value PK/PD/DM insight for future critical decisions. Analyzes results, interprets, and recommends action based on study results
Work with study and program teams to achieve program goals and provide deliverables in approved timeframes
With guidance, identifies program and study-specific issues. Generates potential solutions to issues and proposes those solutions to management and/or study teams
Develops and maintains strong knowledge of best regulatory practices, analytical technology and drug development precedent
With oversight provides insightful regulatory strategy for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents
Demonstrates a strong understanding of and experience in PK/PD principles and quantitative analysis
Employs continuous improvement in knowledge and practical understanding of Mechanistic/Systems Pharmacology, Modeling and Simulation, Clinical Pharmacology and application of this knowledge in the program team setting
Understands and is able to apply appropriate regulatory and ICH guidelines in the design of all studies
Can manage a diverse, time-sensitive workload
Possesses strong communication skills requiring minimal oversight in drafting grammatically correct written documents and making oral presentations
Has excellent organization and interpersonal skills

Director, Clinical Pharmacology Resume Examples & Samples

Plan and execute the following
PhD, or equivalent research training and background
3+ years of demonstrable and relevant clinical and/or bench research experience
Conversational familiarity with science outside of research specialty
Demonstrated ability to collaborate in multidisciplinary efforts
Ability to live in the Boston area
Working familiarity with inflammation, immunity, or ageing-related biology
Clinical subspecialty training
Pharmaceutical / biotech industry experience
Experience in human pharmacology or translational science

Medical Advisor, Clinical Pharmacology Resume Examples & Samples

Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring
Industry experience strongly preferred
Immunology expertise preferred
Clinical research or pharmaceutical medicine experience preferred
Knowledge of drug development process preferred
Fluent in English; both written and verbal communications
Interpersonal, organizational and negotiation skills
Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
Excellent teamwork skills
Willing to engage in domestic and international travel to the degree appropriate to support the business of the team

Senior Director, Clinical Pharmacology Resume Examples & Samples

Collaborate closely with clinical study teams during all Phases of clinical development (pre-IND through post-marketing, including life cycle management), provide guidance on clinical pharmacology issues and leverage expertise to influence decisions across functions and with corporate partners
Provide strategic and scientific guidance to Clinical Pharmacology team, anticipating program data needs and assisting with operational or regulatory issues
Leverage in-depth knowledge of pharmacokinetic and pharmacodynamic principles, including state-of-the-art quantitative and population-based modeling and simulation approaches to inform dose selection and guide dose optimization efforts
Lead multidisciplinary project teams through the successful integration of ADME, PK, and PK/PD information to build early clinical pharmacology programs including evaluation of drug-drug interactions, bioequivalence, safety pharmacology, food effects, etc. Guide study conceptualization, protocol development, and study start-up activities, including site initiation and investigator meetings
Build strong relationships that foster collaboration with colleagues in bioanalytics, biometrics, clinical development, drug metabolism and pharmacokinetics, toxicology and regulatory affairs for the conduct and interpretation of clinical studies
Review and prepare documents for regulatory submission including clinical development plans, Investigator’s Brochure and the Clinical Pharmacology section of INDs, CTAs and/or NDAs. Review/prepare responses to inquiries and represent Clinical Pharmacology group at any meetings with regulatory authorities
Critically evaluate internal data and scientific literature relevant to the mechanism of action of candidate drugs and provide expertise to define target engagement and early clinical evidence of efficacy in humans in collaboration with cross-functional teams
Contribute to Clinical Pharmacology publications and maintain active involvement in external scientific societies
Ph.D., M.D. or an equivalent degree in pharmaceutical or life sciences with 10+ years of experience in clinical drug development with expertise in pharmacokinetics, pharmacodynamics and clinical pharmacology
A proven record of scientific achievement, leadership, management and cross-functional collaboration
Data-driven, analytical and pragmatic approach to problem-solving and an ability to overcome challenges while working within project timelines
Extensive global regulatory experience in the clinical pharmacology aspects of FDA, EMA and ICH guidance documents
Ability to effectively interact with and influence senior leaders in discovery and clinical development teams

Associate Director, Clinical Pharmacology Resume Examples & Samples

Search, read and interpret scientific and medical literature for use in clinical pharmacology documents and for assisting clinical team decision making
Help develop pharmacokinetic components of nonclinical protocols
Prepare clinical pharmacology/pharmacokinetic portions of all relevant regulatory filings (IND, NDA, etc)
Perform pharmacokinetic data analysis/interpretation
Contribute to clinical study reports as requested by Medical Writing
5+ years of corporate, government or academic pharmaceutical development experience preferred
5+ years of experience in scientific research is required
Good working knowledge of Phoenix software
Outstanding teamwork, presentation, written and oral skills required
Travel required (up to 5 - 20% of time)

Systems Clinical Pharmacology & Pharmacometrics Resume Examples & Samples

Develop strategies for clinical pharmacology and pharmacometrics and execute analyses to advance drug candidates in an efficient and scientifically rigorous manner
Develop design and preparation of clinical pharmacology activities in clinical study protocols
Contribute to the clinical pharmacology sections of regulatory documents, including Investigator Brochures, EOP2 meetings, NDA/BLA/MAA. Develop, write and review clinical pharmacology regulatory submissions, and respond to queries from regulatory agencies
Perform modeling and simulation analyses related to pharmacokinetics and pharmacodynamics (PK/PD), and quantitative systems pharmacology, including non-compartmental analyses, nonlinear mixed-effect modeling
Collaborate with nonclinical and pharmaceutical development team members to define and generate in vitro and in vivo data to support clinical pharmacology studies

Associate Director, Clinical Pharmacology Resume Examples & Samples

Representation and/or leadership on strategic and operational cross-functional teams
Responsible for clinical pharmacology plans including drug-drug interaction, special population and safety studies
Create protocol concepts and guide protocol start-up including site initiations and investigator meetings
Oversee program progression including protocol conduct, data analyses, internal decision points and external regulatory interactions
Oversee and contribute to regulatory and safety documents
Collaborate with other functions to guide program deliverables
Provide expert input for internal review cycles
Responsible for clinical pharmacology summary documents
Guide PK analyses
Perform PK/PD or exploratory analyses or guide such analyses as appropriate
Work closely with colleges in Modeling & Simulation to ensure appropriate quantitative efforts to support the program
Maintain a high standard for good clinical practice, compliance and ethics
Pharm D/PhD within the area of Clinical Pharmacology or PK, with 5+ years industry or regulatory agency experience
Demonstrated experience with design and analysis of clinical pharmacology studies
Excellent understanding of and interest in PK/PD Modeling & Simulation, and use of clinical biomarkers for decision making
Effective at building alliances across functions, based on end-to-end drug development thinking and experience
Excellent interpersonal communication skills, able to drive global collaborations across a matrixed organization

