Global Clinical Development Lead Job Description

Global Clinical Development Lead Job Description

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Global clinical development lead provides oversight of conduct of clinical development projects per Abbott EPD Global Clinical Quality System, and ICH GCP regulations.

Global Clinical Development Lead Duties & Responsibilities

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

Sample responsibilities for this position include:

Integrate nutrition and nutritional physiology knowledge in the development programs and strategy
May supervises a variable number of CD professional and administrative staff
Lead/participate as needed in investigator meetings, advisory committee, and scientific meetings
Collaborates with Global Development Team Lead, Therapeutic Area Head, Business Unit Leaders, Clinical Operations, and Global Medical Affairs to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent
Provides medical and scientific advice within Shire R&D and other functions
Provides input to global publication strategy for the projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements
Contributes to platform and technology strategies
Provides support to publication strategy for the projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements
Responsibilities will include leading design and supervision of Shire sponsored clinical trials leading medical interpretation of data analyses
May supervise a variable number of CD professional and administrative staff

Global Clinical Development Lead Qualifications

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

Education for Global Clinical Development Lead

Typically a job would require a certain level of education.

Employers hiring for the global clinical development lead job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Gastroenterology, Life Sciences, Conducting, Psychiatry, Neurology, Medical School, Hematology, Medical, Biotechnology, Health Sciences

Skills for Global Clinical Development Lead

Desired skills for global clinical development lead include:

Global pharmaceutical industry
Regulations relating to drug development and promotional activities
Development programs and strategy
Relationship building with external partners and cross-functional internal teams to execute clinical development programs
Device FDA
GCP
ICH
MDR guidelines
Baxter portfolio is helpful
Clinical research concepts

Desired experience for global clinical development lead includes:

Bachelor's degree or advanced degree in science or computer related field
A moderate amount of domestic and/or international travel (20%) may be required
Experience in Submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or experience in designing and conducting Phase II-III clinical trials
Work with the Program Lead, team members and governance bodies to translate the FDT strategy into protocols and action plans
Work with the Program leads to author clinical protocols and related documents, including Clinical study reports, clinical regulatory documents including integrated summaries and clinical overview
Contributes to DSURs and PSURs

Global Clinical Development Lead Examples

1

Global Clinical Development Lead Job Description

Job Description Example
Our company is looking for a global clinical development lead. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for global clinical development lead
  • Work with the Development Teams, Global Molecule Teams and Sleep-Franchise Team Leads to shape the drug development strategies in alignment with the Therapeutic Area strategy and priorities
  • Oversee the translation of the Development and LCM strategies into operational plans
  • Prepare for Development Strategies and Operational Plan decision making by the appropriate governance bodies, in alignment with Jazz governance principles
  • Ensure overall projects stay on track and in line with strategic objectives by supervising development projects within a therapeutic area with shared accountability with the assigned Project Manager for overall project execution
  • Present project progress, key issues, analysis and recommendations to the Development Review Committee (DRC)
  • Work with Project managers (PMs), Global Molecule Lead (GML) and/or Sleep TAH/Sleep-Franchise Team leads to escalate issues and to resolve issues in alignment with R&D Governance process
  • Provide technical advice and leadership into projects, informed by expertise in the therapeutic area utilizing internal and external technical experts
  • Serve as member of Therapeutic Area Core team
  • Advise Sleep TAH, Sleep-Franchise Team Leads and Head of R&D Operations on project strategy and resource planning
  • Provide Sleep TAH, Sleep-Franchise Team Leads and Head of R&D Operations with insight into the development project process and important risks
Qualifications for global clinical development lead
  • Addresses relevant clinical queries from study sites and authors responses to study related IRB and HA questions
  • MD preferably with a back ground in clinical oncology
  • Can work consistently in a matrix environment with relevant teams such as Clinical Operations, GBS, Global Safety, etc
  • Can handle multiple, complex, studies in parallel
  • Has a history of prior meaningful participation in regulatory submissions
  • Has a history of strong interaction with thought leaders
2

Global Clinical Development Lead Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of global clinical development lead. 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 global clinical development lead
  • Work with functional heads to ensure all project team/sub-teams have appropriate representation and leadership as needed, including personal leadership and, when appropriate, delegated development representation
  • Provide input and info to Sleep TAH, Sleep-Franchise Team Leads on upcoming R&D governance meetings as appropriate
  • Lead Clinical Development Function in Sleep Medicine, including supervisory responsibility of Clinical Development staff, departmental administrative responsibilities for budget and R&D governance responsibilities wherever VP, Clinical Development roles are required
  • Support Corporate Development technical assessment of new opportunities
  • Develop and execute portfolio clinical strategies for both product development and life cycle management, in support of the GI health strategy
  • Provide outstanding clinical and scientific leadership and support for the GI Health Category
  • Develop clinical development plans driven by intended use (claims) and value propositions
  • Ensure their integration into Evidence Development Plans (EDPs), consider development path, intellectual property, areas of unmet needs, epidemiology, regulatory and market access
  • Integrate diagnostics and pharmaceutical therapy with nutrition as key part of the therapy, ideally leading to new standard of care of treatment
  • Represent clinical development before regulatory agencies, payers and other medical decision making committees
Qualifications for global clinical development lead
  • Exhibits capable team leadership
  • The position is preferably based in the Princeton, NJ area but may be based in another R&D site or selected BMS subsidiary depending on business needs
  • Therapeutic expertise in Neuroscience (neurology or psychiatry) preferred
  • Sub-specialty postgraduate medical training strongly preferred
  • A minimum of 4 years post-medical graduation (or 8 years for Senior role) with at least 2 years post-graduate research experience
  • Reporting to the VP/Global Development Lead, the Global Clinical Development Lead (GCDL) will serve a key role of providing expert medical input to clinical development programs
3

