Unknown Company

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

san diego, ca • Posted 2 weeks ago
Hybrid Full Time Bio & Pharmacology & Health

Responsibilities

  • Serve as clinical point of accountability for assigned Internal Medicine assets; lead cross-functional Clinical Development Teams (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations).
  • Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; partner throughout study lifecycle.
  • Lead obesity portfolio clinical leadership as needed (trial design, execution, reporting).
  • Lead governance reviews with trial clinicians; provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization).
  • Drive submission strategy and deliverables (IAP/IARP, submission TLFs; SCE/SCS; DSUR, PBRER; safety narrative plan; product label development/maintenance).
  • Contribute to target product profiles; support product defense.
  • Partner with external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/advocates).
  • Support trial-level statistical analysis plan, TLFs, database release; review IIR proposals.

Basic Qualifications

  • Education: MD or DO.
  • Experience: chronic weight management/endocrinology/internal medicine; Phase 1–3 clinical development and translational medicine; 8+ years in clinical R&D (academia and/or biopharma).
  • Extensive knowledge of global/regional regulation, ICH/GCP, adverse event management.
  • Demonstrated medical/administrative/project management; effective verbal/written communication; manage/train large teams (designing/launching large teams preferred).

Competencies (required)

  • Leadership, influence in matrix environments, accountability, conflict management, team building, and ability to deliver amid change.

Benefits/Compensation (as stated)

  • Base salary range: $274,500–$457,500; bonus target 25%; eligibility for long-term incentive; 401(k) with matching and additional retirement contribution; paid vacation/holiday/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision.

Work

  • 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 san diego at Unknown Company

This position is listed as full time and hybrid.

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