Senior Global Clinical Development Lead — Lead Global Programs & Pediatric Plans

Scorpion Therapeutics

Pearl River (NY)

Hybrid

USD 180,000 - 240,000

Full time

14 days+
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Benefits offered by this job

Bonus target 22.5%
401(k) match
Paid time off
Caregiver/ parental leave
Medical/dental/vision

Job summary

Scorpion Therapeutics is seeking a Senior leader to own clinical development for Internal Medicine assets, guiding cross-functional teams to design, execute, and interpret pivotal studies for global regulatory submissions.

You will lead pediatric plans, review clinical data, and contribute to product profiles and regulatory documents while ensuring compliance with ICH/GCP and internal SOPs. Hybrid travel up to 30% expected.

Qualifications

  • PhD or PharmD required.
  • 8+ years clinical R&D experience including Ph1–3 development and translational medicine.
  • Background in obesity, endocrinology, or internal medicine.
  • Extensive knowledge of global/regional regulation, ICH/GCP, and adverse event management.
  • Proven leadership, administrative and project management capabilities.

Responsibilities

  • Lead clinical development accountability for assigned Internal Medicine asset(s); represent Clinical on Global Medicine Team.
  • Build and gain endorsement for Clinical Development Plan and protocol designs.
  • Lead cross-functional Clinical Development Team for study design, execution, and interpretation supporting global regulatory submissions.
  • Develop pediatric investigation/study plan and protocol design; ensure feasibility and optimized execution.
  • Provide therapy area expertise for clinical data review (CRF design, signal interpretation, AE contextualization).
  • Contribute to target product profiles and regulatory activities (labels, core data sheets, Investigator Brochures, DSUR, PBRER).
  • Partner on trial-level statistical analysis plans, TLFs/table-listings-figures, and database release.
  • Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan.
  • Support label development/maintenance; engage external stakeholders (ad boards, Steering Committees, DMC, adjudication, patients/advocates).
  • Ensure compliance with internal SOPs and external regulatory standards.
  • May assume additional Obesity portfolio clinical leadership; may provide specialized medical monitoring if required.

Skills

Clinical development
Leadership
Regulatory knowledge
Communication

Education

PhD
PharmD

Job description

Scorpion Therapeutics is seeking a Senior leader to own clinical development for Internal Medicine assets, guiding cross-functional teams to design, execute, and interpret pivotal studies for global regulatory submissions.

You will lead pediatric plans, review clinical data, and contribute to product profiles and regulatory documents while ensuring compliance with ICH/GCP and internal SOPs. Hybrid travel up to 30% expected.

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