Director, Clinical Pharmacology Resume Examples & Samples

Demonstrated proficiency in performing PK and PD analysis using Phoenix WinNonlin, SPLUS and R
Oversees scientific projects with external CROs and consultants to help develop validated bioanalytical methods for clinical studies
Collaborates with external consultants and CROs to perform population PK/PD analysis for ongoing projects
Provides clinical pharmacology expertise and support in the preparation of regulatory submissions (IB,IND,NDA)
Effectively represents Clinical Pharmacology on cross-functional study teams
Ph.D in Pharmacokinetics required
2-5 years of post-doctoral industry experience is required
Strong background in PK/PD analysis is required and the ability to conduct Pharmacology studies in population PK/PD analysis is highly desirable
A broad understanding of the principles of drug metabolism and bioanalysis is preferred
An understanding of Modeling and Simulation techniques to address exposure- response and exposure-safety, drug metabolism and principles of bioanalysis is highly desirable
Prior experience conducting data analysis and presentation of data and results to internal and external stakeholders
Ability to write high quality reports
Experience in working in cross-functional clinical study teams

Director, Clinical Pharmacology Resume Examples & Samples

Ability to work in a multi-disciplinary team setting
Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments
Evidence of strong management skills, as shown through management of multiple projects and staff members
Ability to ensure that appropriate personnel resources are applied to department projects based on priorities and relative complexity
Ability to manage intra- and interdepartmental schedules for large PK projects necessary for ANDA and NDA submissions
Demonstrated initiative and motivation
Excellent written and verbal communications skills. Strong communication skills, both written and verbal, with a clear understanding of scientific method
Good organizational skills with the ability to adapt and adjust to changing priorities
Positive attitude and the ability to work well with others
Ability to interpret and apply statistical techniques beyond standard textbook methodology
Knowledge of general clinical study designs, ability to modify or develop designs as needed for studies
Knowledge and understanding of absorption, distribution, metabolism and excretion of drug compounds
Ability to apply drug metabolism and pharmacokinetic concepts that result in logical and accurate interpretation of clinical study results
LI-KF1

Clinical Pharmacology Operations Lead Resume Examples & Samples

The incumbant will provide operational oversight and delivery of Phase 0, Phase I and applicable Phase IV studies that may or may not be part of a development program
In situations of a NCE with anticipated need of support from Clinical Pharmacology Operations, the Clinical Pharmacology Lead will manage and oversee the program in conjunction with the Global Clinical Operations Lead until the Proof of Concept is achieved
Post Proof of Concept, the Clinical Pharmacology Operations Lead supports the Global Clinical Operations Lead by overseeing the delivery of Clinical Pharmacology studies
30-40%
Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred but not required. Advanced degree preferred
Significant clinical research experience (8+ years) with evidence of increasing responsibility within a pharmceutical company or CRO

Associate Scientific Director of Quantitative Clinical Pharmacology Resume Examples & Samples

Consulting support for pharmacometric input and overall strategy upon request for preclinical projects upon request from Takeda preclinical research group
Ph.D. or equivalent higher degree +10 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience is preferred
PharmD +13 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience is preferred
Masters +15 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience is preferred
B.S. +20 years of pharmacometrics, clinical pharmacology, pharmacokinetic, or other relevant experience is preferredEducational degree in a relevant scientific area, e.g., Pharmacology, Pharmacokinetics, Pharmacodynamics, Drug Metabolism, Pharmacy, Bioengineering, Mathematics, etc
Significant drug development experience from a clinical pharmacology perspective is required
In depth, expert knowledge of pharmacometrics, pharmacokinetics and pharmacodynamics, including PK/PD data analysis and modelling techniques as well as interpretation of complex data and statistical analyses
Proficiency in R language is highly desirable
Strong knowledge of allied fields critical for drug development, such as drug metabolism, pharmacology, toxicology, bioanalytical chemistry, and pharmaceutical science
Must have scientific and technical expertise as evidenced by publications, patents, awards/honors and credibility at professional societies. Alternatively, must have evidence of successful utilization of scientific and technical principles in negotiation of project goals with internal management and/or regulatory agencies
Thorough understanding of drug development and global regulatory requirements
Excellent oral and written communication skills, including writing, reviewing, and editing scientific documents
Ability to be an effective member of multi-disciplinary project teams

Director, Clinical Pharmacology Resume Examples & Samples

Develop phase 1 clinical protocols as part of a clinical development team
Provide leadership in developing clinical pharmacology strategies for the life cycle management of Jazz products
Develop and execute pharmacokinetic components of nonclinical protocols
Prepare clinical pharmacology/pharmacokinetic and nonclinical DMPK portions of all relevant regulatory filings (IND, NDA, etc)
Work closely with other functional areas within the Research and Development Departments (clinical development, clinical operations, data management, biostatistics, non-clinical) to facilitate the execution of clinical trials
Prepare clinical pharmacology presentations
Assist with Phase 1 study conduct
Assess accuracy of clinical pharmacology data in clinical study reports and other documents
Represent the company at scientific and industry community meetings
10+ years of corporate, government or academic pharmaceutical development experience preferred
10+ years of experience in scientific research is required
Experience with pharmacokinetic and pharmacokinetic/pharmacodynamic data analysis
Excellent WORD, EXCEL and POWERPOINT skills
Collaborative and flexible in personal interactions at all levels of the company
Proven ability to work independently, proactively and effectively
Proven strategic planning, organizational and communication skills
PharmD, or PhD in Pharmacokinetics, Pharmaceutical Sciences or related discipline

Director Clinical Pharmacology, Non-oncology Resume Examples & Samples

Membership of the organization's core leadership in drug development
Membership of key senior management level decision-making committees, representing Clinical Pharmacology in strategic decisions
Development and recommendation of novel and state-of-the-art disease area specific clinical PK/PD study designs and clinical pharmacology strategies with the ultimate goal of personalizing treatment by the determination of clinical dose/route/regimen for molecules
Top level accountability for the strategy, experimental design, result interpretation, troubling shooting, and reporting of Clinical Pharmacology data and studies
Partner directly with stakeholders and project/program teams in Research, Early Development (pre-IND to EOPII) and Late development (Phase III through filing to post-market and new indications) to design and interpret the clinical pharmacology aspects of drug development, including decision analysis, regulatory acceptability and issue resolution
Understand the needs of and strongly influence senior management partners and stakeholders in Discovery, Early- and Late-stage clinical development functions for the success of the programs
Clearly identify and communicate potential project hurdles, suggests solutions and establishes priorities and contingency plans in collaboration with line function management, key partners in Early and Late Clinical and project team participants
Negotiate with Health Authorities (HA) worldwide regarding clinical pharmacology issues, scientific interpretation and acceptability of the sponsor's data
Assure support to all assigned projects is optimal in terms of quality, timing and cost; negotiates effectively as necessary. Monitor deliverables including timelines, objectives and budgets and ensure their alignment with development team goals
Ensures the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology (e.g. Investigator's Brochure, IND, CTD, IMPD, Health Authority briefing books)
Manage communications and relationship-building with internal and external stakeholders like Clinical Sciences, Biometrics, DMPK/PTPK, Biomarkers/assays, Regulatory functions in Clinical and CMC, Device development, Clinical Operations as well as external stakeholders like global Health Authorities
Maintain scientific and regulatory expertise in the fields of drug development clinical pharmacology and modeling and simulation
Play a major role in training, developing, and mentoring staff
Contribute to and provide leadership for the Department’s mission to advance the science of Clinical Pharmacology through publications, active involvement and leadership in external scientific societies and industry consortia, and collaborations with external partners

