Global Development Lead, Internal Medicine (Sr. Director)

Scorpion Therapeutics; Lake Forest (IL); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Global Development Lead to serve as the single clinical accountability for development programs. You will design and guide cross-functional teams, ensure alignment with regulatory submissions, and own global development plans with pediatric considerations as needed.

Responsibilities include planning, budget and timeline governance, and collaboration with trial clinicians to inform strategy and data interpretation. A strong therapeutic area expertise is essential.

Qualifications

• Bachelor-level or above with substantial clinical development experience.
• Doctoral degree with extensive industry experience preferred.

Responsibilities

• Create and endorse the Clinical Development Plan and protocol designs.
• Lead cross-functional clinical development delivery to timelines and budget.

Education

BSc with 12 years

PhD with 7 years

Job description

Role Summary:

The Global Development Lead (GDL) is the single clinical point of accountability for clinical development for assigned asset(s). Leads cross-functional clinical development team design, execution, and interpretation of studies supporting worldwide regulatory submissions.

Responsibilities:

• Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
• Lead clinical program delivery in line with timelines and budget; negotiate tradeoffs with the Prod Team Lead.
• Own global clinical development plan for approval and reimbursement; develop pediatric investigation/study plan and protocol documents.
• Provide input for target product profile(s) and regulatory activities (product labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
• Partner with trial clinicians on governance (Sci/Ops) and provide category strategy input.
• Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event context).
• Support trial-level statistical analysis plan and TLF/database release with statistics/programming.
• Develop submission-level deliverables (IAP, IARP, submission TLFs; SCE and SCS); review/approve submission safety narrative plan.
• Support product label development/maintenance and communication of clinical trial data.
• Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients) to inform clinical strategy and PDD development.
• Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.

Basic Qualifications:

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

Experience:

• Leading cardiometabolic late-stage development (including type 2 diabetes).
• Track record of success in academia and/or biopharma clinical R&D.
• Deep knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
• Demonstrated clinical/medical, administrative, and project management; strong written/verbal communication.
• Experience managing/training large clinical development teams; experience designing/launching large teams preferred.

Competency Requirements (skills):

• Medical/scientific credibility; leadership; matrix influence; conflict management; team building; accountability; agility in uncertainty; ability to influence/collaborate, coach others, and oversee colleagues’ work.

Non-standard work/travel:

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