Global Clinical Development Lead, CardioMetabolic – Hybrid

Scorpion Therapeutics; Cambridge (MA); Hybrid; USD 230,000 - 320,000; Full time

Benefits offered by this job

Relocation support

Job summary

Scorpion Therapeutics in Cambridge, MA is seeking a Global Development Lead (GDL) to serve as the single clinical point of accountability for clinical development of assigned Internal Medicine assets. You will lead a cross-functional Clinical Development Team to design, execute, and interpret studies for worldwide regulatory submissions and develop the Clinical Development Plan and protocol designs.

Travel up to 30% and relocation support available.

Qualifications

• BS with 12 years or PhD with 7 years relevant clinical/industry experience.
• Experience leading cardiometabolic late-stage development (including type 2 diabetes).
• Strong track record in academia and/or biopharma clinical R&D.
• Extensive knowledge of clinical development, global regulation, ICH/GCP, and adverse event management.
• Demonstrated clinical, administrative, and project management skills; strong verbal and written communication.
• Demonstrated ability to manage and train large clinical development teams (and design/launch large teams preferred).

Responsibilities

• Partner with the Prod Team Lead to negotiate tradeoffs, milestones, and ensure clinical program delivery within timelines and budget.
• Develop comprehensive clinical development plan to secure global approval and reimbursement (including China and Japan), including pediatric investigation/study plan and protocol design.
• Provide input for target product profiles; deliver clinical development enabling strategies (digital/innovation and patient engagement).
• Partner with trial clinicians on governance reviews; provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization).
• Support statistical analysis plan, TLFs/table-listings-figures, and database release.
• Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan.
• Support product label development/maintenance; engage external stakeholders (Ad boards, steering committees, DMC, adjudication committees, patients).
• Provide regulatory submission support (DSUR, PBRER), product defense, and ensure compliance with SOPs and regulatory standards.

Skills

Cardiometabolic development leadership

Clinical R&D expertise

ICH/GCP regulatory knowledge

Team leadership

Communication skills

Education

BS with 12 years experience

PhD with 7 years experience

Job description

Scorpion Therapeutics in Cambridge, MA is seeking a Global Development Lead (GDL) to serve as the single clinical point of accountability for clinical development of assigned Internal Medicine assets. You will lead a cross-functional Clinical Development Team to design, execute, and interpret studies for worldwide regulatory submissions and develop the Clinical Development Plan and protocol designs.

Travel up to 30% and relocation support available.