Cpm-clinical Pharmacology Resume Examples & Samples

Bachelor’s degree (scientific or health-related field preferred)
Minimum of five years clinical research or related clinical experience
Ability to lead decisively in the midst of ambiguity
Demonstrated ability to work effectively cross-culturally and in a virtual work environment across boundaries in order to develop strategies and plans, and deliver results through others
Demonstrated success in persuasion, influence, and negotiation skills in a matrix environment
Excellent oral and written communication skills; able to communicate clearly and with team members and leadership
Demonstrated knowledge and experience with project management tools and processes (e.g. management of integration, scope, time, cost, quality, human resources, communications, risk and procurement as defined by Project Management Body of Knowledge)
Strong problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent recurrence within the team
Experience working in the discipline of clinical pharmacology
Oncology, Autoimmune and/or device therapeutic area expertise
Global clinical research experience
Advanced degree in scientific or health-related field
Experience in working with a non-Lilly business partner (e.g., CRO, Alliance, Joint Venture)

Scientist Global Clinical Pharmacology Resume Examples & Samples

With guidance from senior members of the group, applies the understanding of (1) the impact of intra- and inter-subject variability in physiology and/or pathology, concomitant medication use, and biopharmaceutics, on pharmacokinetics (PK) and PK/pharmacodynamics (PD), and (2) requirements for the clinical pharmacology regulatory submission packages and submission processes
Assist CP and PM Leaders with the execution of scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates
Carries out functional responsibilities in accordance to applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles
Contribute to overall compound development via application of quantitative methods to integrate knowledge of PK, PD, patient characteristics, disease states, and drug-drug interactions to optimize dose selection, dosage regimens and study designs throughout drug development. With assistance from senior members, the TA Scientist GCP will translate quantitative knowledge into strategic opportunities with key stake holders to drive development along the model-based drug development principles
Assist CP and PM Leaders with modeling and simulation activities in drug development programs. Perform and/or liaise for modeling and simulation analysis of preclinical-clinical data, translational PK/PD data, up to first-in-human (FIH) and if applicable beyond FIH (dose/exposure-response analyses to guide dose regimen from pre-proof of concept (POC) and POC studies)
Help with design of Phase I Clinical Pharmacology studies
Manage operational elements of GCP studies with respective project CP Leaders
Contribute to preparation of monographs, INDs and other documents as applicable to support clinical studies
Support CP and PM Leaders with ad hoc analyses, not limited to non-compartmental analyses in support of Phase I studies
Work effectively in matrix environment, managing CP deliverables in accordance with timelines and overall project goals
Apply relevant technical trainings/learnings to daily responsibilities, with focus of opportunistic deliver of value/impact
MS, PharmD, PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences. Ph.D. degree or equivalent, with 0-1+ years of relevant experience (including postdoctoral studies)or a MS or PharmD degree or equivalent, with 3+ years of relevant experience performing progressively advanced duties
Has established a level of expertise and scientific reputation through publications and/or presentations is preferred
Has a background to influence the drug development experience in one or multiple Therapeutic Areas is preferred
Has an understanding of model based drug development (MBDD), biopharmaceutics classification system (BCS), and knowledge of biostatistics principles and tools (e.g., Gastroplus, Simcyp, Winnonlin, NONMEM) and demonstrated ability to apply these tools to enable rational and efficient drug development is required
Experience or working knowledge of US, European, and Asian (including BRIC countries) regulatory requirements and guidelines is preferred
Understanding of PK, PD, PK/PD, and Translational Medicine is required
Ability to interpret PK and PKPD results and prepare presentations to illustrate findings accurately is required
A basic and or working knowledge of disease processes and mechanisms, available treatment paradigms, and patient populations within assigned Therapeutic Area is preferred.Pharmacokinetics

Clinical Pharmacology Pharmacometrics Lead Resume Examples & Samples

Strong written and oral communication skills necessary to effectively communicate with external partners, including outsourcing vendors and KOLs, as well as with internal stakeholders
Entrepreneurial spirit, with ability to work in a dynamic, small team-oriented environment, across multiple assets and therapeutic areas
Independent Expert Scientific Leader who is able to make sound decisions based on the available information, working with a sense of urgency
Ph.D.in pharmacology, pharmaceutical sciences or another life science, or a PharmD with a clinical pharmacology research fellowship
A minimum of 7 years-experience gained through direct industry experience in Clinical Pharmacology and Pharmacometrics is required
The person that fills this role will have experience in the hands on modeling and application of quantitative clinical pharmacology including, pharmacometrics and other model-based approaches to guide drug development
Extensive knowledge of the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation and reporting is a prerequisite
Experience of working on the development of both small molecules and biologics is highly desirable
The successful applicant should have experience in providing strategic and scientific input on clinical pharmacology plans and the preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs)
Comfortable working in a fast-paced environment where speed is paramount
Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
Ability to recognize, articulate, and accept calculated risks to make informed decisions
Willingness and ability to effectively cooperate and partner with external vendors and BMS
She or he will have knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, pharmacodynamics, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, toxicology
1604320

Clinical Pharmacology Associate Resume Examples & Samples

Bachelor’s degree (preferably in a scientific or health-related field)
3 years clinical research/clinical trial experience
Demonstrated problem-solving abilities
Previous experience working in cross-functional teams or projects
First-hand experience in data management and medical writing activities and processes
Demonstrated ability to work effectively cross-culturally and in a virtual work environment
Strong knowledge of regulations and guidelines that apply to conduct of studies
Proficiency in Excel, MS Project, risk management tools, budget monitor & control tools

Clinical Pharmacology & Pharmacokinetics Leader Resume Examples & Samples

Design clinical pharmacology/PK programs to support the development, registration and commercialization of Shire’s products
A PharmD or PhD from an accredited college or university in clinical pharmacology, pharmaceutics, clinical pharmacokinetics, biostatistics or biopharmaceutics or closely related field and at least 7 years’ experience in the Pharmaceutical Industry working in clinical pharmacology, clinical pharmacokinetics or drug metabolism
10 - 15% domestic and/or international travel

Pre-clinical Pharmacology Project Leader Resume Examples & Samples

PhD
Post Doc ideally in biomedical sciences or Neuroscience
Expert knowledge of in vitro & in vivopharmacological models "hands on" experience in set up and conduct of test systems preferred
Strong interpersonal and people management skills
At least 5 years of Industry experience required
Experience in R&D therapeutic areas of Pain, CNS, Immune Disorders and Respiratory is highly desired

