
Global Development Lead (non-MD ED)
Pfizer, S.A. de C.V, Cambridge, MA, United States
United States - Massachusetts - Cambridge
United States - Connecticut - Groton
United States - Pennsylvania - Collegeville
United States - New York - New York City
We are in relentless pursuit of breakthroughs that change patients’ lives. Pfizer’s research and development pipeline is the essence of our mission to bring life‑changing medicines to the world.
Job Summary
The Global Development Lead (GDL) is the single clinical point of accountability for clinical development of assigned assets in Internal Medicine within Pfizer. The GDL leads a cross‑functional Clinical Development Team—including clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations—to design, execute, and interpret studies for worldwide regulatory submissions.
Job Responsibilities
Partner with the Medicine Team Lead to negotiate tradeoffs, milestones, and ensure delivery of the clinical program in line with agreed timelines and budget.
Develop comprehensive clinical development plans to secure approval and reimbursement globally, including China and Japan, and create pediatric investigation plans and protocol design documents in partnership with trial clinicians to ensure feasibility and optimized operational execution.
Provide product/program specific input for target product profiles.
Bring innovative thinking and bold decision‑making across clinical development programs and individual studies.
Develop clinical development enabling strategies, including digital innovation and patient engagement approaches.
Partner with trial clinicians on governance reviews (incl. SRC) for assigned clinical studies, providing strategy input and insights.
Provide therapy area/indication expertise in support of clinical review of data—including CRF design, signal interpretation, and adverse event contextualization.
Key partner in trial‑level statistical analysis plans, table‑listing‑figures, and database release in partnership with statistics and programming.
Develop and deliver submission‑level deliverables (IAP, IARP, TLFs) and support SCE and SCS.
Support interpretation and communication of clinical trial data.
Review and approve submission‑level safety narrative plans.
Support product label development and maintenance.
Engage key external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients, and patient advocates) to drive strategic insight generation for clinical strategy and product development.
Provide regulatory submission support (DSUR, PBRER, disclosure deliverables, product defense).
Ensure compliance with internal SOPs and external regulatory standards.
Review IIR proposals.
Qualifications
Required: PharmD, PhD, DVM, or MS.
Minimum experience: Non‑MD (PharmD – 5+ years; PhD – 7+ years; DVM – 5+ years; MS – 10+ years).
Preferred: 15+ years of experience in academia and/or the biopharmaceutical industry in clinical research and development.
Experience across all phases of development, including early and late phases, across multiple therapeutic areas.
Experience with NDA submissions and large complex global development programs.
Experience working in areas beyond clinical (e.g., medical affairs).
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
Demonstrated clinical/medical, administrative, and project management capabilities, and effective communication skills inside and outside Pfizer.
Experience managing and training large teams in clinical development.
Experience designing and launching large teams (preferred).
Competency Requirements
Medical / Scientific credibility & excellence – track record in pharmaceutical development and clinical lifecycle strategy.
Management – influence cross‑functional teams in a complex matrixed environment.
Leadership – persuasive effective leader of staff.
Influencing – motivate internal teams on clinical trials.
Conflict Management – mentor/coach others, resolve conflicts decisively.
Team Building – foster open dialogue, shared wins, strong morale.
Accountability – take responsibility for results, push self and others to exceed goals.
Change Agility – thrive amid organizational change.
Broad leadership experience to create business impact.
Compensation and Benefits
The annual base salary ranges from $254,100 to $423,500. The position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25% of the base salary and a share‑based long‑term incentive program. Additional benefits include 401(k) with matching, paid vacation, holiday and personal days, paid caregiver/parental leave, medical, prescription drug, dental, and vision coverage. Relocation support may be available.
Travel Requirement
Up to 30% travel may be required.
Work Location
This is a hybrid role requiring you to live within commuting distance and work on‑site an average of 2.5 days per week.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws. If you are a licensed physician and incur recruiting expenses that Pfizer pays or reimburses, your name, address and the amount of payments will be reported to the government. For questions, contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in all aspects of employment and complies with all applicable laws governing nondiscrimination, work authorization, and employment eligibility verification. This position requires permanent work authorization in the United States. Pfizer is an E‑Verify employer.
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