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, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues—to design, execute, and interpret studies in support of worldwide regulatory submissions, and to develop and secure endorsement for the Clinical Development Plan and associated protocol design documents.
Responsibilities
- Partners effectively with the Medicine Team Lead to negotiate trade‑offs, milestones, and ensure delivery of the clinical program in line with agreed timelines and budget.
- Develops and implements a comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan), and creates the pediatric investigation plan / pediatric study plan and associated protocol design documents.
- Provides product/program specific input for the target product profile(s) and clinical data review, including CRF design, signal interpretation, and contextualization of adverse events.
- Brings 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 for assigned clinical studies and provides category‑level clinical development strategy input.
- Provides specialized medical monitoring support for individual trial teams, if required.
- Key partner in trial‑level statistical analysis plan, table‑listings‑figures, and database release in partnership with statistics and programming.
- Develops submission‑level deliverables (IAP, IARP, submission TLFs) and is responsible for submission deliverables including SCE and SCS.
- Supports appropriate interpretation and communication of clinical trial data and review/approval of submission‑level safety narrative plan.
- Supports product label development and maintenance.
- Engages key external stakeholders—such as Advisory Boards, Steering Committees, Data Monitoring Committees, and patient advocates—to drive strategic insight generation for 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.
- Reviews IIR proposals.
Basic Qualifications
Education
MD or DO.
Experience
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex, global development programs.
- 8+ years of relevant experience and a 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, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management capabilities, and effective verbal and written communication skills with individuals inside and outside Pfizer.
- Demonstrated experience managing and training large teams in clinical development.
- Demonstrated experience in designing and launching large teams.
Competency Requirements
- Medical / Scientific credibility/Excellence—track record of achievement in pharmaceutical development and ability to coordinate and execute clinical development or lifecycle strategy.
- Management experience—able to work in a highly complex matrixed environment and influence cross‑functional teams.
- Leadership—persuasive and effective leader of staff.
- Influencing—able to manage and motivate internal teams on clinical trials.
- Conflict Management—mentoring/coaching others to improve conflict management skills and settle disputes equitably.
- Team Building—creates a strong morale and spirit in the team and fosters open dialogue.
- Accountability—takes personal responsibility for results and delivers outcomes.
- Change agility—demonstrates perspective and poise in the face of uncertainty and gets things done amid organizational change.
- Broad leadership experience—ability to influence and collaborate with peers, develop and coach others, and create business impact.
Non‑Standard Work Schedule, Travel, or Environment Requirements
Up to 30% travel may be required.
Relocation support available.
Work location: hybrid role requiring on‑site work an average of 2.5 days per week.
Annual base salary ranges from $274,500.00 to $457,500.00 (U.S.); in Tampa, FL from $228,700.00 to $381,100.00. Eligible for participation in Pfizer’s Global Performance Plan (bonus target 25.0% of base salary) and long‑term incentive program.
Benefits include a 401(k) plan with matching contributions, paid vacation, holiday and personal days, caregiver, parental, and medical leave, and health benefits (medical, prescription drug, dental, vision). Eligibility and salary ranges vary by location.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. Reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment, work authorization and employment eligibility verification requirements. Pfizer is an E‑Verify employer. This position requires permanent work authorization in the United States.
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