Associate Director Clinical Pharmacology Resume Examples & Samples

Develop clinical pharmacology, PK and PD strategy for Biosimilar development programs; contribute to the strategy for immunogenicity assessment
Contribute to elaborating strategies that may complement or substitute for clinical outcomes to streamline Biosimilar clinical programs
Provide expert Clinical Pharmacology counsel to the IPT (International Project Team), ICT (International Clinical Team), and other cross functional teams in the context of root cause analyses for specific issues
Ensure quality of the clinical pharmacology plans, project specifications, study protocols, reports, summaries and publications
Responsible for designing and analyzing the PK and PD components of clinical trials in all phases of development
Provide the PK/PD sections of clinical protocols, clinical study reports, Investigator’s Brochures, Health Authority Briefing Books, IND (Investigational New Drug) and IMPD (Investigational Medicinal Product Dossier) applications, CTD (Common Technical Document) summaries, and any other relevant. document for Health Authority submissions
Establish efficient collaboration with key partner functions within and outside. BCD (Biopharmaceuticals Clinical Development) (notably Biostatistics, Bioanalytics, Preclinical, Clinical Development, Regulatory Affairs, Technical Development and Analytical Characterization)
Ensure representation as needed for all health authority interactions
Develop and support external contacts (investigators, academic and regulatory community, partners in collaborations); maintain a contact with the broader Novartis Clinical Pharmacology network

Scientist, Clinical Pharmacology Resume Examples & Samples

Coordinates contracting of GLP bioanalytical studies related to Array-sponsored toxicology and clinical studies, including deliverables, timelines, legal and financial aspects of contracts. Works closely with clinical study teams and CROs
Scientific lead for outsourced method development, method validation, long term stability, sample analysis, data transfers and bioanalytical report generation with GLP labs. Monitors, audits and resolves technical challenges or issues as they arise at bioanalytical CROs
Responsible for managing bioanalytical reference materials and their qualification as bioanalytical standards
Manages internal GLP sample bank and contracted facilities for sample storage
Contributes to and manages GxP systems within Clinical Pharmacology, including acting as GLP study Archivist
Supports the design and preparation of clinical pharmacology development strategies, study protocols, clinical study reports and regulatory submissions and interactions
Opportunity to learn about and/or conduct toxicokinetic analyses, statistical programming, PK, PK/PD, popPK, nonclinical predictions or other activities related to pharmacometric analysis
BS (with 3+ years of industrial experience) or MS degree in the life sciences is required. Clinical pharmacology or statistical programming experience is a plus. Pharmaceutical company experience is strongly preferred
Familiarity with bioanalytical methodologies (particularly LC-MS/MS)
Basic knowledge of activities and requirements within the pharmaceutical industry, particularly as they relate to clinical pharmacology (e.g., regulatory guidances, GLP requirements, pharmacokinetic analysis, clinical pharmacology study designs)
Willingness and history of being able to work easily and productively both independently and with others in a team environment
Highly motivated to learn and contribute
Scientifically competent; demonstrates excellent analytical and problem solving skills
Travel: 1-3 out-of-state trips per year

Clinical Pharmacology Resume Examples & Samples

Conduct model based simulations to design studies that yield high value PK/PD/PGx information to aid future critical decisions
Advise and implement Quantitative Clinical Pharmacology aspects of regulatory strategy
Work in partnership with department Clinical Pharmacologist, Bioanalytics and Operations/Project Management peers and cross-functional teams
Present work at professional meetings and publish manuscripts in leading scientific journals
In-depth conceptual and technical/development expertise in the area of PK/PD or PBPK modeling and simulation
Working knowledge of pharmacokinetic program and analysis software (such as WinNonlin, NONMEM, R, ADAPT, Monolix, SIMCYP, etc.) along with PK modeling (Population PK, Disease Progression, Bayesian, Clinical Trial Simulations, etc.) and computer skills in scientific graphing
Understands and is able to apply appropriate regional and ICH regulatory guidelines in the design and analysis of Clinical Pharmacology programs
Experience in authoring documents and reports including documents for submission to regulatory agencies
Able to assess, prioritize and manage a diverse, time-sensitive workload
Identify program or study-specific issues. Generate potential solutions and work in a collaborative manner with team having excellent influencing skills
Excellent written and presentation skills

Drexel Co-op-janssen R&D Biologics Clinical Pharmacology Resume Examples & Samples

To develop and validate immunological methods for supporting nonclinical and clinical PK studies under GLP guidelines
Assay trouble shooting, development of new technology platforms (SPARCL, Singulex, etc.) and assay automation
A couple of projects available to work on are
Multiplexing hybrid LCMS/MS PK Assays for simultaneous drug monitoring in noncling/clinical to support pre-/post-NME efforts
PK assay workflow modifications for improved efficiency and sensitivity using assay plates with covalent binding surfaces
The ideal candidate should be enrolled in BS/MS program in life sciences or a related scientific discipline with some relevant laboratory experience
The individual must be motivated with a strong desire and interest in learning laboratory and scientific techniques in the Pharmaceutical R&D environment
The candidate must be able to work with human and animal blood, body fluids and tissues
The successful candidate must have excellent: computer, record keeping, writing and communication skills

Consultant CPM Clinical Pharmacology Resume Examples & Samples

Bachelor’s degree in a scientific or health-related field
Minimum of five years clinical research or relevant experience with a strong knowledge of regulations and guidelines that apply to the conduct of clinical trials from discovery to commercialization
Strong leadership and networking skills
Strong self-management and organizational skills
Strong knowledge of regulations and guidelines that apply to conduct of clinical trials
Understanding of clinical drug development processes and the interdependencies of various tasks that require coordination among teams, functional groups, and regions
Strong computer skills; skilled at using Word, Excel, PowerPoint, and Microsoft Project; capable of maintaining the appropriate project documentation and applying CCPM methodology

Clinical Pharmacology Pharmacometrics Lead Resume Examples & Samples

This scientific leader will apply their Clinical Pharmacology and Drug Development expertise to the development of multiple small molecule and biologic assets in Cardiovascular, Fibrosis, Immunology and Genetically Defined Diseases that help patients prevail over serious diseases
Will weigh competing priorities across assets, make decisions and provide clear direction to internal and external partners and team members
This person will play a key role in the design and interpretation of healthy subject as well as patient studies conducted in early, full and life cycle stages of development
Will provide Pharmacometrics strategic leadership to early and late stage assets. The candidate will provide critical input on the design and execution of Clinical Pharmacology and modeling and simulation plans, and be able to create a robust human Clinical Pharmacology profile by integrating results from a broad spectrum of non-clinical, clinical and model-based assessments
Effectively communicate with outsourcing partners on the clinical pharmacology and pharmacometrics strategy for each compound, and ensure execution
Will serve as the Clinical Pharmacology and Pharmacometrics subject matter expert on cross functional asset teams and provide his/her functional expertise during health authority interactions and regulatory submissions
The Scientist will sit on the organizational Clinical Pharmacology & Pharmacometrics Senior Leadership Team

Data Manager, Clinical Pharmacology Resume Examples & Samples

Preparation, conduct, and close of data management activities
Bachelor’s or higher degree in a relevant subject
2+ years’ work experience within the clinical data management function of a pharmaceutical, biotech or CRO organization
Familiarity will all relevant guidelines and aspects of clinical data management
Experience with programming languages (SAS, R)
Experience in working with and managing external service providers and CROs
Experience with clinical trial databases, CDMS systems, electronic data capture and CDISC data standards
Knowledge of ICH GCP and a strong interest in clinical research
Ability to work unsupervised, taking responsibility for own actions
Proactive and self-motivated personality with profound problem solving skills
Flexible but persistent and result-oriented
Ability to work precisely according to procedures, rules and regulations
Fluency in English (written and spoken)

