Description
The Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine, Research & Development, Pfizer.
The individual will lead the cross-functional Clinical Development Team including but not limited to clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues in the design, execution and interpretation of studies in support of worldwide regulatory submissions.
The individual will be accountable for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents.
Responsibilities
- Partners effectively with the Medicine Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget.
- Responsible for comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan) along with creating the pediatric investigation plan / pediatric study plan and associated protocol design documents working closely with individual trial clinicians to ensure trial feasibility and optimized operational execution.
- Provides product/program specific input for target product profile(s).
- Willingness to bring innovative thinking and bold decision making across clinical development programs and individual studies.
- Develops specific clinical development enabling strategies including digital/ innovation and patient engagement approaches.
- Partners with Trial clinicians on governance reviews (incl Sci/Ops) for assigned clinical studies.
- Provides therapy area/ indication expertise in support of clinical review of clinical data.
- Provides specialized medical monitoring support for individual trial team, if required.
- Key partner in trial-level statistical analysis plan, table-listings-figures, database release in partnership with statistics and programing.
- Develops submission level deliverables (IAP, IARP and submission TLFs).
- Support appropriate interpretation and communication of clinical trial data.
- Review and approve submission level safety narrative plan.
- Supports product label development and maintenance.
- Engage key external stakeholders.
- Provides regulatory submission support.
- Ensures compliance with internal SOPs and external regulatory standards.
BASIC QUALIFICATIONS
- MD or DO
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex, global development programs.
- 8 + years of relevant experience and track record of success in academia and/or the biopharmaceutical industry in clinical research and development.
- Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
- Demonstrated clinical/medical, administrative, and project management capabilities.
Competency Requirements
- Medical / Scientific credibility/Excellence
- Management experience
- Leadership
- Influencing
- Conflict Management
- Team Building
- Accountability
- Change agile
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Up to 30% travel may be required.
- Relocation support available.
- Hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.