Unknown Company

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

pearl river, ny • Posted 2 weeks ago
Hybrid Full Time Bio & Pharmacology & Health

Responsibilities:

  • Lead cross-functional Clinical Development Team for assigned Internal Medicine asset(s) through study design, execution, and interpretation for worldwide regulatory submissions.
  • Own and gain endorsement for the Clinical Development Plan and associated protocol design documents.
  • Create pediatric investigation/study plan and protocol design documents to ensure trial feasibility and optimized execution.
  • Negotiate tradeoffs, milestones, and ensure delivery of clinical program within agreed timelines and budget.
  • Provide product/program input for target product profile(s).
  • Drive innovative, bold clinical development decisions; develop clinical development enabling strategies (digital/innovation and patient engagement).
  • Partner with trial clinicians on governance reviews (incl. Sci/Ops); provide category clinical development strategy input.
  • Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
  • Provide specialized medical monitoring support if required.
  • Contribute to trial-level statistical analysis plan, TLFs, table-listings-figures, and database release with statistics/programming.
  • Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative plan.
  • Support interpretation/communication of clinical trial data; support product label development and maintenance.
  • Engage external stakeholders (Ad boards, Steering Committees, DMC, adjudication committees, patients/advocates) to support clinical development strategy and PDD development.
  • Provide regulatory submission support (DSUR, PBRER) including product defense; ensure compliance with internal SOPs and external regulatory standards.
  • Review IIR proposals.

Basic Qualifications:

  • MD or DO.
  • 8+ years of relevant experience in clinical research and development (academia and/or biopharma), with Phase 1–3 clinical development and translational medicine experience.
  • Background in chronic weight management, endocrinology, or internal medicine.
  • Extensive knowledge of global/regional regulation, ICH/GCP, and adverse event management.
  • Demonstrated medical/clinical, administrative, and project management capabilities; effective verbal/written communication.
  • Demonstrated experience managing/training large teams; designing/launching large teams preferred.

Additional Competencies/Skills:

  • Ability to coordinate/execute clinical development or lifecycle strategy; influence cross-functional teams in a matrix.
  • Leadership, influencing, conflict management, team building, accountability, and change agility.

Benefits:

  • Participation in Pfizer Global Performance Plan (bonus target 25%) and eligibility for share-based long-term incentive.
  • 401(k) with matching contributions and additional retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.

Work/Environment:

  • Up to 30% travel; hybrid role (on-site ~2.5 days/week).

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Global Development Lead, Internal Medicine, Sr. Director (MD) in pearl river at Unknown Company

This position is listed as full time and hybrid.

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