Scientist, Clinical Pharmacology Resume Examples & Samples

Design and interpret PK/PD studies in support of molecules in clinical and nonclinical development
Analyze, Model, simulate and predict nonclinical and clinical data to drive decisions on dose and frequency of dosing
Perform population PK and PK/PD analyses on drug candidates as they progress through clinical development
Interact with pharmacologists, toxicologists, medical directors and regulatory affairs personnel within BioMarin for the timely completion of clinical and nonclinical studies and regulatory filings
Represent Clinical Pharmacology on multi-disciplinary study teams with a potential to represent the function on project teams
Write protocol sections, analysis plans, reports, sections to INDs, NDAs, etc

Quantitative Clinical Pharmacology Resume Examples & Samples

Ideally Pharm D or PhD
Demonstrated experience of participating and contributing to the development and execution of the clinical plan, with specific input and expertise in the clinical pharmacology components, including regulatory aspects
A strong understanding of pharmacodynamics and translational methods, experimental medicine tools, regulatory requirements, population PK-PD modelling and simulation

Senior Director Clinical Pharmacology LCM Resume Examples & Samples

PhD or MD with prior experience in clinical pharmacology
Prior experience with regulatory submissions and regulatory interactions
Working knowledge and understanding of quantitative methods (modelling and simulation)
Project experience working in a matrix environment
Development of quantitative clinical pharmacology approaches into evidence generation plans, with the objective of optimising the therapeutic use of existing medicines and identifying opportunities for secondary indications and line extension
Addressing regulatory queries and issues arising during life-cycle management of approved products
Coordination of and contribution to the review of regulatory and clinical queries from local operating companies across the globe
Evaluation of quantitative (pharmacometric) methods to support evidence synthesis and assessment of benefit-risk ratio in clinical practice and real life scenarios
Support the design of Phase III and IV trials to assess the intrinsic and extrinsic impact of sources of variability on pharmacokinetics, pharmacodynamics, efficacy and safety
Assessment of the dose rationale for especial populations, including paediatric and elderly patients
Justification of the rationale for clinical pharmacology plans and results through interaction with internal/external stakeholders
Learning and exploring the value of emerging sciences and methodologies through effective external collaboration

Clinical Pharmacology Manager Resume Examples & Samples

Provide operational oversight and delivery of Phase 0, Phase I, and applicable Phase IV studies that may or may not be part of a development program
Play a vital role in clinical trials, by supporting applicable Global Clinical Operations Lead and ensuring that the study (ies) are being conducted in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH)
Manage, facilitate, and/or participate independently or with minimal managerial oversight in all aspects of a Clinical Pharmacology study (ies), or other studies as necessary. This may include but is not limited to

Director, Clinical Pharmacology Resume Examples & Samples

Clinical Pharmacology leader on multiple project teams across modalities and indications
Interact with cross functional matrix team personnel within BioMarin and contribute to strategic and scientific planning and execution
Accountable for developing and implementing translational strategy with a focus on clinical dose, route and regimen selection
Analyze and interpret PK/PD data from nonclinical and clinical studies using appropriate quantitative methodologies
Supervise and/or mentor junior scientists and contribute to process improvement with an eye towards efficiency and consistency
Interact with external collaborators, key opinion leaders and vendors as appropriate
As CP leader, author sections of regulatory documents and represent the function at regulatory interactions as appropriate
Lead cross functional process initiatives to improve consistency in deliverables and interactions with internal partners
Represent Clinical Pharmacology on due diligence teams upon management request
Required: At least 8 years of industry experience in Clinical Pharmacology working in a matrix environment on drug development teams
Required: Strong PK/PD skills, extensive knowledge of pharmacokinetic concepts, DMPK and Pharmacometrics (e.g., WinNonlin and /or NONMEM)
Required: Excellent writing and verbal communication skills and experience in regulatory interactions
Required: Clinical Pharmacology leadership experience representing the function in both strategic and scientific team settings
Preferred: 10+ years of experience in Clinical Pharmacology across the drug development paradigm
Preferred: Experience with PBPK modeling, pediatric extrapolation and pediatric drug development
Preferred: Clinical Pharmacology experience with biologics and small molecules
Preferred: Cross-functional leadership experience and supervisory experience

Quantitative Clinical Pharmacology Resume Examples & Samples

Act as a QCP/PK-PD lead on assigned CRST and program/project teams, delivering Quantitative Clinical Pharmacology Strategic planning. In particular, ensure that clear strategic QCP/PK-PD direction and input is provided to study level plans, designs, dose selections, PK/PD measures, strategy, and where appropriate operational expertise. Responsible for design, analysis, interpretation and reporting of human pharmacology results and PK-PD results from non-human pharmacology studies. Developing/managing clinical pharmacology/M&S -related aspects of clinical trial/program budgets
Participate in implementing Model Based Drug Development using quantitative approaches to address complex questions arising during drug development. In particular, integrating PK-PD knowledge on an ongoing project basis. Accountable and responsible for assigned protocol synopsis and study report content
As appropriate, being the overall early lead for the assigned project
Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD data are generated and analyzed including population PK, PK-PD modeling and simulation, meta-analysis etc., to support the project progression
Providing recommendations for clinical doses and dosing algorithms to the clinical and Development teams and, for the project of competence, leading the quantitative clinical pharmacology contributions to all regulatory documents, leads and contributes to the writing and reviewing responses to regulatory queries
May provide quantitative clinical pharmacology/pk-pd expertise to discovery and due diligence activities
Expanding and maintaining key networks of external thought/opinion/academic leaders, as well as alliances with partners from the pharmaceutical industry, ensuring publication of key clinical pharmacology studies in international, peer reviewed journals, and presentations at international scientific meetings of relevance
Knowledge of Clinical Pharmacology and the application of Modeling & Simulation
Able to understand clinical effects, pharmacological, physiological and biochemical understanding
Knowledge of basic pharmacology in vivo/in vitro models
Able to understand/Interpret safety/pharmacology/toxicology data
Experience in the assigned therapeutic area and with surrogate marker identification and application
Experience in managing/delivering PK/PD modeling activities
Experience in managing/delivering PBPK, population PK and IVIVE
Understanding of mechanism-based drug interactions/In vivo/in vitro models
General knowledge of Biopharmaceutics/Biostatistics/Pharmacogenomics
Sufficient Knowledge of phases of Drug development
Able to communicate quantitative clinical pharmacology PK/PD core activities at a project and clinical team level in a manner that promotes productive relationships
Ability effectively contribute to interdisciplinary team meetings and, able to effectively leading sub-teams (e.g. QCP) motivating others in matrix/departmental environment
Able to represent function and UCB at regulatory meetings
Understand drug development bridging strategies
Ability to anticipate program needs and problem-solve, sharing critical data within the team and the line and proactively proposing solutions,
Working in a matrix team based environment being the initiator of the assigned part of development plans and studies
Scientific expertize recognized internally and externally

