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 at Pfizer. The role leads the cross-functional Clinical Development Team across clinical, pharmacology, statistics, safety, commercial, patient access, and operations to design, execute, and interpret studies for worldwide regulatory submissions. The GDL creates and secures endorsement for the Clinical Development Plan and protocol design documents and serves as an internal subject matter expert in the therapeutic area and in clinical drug development. They may also lead additional clinical opportunities in support of the Obesity portfolio and partner with external companies as part of Pfizer’s Partner of Choice model.

• 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

Qualifications

• 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).

Skills

• Medical / Scientific credibility and excellence in pharmaceutical development; ability to coordinate and execute clinical development or lifecycle strategy.
• Management experience in a highly complex matrixed environment with ability 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: mentor/coach to improve conflict management skills; resolve conflicts equitably.
• Team Building: fosters open dialogue, builds morale, and creates a sense of belonging to the team.
• Accountability: takes personal responsibility for results and drives toward goals.
• Change agility: able to navigate uncertainty and get things done amidst organizational change.
• Demonstrates breadth of diverse leadership experiences and capabilities including influencing, developing others, and guiding colleagues to achieve meaningful outcomes.

Education

• MD or DO

Additional 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.