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Global Development Lead, Internal Medicine; Sr. Director
Job in
Pittsburgh, Allegheny County, Pennsylvania, 15289, USA
Listed on 2026-08-30
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-08-30
Job specializations:
-
Science
Clinical Research
Job Description & How to Apply Below
Responsibilities:
- Lead cross-functional Clinical Development Team for assigned Internal Medicine/R&D assets; design, execute, and interpret studies supporting worldwide regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and associated protocol design documents; ensure delivery aligned to timelines/budget.
- Accountable for clinical development plan for global approval/reimbursement (incl. China/Japan) and pediatric investigation plan/study plan.
- Provide product/program input for target product profiles; drive innovative/bold clinical development decisions.
- Develop enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews and provide category/therapy-area expertise (CRF design, signal interpretation, adverse event contextualization).
- Support trial-level statistical analysis plan, TLFs/table-listings-figures, and database release (with statistics/programming).
- Develop submission deliverables (IAP/IARP/submission TLFs) including SCE/SCS; review/approve submission safety narrative plan; support label development/maintenance.
- Support regulatory submission deliverables (DSUR, PBRER) including product defense; ensure compliance with SOPs and regulatory standards.
- BS with 12 years or PhD with 7 years relevant clinical/industry experience.
- Experience leading cardiometabolic late-stage development (incl. type 2 diabetes); success in academic and/or biopharma clinical R&D.
- Deep knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
Skills:
- Proven ability to manage/train large teams; demonstrated leadership in designing/launching large teams.
- Strong verbal/written communication; influence in complex matrix environments; accountability and conflict management.
- Relocation support
- bonus target 22.5% and access to long-term incentive
- comprehensive health, paid leave, and 401(k) with company match (plus additional retirement contribution)
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