IT Business Partner for Clinical Pharmacology & Pharmacometrics Resume Examples & Samples

Accountable for positioning CP&P for success in the digital era: lead and accelerate CP&P’s digitization through technology innovation, ensure that CP&P’s information capabilities and operations are reliable, accessible and secure, and enable CP&P’s transformation to become competitively differentiated in a rapidly-changing scientific landscape
Responsible for identifying digital capabilities that have the greatest impact on R&D CP&P, set the right expectations, and ensure that IT delivery resources are appropriately engaged to fulfill the business outcomes. Develops strategic roadmap describing a vision for the long-term development of CP&P IT digital capabilities, and translates those roadmaps into actionable capability projects with clearly articulated business cases
Responsible for developing strategic and collaborative partnerships with senior CP&P leaders. Trusted partner to CP&P leadership, and works closely with them to ensure that IT fully supports CP&P’s scientific mission
Line management of CP&P IT team including one FTE plus 5 consultants. This team has strong expertise in IT and informatics in the domains of clinical pharmacology, and pharmacometric modelling. Mentors and develops staff to achieve and exceed performance, and to sustain talent pipeline for the future
Matrix leadership of IT resources in other IT functions: responsible for ensuring that all IT functions are successful in their delivery of services to CP&P. Key matrix IT partner functions include platform architecture, software engineering, application support & maintenance, program management, information & data management, collaboration services, infrastructure services
Strong domain expertise in the application of IT in CP&P, including a broad understanding of typical CP&P scientific processes and how they are supported by IT tools and systems
Ability to lead the analysis of complex and ambiguous scientific business needs, and integrate those into compelling and actionable strategic plans, and a track record of delivering high-value capability projects in a translational research environment
Good knowledge of high-performance computing technologies including cluster and cloud-based computing, non-linear mathematical modeling especially as applied to translational bioinformatics
Knowledge of CP&P technologies, typical data types, and digital capabilities required to support CP&P workflows
Seasoned line and matrix management skills, with a particular emphasis on energizing and developing experienced technical specialists spread across multiple sites
Excellent collaboration and communication skills, with the confidence to build strong partnerships with senior scientists and physicians and also become trusted advisers to senior leaders
Working knowledge of agile software-development lifecycle methodologies
Working knowledge of GxP regulations and delivery of IT projects in a GxP environment
A broad technical background particularly hands-on Unix and Oracle experience
Demonstrated ability to create and support a dynamic culture of innovation and continuous improvement in line reports and in the matrix
Potential to develop into an internally and externally recognized thought-leader in the field of CP&P IT
PhD/ MS in Life Sciences, Engineering, Information Technology or a related discipline
7+ years’ experience in leadership roles in IT for biopharma R&D, bioinformatics, biostatistics, and/or translational research in academia

Clinical Pharmacology Resume Examples & Samples

Advanced training with a degree such as PhD, PharmD and MD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development
Sound understanding of pharmacokinetic and pharmacodynamic principles and commonly applied models
Knowledge of, or ability to quickly learn, the mechanism, endpoints, progression and treatments of relevant diseases
Working knowledge of common tools for quantitative clinical pharmacology such as NONMEM, Monolix, SAS, R and MATLAB
Experience in using pharmacokinetic and pharmacodynamic modelling to design trials or to analyse results
Ability to communicate clearly and succinctly with the audience in mind, both orally and in writing
Ability to form effective collaboration while taking personal accountability for timely delivery of quantitative clinical pharmacology results
Sound judgement, analytical mindset and problem-solving skills
Ability to effectively multi-task and deliver results on time
Experience in designing clinical pharmacology plans with a model-based mindset
Experience in designing, analysing and reporting clinical studies with a model-based approach
Familiarity with regulatory submission documents such as CTAs, INDs, NDAs/BLAs and MAAs

Clinical Pharmacology Intern Resume Examples & Samples

Collaborate with external network in the field of clinical pharmacology, modeling & simulation (e.g. academia, consortia & CROs) and keep up to date with emerging literature and science in modeling approaches
Understanding of drug development and pharmaceutical industrial is highly desired
Publication record with clinical pharmacology journals or modeling is a plus

Scientist, Clinical Pharmacology Resume Examples & Samples

0 to 2 years of industry experience (Scientist 1) with a strong background in Pharmacokinetics and Pharmacodynamics. Post-doctoral or some industry experience is preferred
Strong training in PK/PD analyses with a preference for population based modeling and simulation
Extensive hands-on experience with non-compartmental and compartmental PK/PD analysis using WinNonlin and NONMEM software
Excellent writing and verbal communication skills
Ability to work in a matrix environment and with different leadership styles

Manager Non-clinical Pharmacology Global Regulatory Affairs Resume Examples & Samples

Minimum Level of Education: M.Sc., DVM or equivalent
Area of Specialisation: Pharmacology, immunology, or biological sciences
6+ years in pharmaceutical industry or research organization, with 3y+ experience in Regulatory Affairs and non-clinical writing (pharmacology, immunology)
Good knowledge and expertise in pharmacology and immunology including: guidelines, requirements and regulations; methodologies; results interpretation and presentation
Scientific and regulatory knowledge required, including
Scientific: toxicology, biology, infectious diseases, biochemistry, immunology,
Regulatory: guidelines, legislation, registration procedures and regulatory authorities
General knowledge of GSK Vaccines products/techniques
Experience in scientific writing
Experience of Drug Discovery and Development, non-clinical writing – experience of GSK Vaccine Development would be an asset
Effective time management, ability to clearly identify priorities and manage multiple tasks
Excellent written and oral communication skills,
Ability to strategize, problem solve and influence
Expertise in vaccines development (non-clinical immunogenicity vaccine efficacy animal models, preclinical readouts) or biopharmaceuticals would be an asset
Knowledge of nonclinical safety assessment (toxicology) methods and guidelines would be an asset
Coordinate the preparation, review and management of the nonclinical pharmacology files (CTD m.2.4, m2.6 and m4) with the appropriate contributing disciplines and Project GRA Teams for the GSK Vaccines product development portfolio
Ensure Regulatory affairs follow-up of file submissions, Q&A, contacts etc. through active and efficient interactions with both contributing disciplines and Project GRA Teams
Responsible for ensuring the quality/comprehensiveness of data/reports to be used in regulatory documents
Proactively determine, together with internal teams, the non-clinical pharmacology file content and necessary quality of the data to be included in the regulatory documents, files and answers to questions from regulatory authorities
Ensure the documents are checked for quality & accuracy and that they are compliant with applicable Regulatory guidance/Legislation
Ensure coherence across and with previous pharmacology submissions
Provide pharmacology expert advice in all matters where this is required to support GSK Vaccines product portfolio
In partnership with the Senior Manager, non-clinical pharmacology, develop and maintain efficient and effective interactions with other GSK Vaccines departments to ensure harmonization and high quality of documentation provided to RA for submission to internal GSK boards and external regulatory bodies
Provide input to R&D through formal (eg PRIMARA advisory body) and informal (eg; ad-hoc meetings) interactions with R&D to ensure necessary quality and content of preclinical documentation provided to RA
Ensure harmonization of RA documentation provided to Regulatory authorities
Ensure adequate and efficient interactions with internal and external regulatory experts and with regulatory authorities to optimize RA strategy, regulatory documents, or file contents towards high quality documents and on-time approvals of GSK vaccines

