Global Development Lead, Internal Medicine (Sr. Director)

Scorpion Therapeutics; Pearl River (NY); On-site; USD 180,000 - 320,000; Full time

Job summary

Scorpion Therapeutics is seeking a senior Clinical Development leader to oversee cross-functional teams for assigned assets, guiding study design, execution and interpretation to support worldwide regulatory submissions.

You will partner with the Product Team Lead to align milestones, manage timelines and budgets, provide therapeutic area expertise, and drive regulatory strategies including DSUR/PBRER, submission safety narratives, and product defense.

Qualifications

• Lead cardiometabolic late-stage development programs (including type 2 diabetes).
• Track record in academia and/or biopharmaceutical industry clinical R&D; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
• Demonstrated project/admin management, strong verbal/written communication, and ability to manage/train large clinical development teams.

Responsibilities

• Lead cross-functional Clinical Development Team for assigned asset(s); oversee design, execution, and interpretation of studies supporting worldwide regulatory submissions.
• Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; ensure trial feasibility and optimized operational execution.
• Partner with the Prod Team Lead to negotiate tradeoffs, milestones, and deliver the clinical program within timelines and budget.
• Provide therapy area/indication expertise for clinical data review (e.g., CRF design, signal interpretation, adverse event contextualization).
• Contribute to statistical analysis and trial deliverables (TFLs, table-listings-figures, database releases).
• Lead submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission safety narrative plan.
• Support product label development/maintenance.
• Provide regulatory submission support (DSUR, PBRER) and product defense.
• Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/advocates) to inform clinical development strategy.

Job description

Role Summary / Responsibilities:

• Lead cross-functional Clinical Development Team for assigned asset(s); oversee design, execution, and interpretation of studies supporting worldwide regulatory submissions.
• Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; ensure trial feasibility and optimized operational execution.
• Partner with the Prod Team Lead to negotiate tradeoffs, milestones, and deliver the clinical program within timelines and budget.
• Provide therapy area/indication expertise for clinical data review (e.g., CRF design, signal interpretation, adverse event contextualization).
• Contribute to statistical analysis and trial deliverables (TFLs, table-listings-figures, database releases).
• Lead submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission safety narrative plan.
• Support product label development/maintenance.
• Provide regulatory submission support (DSUR, PBRER) and product defense.
• Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/advocates) to inform clinical development strategy.

Basic Qualifications:

• BS with 12 years or PhD with 7 years relevant clinical/industry experience.

Experience / Requirements:

• Lead cardiometabolic late-stage development programs (including type 2 diabetes).
• Track record in academia and/or biopharmaceutical industry clinical R&D; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
• Demonstrated project/admin management, strong verbal/written communication, and ability to manage/train large clinical development teams.

Competency:

• Matrix leadership and influencing; conflict management; accountability; ability to operate in uncertainty.

Preferred/Additional:

• Experience designing/launching large teams.