Global Clinical Development Lead Job Description

Job Description Example
Our growing company is looking for a global clinical development lead. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for global clinical development lead
  • Make clinical presentations to key stakeholders in academia, regulatory agencies, and reimbursement bodies to help establish medical value, clinical utility and credibility of NHSc products
  • In coordination with Clinical Operations, oversee trial design and protocol development, study execution and data communication, including scientific presentations and publications
  • Ensure that all procedures are fulfilling legal, regulatory and safety requirements
  • Develop and execute portfolio clinical strategies for both product development and life cycle management, in support of the Critical Care strategy
  • Provide outstanding clinical and scientific leadership and support for the Critical Care Category
  • Serve as senior NHSc Critical Care and Nutrition clinical expert internally
  • Represent clinical development in due diligence and other assessments of external opportunities
  • Collaborates with Global Development Lead, Therapeutic Area Head, Business Unit Leaders, Clinical Operations, and Global Medical Affairs to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent
  • Develop and execute global clin dev strategy, and communication of the global scientific/medical evidence plan
  • Provide clinical/scientific input during the development and execution of clinical trials, including key observational studies
Qualifications for global clinical development lead
  • Will lead development of the Clinical Strategy/Clinical Development Plan (CDP)
  • Minimum 3 years’ experience in Clinical Development in Biotech/Pharmaceutical industry
  • Ten or more years of experience leading or overseeing sleep or CNS disorders-related pharmaceutical development projects to include managing such projects across multiple functional areas
  • Demonstrated ability to successfully execute development plans
  • Significant experience with NDA/BLA preparation and submissions
  • Advanced Doctoral Degree required
4

Global Clinical Development Lead Job Description

Job Description Example
Our company is looking to fill the role of global clinical development lead. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for global clinical development lead
  • Provide outstanding clinical and scientific leadership and support for the Metabolism Category
  • Serve as senior NHSc Metabolism and Nutrition clinical expert internally
  • Direct the development of clinical strategies and plans to integrate compounds into standard practice
  • Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities
  • Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
  • Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders
  • Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy
  • Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, pharmaceutical or biotechnology industry collaborators/partners
  • In addition to leading and supervising the Clinical Research Department, this role will have direct line responsibility for the Clinical Affairs and Clinical Operations Departments
  • Develop and execute portfolio clinical strategies for both product development and life cycle management in the field of Pediatric Medical Nutrition (including novel nutritional therapeutics) in support of the Category business objectives
Qualifications for global clinical development lead
  • Reporting to the Global Development Team Lead, the Global Clinical Development Lead will serve a key role of providing expert medical input to one or potentially more clinical development programs
  • Experience with projects relating to Sleep Medicine or CNS
  • Demonstrated ability to lead and influence experienced professionals
  • Broad knowledge and exposure across all R&D functions
  • Deep understanding of pharmaceutical development
  • In depth experience with design and management of clinical trials
5

Global Clinical Development Lead Job Description

Job Description Example
Our company is growing rapidly and is hiring for a global clinical development lead. 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 global clinical development lead
  • Drive the translation of product clinical development plans into study-specific protocols, develop and secure approval of protocols and provide expertise on clinical trial methodology, and therapeutic area of interest
  • Jointly with Clinical Operations, oversee the planning and execution of clinical studies to ensure quality, compliance and timeliness of studies and results
  • Contribution to statistical analysis plans
  • Develop and maintain relationships with KOLs to deliver high value clinical studies and communications for NHSc category products, and make clinical presentations to key stakeholders in academia, regulatory agencies, reimbursement bodies to help establish medical value, clinical utility and credibility of NHSc products
  • Oversee market trial design, execution and communication, in collaboration with Regional Medical Director
  • In this role, as a team member, you proactively provide QA leadership to the strategy of Global Clinical Teams (GCT) for assigned trials by ensuring considerable organization awareness
  • The following elements are key to succeed in your mission to support implementation of the quality strategy within GCT under responsibility
  • Developing a clinical strategy to effectively and efficiently support the global evidence generation strategy (GEGS) for Acute Therapies
  • Cross-functional engagement with Medical Affairs, Clinical Operations as well the Commercial Leadership globally and with key geographies to create the evidence generation strategies that support the registration, launch and market adoption and maintenance on the market for products within the Acute segment and potential other segments of Med Del/Acute business
  • Building together with the Health Economic expert the evidence plans to achieve best value-based selling opportunities (including Health Technology recognition)
Qualifications for global clinical development lead
  • Ability to analyze, interpret and make decisions on complex scientific information
  • Ability to effectively address inquiries from investigators, customers, internal teams and external agencies
  • Experience in leading clinical development programs successfully from early through late Phase, registration and market launch
  • Experience in regulatory submissions to the FDA and other regulatory agencies, including interaction with these agencies on novel trial designs and new indications the ability to effectively address inquiries from investigators, customers, internal teams and external agencies
  • Experience in building and leading an R&D therapeutic area in a high-growth environment
  • Expertise in medical writing and verbal communication (protocols, clinical reports, regulatory submission documents, peer-reviewed publications, scientific meetings) Relevant clinical experience highly desirable

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