Senior Fellow, Clinical Pharmacology Resume Examples & Samples

6 - 10 years of relevant post doctoral, academic, industry or government experience
Expert knowledge of related disciplines (e.g. DMPK, toxicology, regulatory) and the drug development process
Demonstrated experienceusing in silico analysis tools (e.g. WinNonlin, SAS, NonMEM, Trial Simulator, GastroPlus, SymCyp)
Demonstrated experience and ability to work successfully as part of cross functional team in a highly dynamic, matrixed, project team environment
Strong organizational and project skills
Expert critical thinking and problem solving skills including publications / presentations
Strong influencing and negotiating skills
Coaching, mentoring, and people management skills

Scientist, Clinical Pharmacology Resume Examples & Samples

Perform population PK/ PKPD analyses and report writing in support of regulatory submissions
Support of “Big Impact” product development projects in all stages of drug development using mechanism-based modelling & simulation methodologies (systems biology, disease progression
Modelling, landscape analysis, etc..) using data acquired at various development stages or using literate searched data
Perform exploratory modelling projects asking quick turnaround to support critical business decisions
Beyond and as a result of the above, support and input is given into
Development and review of ClinPharm Population PK study design sections in clinical trial protocols and assistance is provided to the ClinPharm Leader in the defence of the synopsis and protocols at Synopsis Review Committee (SRC) and Protocol Review Committee (PRC) meetings
Assists the ClinPharm Leader in the overall ClinPharm development strategy, the design of specific ClinPharm studies including the design of modelling and simulation-based assessments within clinical Phase 2/3 studies
Collaboration, when applicable, with the ClinPharm Leader and ClinPharm Program Manager in the evaluation of Contract Research Organization (CRO) capabilities. Actively participates in the review and monitoring of outsourced Population PK/PD-related activities
Working in close collaboration with the Biostatistics and Programming group
Development/writing/reviewing (including QC) ClinPharm sections of various internal documents and presentations
Establish scientific credibility inside and outside the company (e.g., abstracts, posters, publication in peer reviewed journal, podium presentation at conferences)
Initiate and contribute to the development of new scientific methodologies, while ensuring high quality standards
Leads by example, is a mentor and scientific coach of Associate scientists, Sr. associate scientists and Scientists
Demonstrates in-depth knowledge/expertise in Clinical Pharmacology and/or associated disciplines by developing scientific projects and effectively applies state-of-the-art scientific knowledge to these projects
Supports installation and validation of new and existing software used by Pharmacometrics
Trains new hires and in-house contractors on PHARMACOMETRICS - related processes
Carries out functional responsibilities in accordance with applicable SOPs and Regulatory requirements
Assists in process improvement initiatives and SOP development
Ph.D. Degree or equivalent, minimum 1 years of relevant experience; M.S. Degree, PharmD, or equivalent and at least 6 years of experience
Fluent in written and spoken English
Excellent hands-on knowledge of data handling packages (SPLUS / R / SAS)
Excellent data-handling skills and working knowledge of database structures
Excellent Hands-on knowledge of PK & PD Nonlinear Mixed effect modeling software packages
A fundamental understanding of clinical drug development
A fundamental understanding of ICH and other relevant regulatory guidelines and regulations
Experience in 1 or more therapeutic areas
Has begun to establish a level of expertise or scientific reputation though publications and presentations at external meetings9031170501

Clinical Pharmacology Operations Research Associate Resume Examples & Samples

10%
Leads and/or assists the study team to design, develop and deliver the clinical study in accordance with the clinical development plan/strategy, budget and timeline
May assist in authoring/contributing to clinical study documents such as ICFs, data monitoring plans, ICFs, study synopsis and study related plans developed by Clinical CROs and vendors
Contributes to the clinical review of CRFs, completion guidelines, and the data review plan
Leads/assists in the identification and selection of investigator sites
Assists and/or participates in planning and conduct of investigator’s meetings, monitoring visits, Site Selection, Site Initiation, Observation, Interim and Close-out Visits
Provides input and coordinates the on-schedule delivery, appropriate storage, and return or destruction of clinical trial supplies in collaboration with the clinical supply team
Collaborates with the cross-functional teams on selection and potentially management of clinical vendors
Liaises and coordinates with document specialists regarding study specific files for the Trial Master File
Manages the escalation of study related issues and communicates as appropriate with management and other R&D functions
May support or co-manage larger complex trials as necessary
Leads and/or assists in the oversight of CRO activities and other clinical vendors to ensure the quality meets Shire and regulatory requirements
Leads, assists, and/or monitors budget (accruals, forecasts, etc..) for clinical study (investigational sites and vendors)
Monitors the status of clinical data collection of assigned clinical studies
Assists in the review of clinical monitoring reports, case report forms, safety report reviews, and correspondence related to monitoring visits
Leads or assists in the maintenance of tracking information in the clinical trial management system. Oversees and monitors the management of the clinical study, ensuring it is conducted in accordance with the approved study plans
Maintains knowledge of therapeutic area, good clinical and medical practice and pharmaceutical regulations in order to ensure best practice across all activities
Supports department initiatives and process improvements
May generate or assist in critically evaluating proposals, contracts, and change orders from CROs and other vendors
Develops knowledge of therapeutic area, current medical practice and industry regulations in order to ensure best practice across all activities
Supports departmental initiatives and process improvements
Bachelor’s degree is required. Scientific/health care field preferred, but not required
Experience (2+ years) working in clinical research within a pharmaceutical company or CRO or similar organization
Strong knowledge of applicable computer and project management software packages, including Microsoft Word, Excel, Project, and Power Point
Familiarity with financial budgeting and forecasting/reporting
Requires strong attention to detail and the ability to establish priorities, schedule, and meet deadlines
Ability to work successfully within a cross-functional team and a matrix organization
Ability to interact with investigators, vendors, and internal colleagues
Knowledge of current regulatory requirements and guidelines governing clinical research

Scientist, Clinical Pharmacology Resume Examples & Samples

PhD with preferrably a MD background
Excellent in communication & Ability in working with cross-functional team
Solid training &knowledge in Clinical Pharmacology, PK/PDmodelingconcepts and basic statistics
Has established a good level of expertise and scientific reputation through publications and presentations
Ability to multi-task, prioritize assignments, and work under pressure, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning, organization, managing the job)

Clinical Pharmacology Modelling & Simulation Specialist Resume Examples & Samples

