Global Development Lead, Internal Medicine; MD, Sr. Director

Role Summary

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 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 subject matter expert in their therapeutic area and in clinical drug development.

• 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 programming.
• 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.

• Cardiologist 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, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer.
• Demonstrated experience managing and training large teams in clinical development.
• Demonstrated experience in designing and launching large teams preferred.

• Medical / Scientific credibility/Excellence - Track record of achievement in pharmaceutical development, able to coordinate and execute clinical development or lifecycle strategy. Demonstrated understanding of the complexities and recent developments in the principal disease areas; confident discussing scientific / mechanistic aspects of drug development, also comfortable in discussing commercial and regulatory issues.
• Management experience - Able to work in a highly complex matrixed environment and able to influence cross-functional teams.
• Leadership - Persuasive and effective leader of staff.
• Influencing - Able to manage and motivate internal teams on clinical trials.
• Conflict Management - Able to act as mentor / coach to others to improve conflict management skills; steps up to conflicts, seeing them as opportunities; reads situations quickly; can hammer out tough agreements and settle disputes equitably; prepared to take responsibility for a decision made and support this, even though it may be unpopular.
• Team Building - Shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates strong morale and…