Clinical Pharmacology Job Description

Clinical Pharmacology Job Description

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Clinical pharmacology provides the Clinical Pharmacology components of clinical protocols: direct the planning of all relevant PK/PD analyses, using innovative methods to integrate knowledge of PK, PD, patient characteristics and disease states to optimize dosing, regimens and study designs in collaboration with Clinical Development, Clinical Operations and Biostatistics.

Clinical Pharmacology Duties & Responsibilities

To write an effective clinical pharmacology job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical pharmacology job description templates that you can modify and use.

Sample responsibilities for this position include:

Ensuring that clinical pharmacology requirements of markets are understood and incorporated upfront from product concept development
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
Contribute to the clinical pharmacology sections of regulatory documents, including Investigator Brochures, EOP2 meetings, NDA/BLA/MAA
Participates in designing the early development plan and overall translational medicine and clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the Company
Acts as a primary ED&CP liaison for vTMF collaborating with internal partners to support implementation and optimization of vTMFincluding any additional new platforms in the future acting as a Subject Matter Expert for Early Development & Clinical Pharmacology
Ensures the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology
Development and execution of clinical pharmacology strategies for late stage development programs from Proof-of-Concept (Phase 2a) through worldwide marketing application
Development and execution of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, and clinical pharmacology studies for programs in Phases 1 through 4 of development
Provide clinical pharmacology support for programs through the worldwide marketing application filing including supportive registration documents and presentations
Provide clinical expertise for new targets in the Target Identification, Target Validation and Lead Identification space including participation in the selection of targets, and the design of preclinical pharmacology experiments to validate specific targets and/or pathways

Clinical Pharmacology Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Clinical Pharmacology

List any licenses or certifications required by the position: ECVP, ACVP, DVM, DABT, HIV, BLS, RAPS, RAC

Education for Clinical Pharmacology

Typically a job would require a certain level of education.

Employers hiring for the clinical pharmacology job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Pharmacology, Pharmaceutical Sciences, Biomedical Engineering, Biological Sciences, Science, Health, Pharmacy, Engineering, Life Sciences, Life Science

Skills for Clinical Pharmacology

Desired skills for clinical pharmacology include:

Pharmacology
ICH and local regulatory authority regulations regarding drug
Available treatment paradigms
Disease processes and mechanisms
Clinical and regulatory landscape
PK
Disease states
Patient characteristics
Patient populations within assigned Therapeutic Area
Bioanalytical chemistry

Desired experience for clinical pharmacology includes:

Available for 30% to 50% travel, both domestically and/or internationally
People management responsibility for all staff within his / her group
Besides the LTM tasks, a Sr
Leads and coordinates local trial team(s) activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations
Maintains and updates trial management systems
May lead and coordinate negotiation of trial site contracts and budgets

Clinical Pharmacology Examples

1

Clinical Pharmacology Job Description

Job Description Example
Our innovative and growing company is hiring for a clinical pharmacology. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical pharmacology
  • Assessment of Gastroplus® as predictive tool for human PK from pre-clinical data
  • Perform population PK analyses on drug candidates as they progress through clinical development
  • Provide expert PK/PD advice to cross-function project teams
  • Approval of design, analysis, interpretation, reporting and corresponding regulatory documents in all programs that relate to clinical pharmacology and pharmacometric aspects
  • Take responsibility for a team of CPMS colleagues aligned to a therapeutic area (TA) and Discovery performance units (DPU) to ensure that projects and the R&D pipeline receive optimal clinical pharmacology and pharmacometric support
  • Provide expertise in clinical pharmacology strategy in a specific domain, therapy area or analyses methodology
  • Conducts trial team meetings and provides or facilitates TM/SM training when needed
  • Interacts effectively with managers from various disciplines
  • Coordinates the translational medicine subteam meetings
  • Coordinates activity of the clinical study director of assigned project(s)
Qualifications for clinical pharmacology
  • Ability to provide pharmacokinetic and modeling support to project teams working on new formulations and new products, those supporting marketed products
  • Proficiency in WinNonlin/Phoenix is preferred
  • Basic scientific computing and programming skills in a variety of computational tools such as MATLAB, Monolix, NONMEM, Mathematica, R and excellent working knowledge of Linux and Windows environments
  • Excellent communication skills and ability to work independently member of an interdisciplinary team are essential
  • Engage in continuous learning around basic and clinical science
  • Mentor and direct others as needed
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Clinical Pharmacology Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of clinical pharmacology. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for clinical pharmacology
  • Communicating quantitative clinical pharmacology PK/PD core activities at a project and clinical team level in a manner that promotes productive relationships
  • 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
  • Lead, with a high degree of independence, the clinical pharmacology & pharmacometrics strategy for a portfolio program, working in conjunction with the Clinical Program Director, Clinical scientists, Biostatisticians, and other CDT colleagues
  • Independently undertake and/or lead the high quality review and interpretation of clinical pharmacology study results and oversees the presentation thereof in clinical study reports and related study documentation
  • Provide effective clinical pharmacology contributions to regulatory documents including Investigator Brochures, Labelling and those required for regulatory meetings and regulatory filings
  • Be able to provide support to Research and Translational Science and in the development of preclinical PK-PD knowledge required for early clinical development strategy, utilizing Pharm-Tox data appropriately in the development of early clinical studies
  • Collaborate with external network in the field of clinical pharmacology, modeling & simulation
  • Participates in the dose selection for first-in-human studies, Go/No Go decisions when needed
  • Ensures an adequate follow-up of studies and project timelines
  • Communicates project team discussions of interest to the other group members who are involved with the project
Qualifications for clinical pharmacology
  • BS, MS, PharmD, PhD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences
  • PhD, PharmD or equivalent degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences
  • In-depth knowledge of pharmacokinetic and pharmacodynamic principles
  • Phoenix required
  • PharmD or MS/PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related discipline
  • PhD or MD/PhD in an area relevant to clinical pharmacology and pharmacometrics with at least 5+ years of proven record in drug development from IND through regulatory submission and commercialization
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Clinical Pharmacology Job Description