Have 0-3 years of pharmaceutical development experience
Solid training & knowledge in Clinical Pharmacology, PK/PD modeling concepts and basic statistics
Experience in the use of WinNonlin, R or S-plus, database management, or related scientific software (e.g. NONMEM)
Good understanding of clinical drug development and the overall pharmaceutical R&D process
Fluent in written and spoken English; Good written and oral communication skills and able to communicate effectively with individuals and groups in the organization (communication)
Assume responsibility and accountability for successfully completing assignments or tasks, proactively taking action to accomplish objectives, and setting high standards of performance (delivery of results)
Actively identify new areas for learning and application to the job (continuous learning)

Associate Director, Clinical Pharmacology Resume Examples & Samples

Provide leadership in developing DMPK and clinical pharmacology strategies for the life cycle management of Jazz products
Develop and execute DMPK protocols and pharmacokinetic components of nonclinical protocols
Represent clinical pharmacology in cross-functional discussions of regulatory planning and strategy
8+ years of corporate, government or academic pharmaceutical development experience preferred
8+ years of experience in scientific research is required
5+ years of experience with pharmacokinetic and pharmacokinetic/pharmacodynamic data analysis
Outstanding teamwork, presentation, written, and oral skills required
Formal training in Good Laboratory Practices

Validation Lead-clinical Pharmacology Unit Resume Examples & Samples

Validation strategy definition (Validation Master Plan)
Project planning for validation of computerized systems
Sets up requirement definitions in co-operation with the system users
Creates and maintains SOPs, work instructions, guidelines for system use
Coordinates and coaches validation and qualification activities
Qualification and validation execution
Writes qualification and validation documentation
Involved in QA and Q&C
User support during validation
Training
Coding & Mapping agreements definition and documentation
Configuration agreements
Validation of Data Management functions (cf. above)
Process definition and documentation
Is the subject-matter expert, responsible for compliance with the internal quality system. Provides direction and actively contributes to developing, improving and implementing Standard Operating Procedures and Working Instructions. Notifies any violation or deviation to the immediate supervisor or appropriate authority
Back-up for System Administrator
Internet Compliance Authority (ICA) CPU
Interacts with many levels and functions within the J&J organization; internally in the CPU as well as externally, such as Integrated Data Management, QM/QA, and A&TD
Interacts with the IM organizations responsible for applications (Pharma R&D IT) and infrastructure (ITS)
Connects with external suppliers of related instruments and software to monitor the technical evolutions in this area
Actively contributes to the development and maintenance of specific working instructions and SOPs
Develops productive partnerships with business partners and vendors
Credo: liaises with all the members of the Department and makes a positive contribution towards team spirit in collaboration with the Credo Team
Coaching of key users, business owner, and system administrator in validation activities
A Master’s and/or Bachelor’s degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics
Advanced course work in technical systems plus continued education in technical disciplines is preferred
Additional certification is a plus
Minimal 8-10 years’ working experience in a regulated environment
Good working knowledge of the ICH-GCP guidelines and other relevant regulations and regulatory guidelines
Good knowledge of project management
Able to apply technical/professional knowledge to the execution of clinical trials
Fluency in written and spoken English
Proficiency in written and spoken Dutch
Able to cope with administrative tasks
Extensive knowledge of computerized system validation, preferably experience with J&J PRD validation methodology
Extensive knowledge of 21 CFR Part 11
Knowledge of process modeling techniques
Insight/experience in validation of EDC systems
Experience in qualification of medical devices and lab equipment
Knowledge of testing methodologies
Strong organizational, operational and management skills
Strong written, verbal and interpersonal communication skills
Able to prioritize and multi-task
Able to establish and maintain effective working relationships
Good accuracy and attention to detail
Pro-active and creative in identifying and solving problems
Interested in early clinical research, practical medical work and contact with healthy volunteers and patients
Strong analytical and problem-solving skills
Excellent customer service, interpersonal, communication and team collaboration skills
Able to follow change management procedures and internal guidelines

Clinical Pharmacology Fall Internship Resume Examples & Samples

Research and report on clinical pharmacology topics such as pathophysiology of diseases, dose optimization strategy, influence of intrinsic and extrinsic factors on PK/PD, & drug-drug interactions
Develop PK/PD models by integrating biology, pharmacology, toxicology, biomarker in support of dose selection & communicate findings to teams
Senior student enrolled in Masters, PharmD, or Ph.D. program in Pharmaceutical Sciences
Hands-on experience in modeling software such as Phoenix, SimCYP, GastroPlus, SAS, R
Strong communication skills and the ability to influence, negotiate, and communicate with project teams
Passion for data analysis and applying new technologies to advance the science of clinical pharmacology

Director, Clinical Pharmacology Resume Examples & Samples

Drives the development and execution of the Clinical Pharmacology Strategy and Plan of a number of clinical development and/or program teams. Provides key components of the Early Development Plan, advises teams on Clinical Pharmacology strategy and science and provides input to line management. Works with clinical development and/or program teams to achieve program goals and provide deliverables in approved timeframes
Leads clinical pharmacology efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions. Analyzes results, interprets, and recommends action based on study results
Provides extensive regulatory strategy expertise for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents. Maintains cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent
Engages in cross-functional activities providing Clinical Pharmacology input and provides a source of Clinical Pharmacology expertise and advice to other functions across the Company. Participates in and provides Clinical Pharmacology perspective to cross-functional committees and activities
Maintains extensive scientific awareness and presence in Clinical Pharmacology, publishes multiple manuscripts and posters, presents at Scientific Conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large
Manages and/or mentors junior staff within the function. Develops expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serves as a reference source in these for his peers
Extensive experience in developing and executing Clinical Pharmacology Strategy and Early Development Plans
Strong regulatory strategy expertise for drug filings and experience with Clinical Pharmacology sections of regulatory documents
Demonstrated ability to work cross functionally to provide Clinical Pharmacology perspective & expertise across the organization
Strong publication, presentation and poster record demonstrating scientific excellence
Previous expertise in managing and mentoring junior staff
Strong English oral and written communication skills
Employs a continuous improvement in knowledge and practical understanding of clinical pharmacology and pharmacometrics principles and applies this knowledge in a program team setting

Contracts Associate, Clinical Pharmacology Resume Examples & Samples

Develop, review and negotiate Confidentiality Agreements, Letters of Intent, Services/Consulting Agreements, Laboratory Service Agreements, Master Services Agreements, and Price and Payment Schedules
Lead negotiations for all assigned Agreements with moderate management/subject matter expert support
Follow up on outstanding contract issues for resolution to meet internal and external deadlines and to minimize business and legal risk
Work cross-functionally within the client experience team to resolve contract and billing issues in a timely manner
Perform accurate maintenance of SFDC (e.g. timely and accurate data entry)
Provide accurate updates on all outstanding contractual documents to Management on a weekly basis or as otherwise required through required systems or tracking mechanisms
Minimum of 2-4 years in the pharmaceutical or CRO industry with minimum of 1 year of contract management related experience
Demonstrated ability to plan, multi-task and prioritize
Demonstrated teamwork, communication, and organizational skills
Proficient in Excel and Word (intermediate)
Problem Solving and Negotiation skills
Excellent customer service skills, attention to detail and ability to be persistent while maintaining tact
Proven ability to work independently
Experience and comfort in a high volume, fast-paced environment is essential

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