Global Development Lead, Internal Medicine, Sr. Director (MD)

Global Development Lead

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. The GDL is a key partner for other clinical and clinical operations colleagues through the lifecycle of all studies for the assigned asset(s). The GDL may also act as a key partner to external companies in support of Pfizer's Partner of Choice model. The individual is expected to be an internal subject matter expert in their therapeutic area and in clinical drug development.

They may assume responsibility for other clinical leadership opportunities in support of the Obesity portfolio. This may include responsibilities for trial design, execution and reporting of clinical trials for other late-stage assets in the portfolio. In addition, this leader:

• May provide specialized monitoring support if required
• Lead efforts on regulatory submissions and contribute to submission deliverables including the SCE, SCS and clinical overview.
• In support of assigned projects, provide input for target product profile(s), and regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk Evaluation Reports.

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 category clinical development strategy input and insights to trial clinicians for assigned clinical studies.
• Provides therapy area/indication expertise in support of clinical review of clinical data including CRF design, assistance in signal interpretation, contextualizing adverse events as required.
• 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). Responsible for submission deliverables including SCE and SCS
• 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 e.g., Ad boards, Steering Committees, DMC, Adjudication Committees, patients and patient advocates and other external stakeholders, to drive strategic insight generation to support clinical development strategy and PDD development.
• Provides regulatory submission support (DSUR, PBRER) submission disclosure deliverables and product defense.
• Ensures compliance with internal SOPs and external regulatory standards.
• Review IIR proposals

Basic Qualifications

Education

• MD or DO

Experience

• Background in chronic weight management, endocrinology or internal medicine with experience in Phase 1-3 clinical development and translational medicine.
• 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, as well as effective verbal and written communication skills in relating to individuals both inside and outside the organization.
• Demonstrated experience managing and training large teams in clinical development.
• Demonstrated experience in designing and launching large teams preferred.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Non-Standard Work Schedule, Travel or Environment Requirements

Up to 30% travel may be required.

Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.