Job Description Example
Our company is growing rapidly and is looking for a clinical pharmacology. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical pharmacology
  • Perform data analysis using WinNonlin to calculate various PK parameters in ocular tissues
  • Integrally involved in assessing and managing analyses of PK/PD data, integrating clinical trial simulation strategies and disseminating the clinically relevant risk/benefit implications to the clinical development teams
  • Presents data in appropriate meetings (inside or outside the Group)
  • Be responsible for North America oversight and management of Trial Master Files (paper and electronic) and the clinical trial associate work performed external flex workers
  • Provide resource allocation support, review of project assignments with oversight of quality of regulatory documents/files, inspection readiness, reconciliation of vTMF documents uploaded by the Central Import Team, onboarding, and ensures training of flex workers
  • Interface with ED&CP leadership team and global FMs to ensure communication of important vTMF clinical updates impacting management of critical documents and files
  • Assure support to all assigned projects is optimal in terms of quality, timing and cost
  • 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 external stakeholders like global Health Authorities
  • Develop and support external contacts (investigators, academic and regulatory community, partners in collaborations)
  • Development and execution of the early clinical development strategy for novel therapy programs from Preclinical Candidate approval through clinical Proof-of-Concept (Phase 2a)
Qualifications for clinical pharmacology
  • Educational degree is expected in a relevant scientific area, , Pharmacology, Pharmacokinetics, Pharmacodynamics, Drug Metabolism, Pharmacy
  • Deep knowledge of Clinical Pharmacology and the application of Modeling & Simulation
  • Track record of successful experience in the Clinical Pharmacology areaAble to understand clinical effects, pharmacological, physiological and biochemical understanding
  • Ability to effectively contribute to interdisciplinary team meetings and, able to effectively leading sub-teams
  • Experience supporting Clinical Pharmacology studies preferred
  • Ability to communicate with non-statisticians to interpret statistical findings
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Clinical Pharmacology Job Description

Job Description Example
Our company is growing rapidly and is looking for a clinical pharmacology. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for clinical pharmacology
  • Provide clear, timely communication and interpretation of study results to therapeutic area governance, functional area experts and development review committees
  • Contribute to assessment of internal and external opportunities identified by Business Development and Licensing
  • Assay trouble shooting, development of new technology platforms (SPARCL, Singulex, ) and assay automation
  • Will provide Pharmacometrics strategic leadership to early and late stage assets
  • The results will need to be presented and discussed at one of the group meetings
  • Thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy
  • Implementing best practices, trends, learnings, etc from internal and external sources to further CPMS contribution to R&D pipeline
  • Highly influential, define and execute a co-ordinated scientific and/or technical strategy (18-24 months planning horizon)
  • Ability to identify talent, provide appropriate coaching to ensure future leadership/succession plans for the CPMS organization
  • Participates in the role of Subject Matter Expert in the creation, review and revision of SOPs
Qualifications for clinical pharmacology
  • Experience working in an outsourcing model (fully or functional outsourcing)
  • Demonstrated project and technical leadership qualities, and creative and strategic thinking preferred
  • Ability to program using SAS
  • Knowledge of relevant FDA and CHMP guidelines
  • Experience with regulatory interactions in the US
  • Experience with regulatory interactions outside the US
5

Clinical Pharmacology Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical pharmacology. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for clinical pharmacology
  • Provide high quality discipline expertise and contributions to Clinical Pharmacology Development Strategies of your projects
  • Develops productive working relationships with hospital colleagues and with colleagues at the Unit and other groups in the company to facilitate the smooth operation of the group
  • Liaises effectively with all members of the Unit and makes a positive contribution towards team spirit in the Unit
  • Actively contributes to the development and review of Standard Operating Procedures, Working Instructions, policies and guidelines
  • Makes an active contribution to the validation and implementation of new systems, methods and assessments
  • Complies with national and international laws and regulatory body guidelines, and laws on health and safety at work, fire prevention and other appropriate legislation
  • Assists the CPU Management Team
  • Is supervisor for all on-call temporary staff including those involved in the Clinic, the Recruitment Center, Flex-Lab, Cleanroom and Logistical Support Staff dedicated to the CPU
  • Effectively contributing to interdisciplinary team meetings and, able to effectively leading sub-teams
  • Anticipating program needs and problem-solve, sharing critical data within the team and the line and proactively proposing solutions
Qualifications for clinical pharmacology
  • English proficiency with strong presentation and communication skills
  • Ability and willingness to represent Clinical Pharmacology on project teams
  • Ability to work in a complex multi-disciplinary and global environment
  • Experience in designing and managing clinical studies
  • Hands on experience in non-compartmental, population, PK/PD analysis
  • Experience in specific therapeutic area(s) of interest (CNS, Respiratory diseases)

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