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

Scorpion Therapeutics; Pearl River (NY); Hybrid; USD 180,000 - 240,000; Full time

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

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 associated protocol design documents.


• Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) 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/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).


• Contribute to target product profile(s) and regulatory activities (labels, core data sheets, Investigator Brochures, DSUR, PBRER).


• Partner on trial-level statistical analysis plan, 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 (e.g., 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.

Qualifications / Required

• PhD or PharmD.


• 8+ years clinical R&D experience; Ph1–3 clinical development and translational medicine.


• Background in chronic weight management/endocrinology/internal medicine.


• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.


• Demonstrated clinical/medical, administrative, and project management; strong written/verbal communication.

Preferred / Additional

• Demonstrated experience managing/training large teams; designing and launching large teams.

Skills / Competencies

• Clinical/scientific credibility; ability to coordinate clinical lifecycle strategy.


• Leadership and influence in a complex matrix; conflict management; accountability; ability to deliver amid change.

Work requirements

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

Benefits (explicitly stated)

• Participation in Global Performance Plan (bonus target 22.5%) and eligibility for share-based long-term incentives; comprehensive benefits including 401(k) match, paid time off, caregiver/parental leave, and medical/dental/vision.