Global Development Lead, Internal Medicine (Sr. Director)

Scorpion Therapeutics; San Diego (CA); Hybrid; USD 215,000 - 358,000; Full time

Job summary

Scorpion Therapeutics seeks an accomplished Clinical Development leader to design, execute, and interpret studies for worldwide regulatory submissions. This role will partner with trial clinicians to create the Clinical Development Plan and protocol designs across the study lifecycle.

You will lead global development planning for approval and reimbursement, with exposure to pediatric considerations and product profiles, while guiding external stakeholders and ensuring regulatory compliance.

Qualifications

• BS with 12+ years or PhD with 7+ years in clinical/biotech R&D.
• Experience leading cardiometabolic late-stage programs.
• Knowledge of global/regional regulation, ICH/GCP.
• Ability to lead large cross-functional teams.

Responsibilities

• Design, execute, and interpret studies for worldwide regulatory submissions.
• Create and endorse Clinical Development Plan and study protocols; partner with trial clinicians across the lifecycle.
• Lead development planning for approval and reimbursement globally (incl. China/Japan).
• Provide therapy area expertise and input to target product profiles.
• Develop submission-level deliverables and support safety narratives.

Skills

Medical leadership

Team leadership

Regulatory strategy

Stakeholder engagement

Education

BS/PhD with 7+ years clinical/industry

Job description

Responsibilities

• Lead cross-functional Clinical Development Team to design, execute, and interpret studies for worldwide regulatory submissions.
• Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; partner with trial clinicians across study lifecycle.
• Lead development planning for approval and reimbursement globally (incl. China/Japan), including pediatric investigation plan/study plan and pediatric protocol documents.
• Provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization) and input to target product profiles.
• Develop clinical development enabling strategies (digital/innovation, patient engagement).
• Partner in governance reviews; contribute category clinical development strategy input.
• Support trial-level statistical analysis plan, TLFs, table-listings-figures, and database release (with statistics/programming).
• Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; support label development/maintenance.
• Lead/review submission safety narrative plan; provide regulatory submission support (DSUR, PBRER) and product defense.
• Engage external stakeholders (e.g., ad boards, steering committees, DMC, adjudication committees, patients).
• Ensure compliance with internal SOPs and external regulatory standards.

Basic Qualifications

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

Experience

• Lead cardiometabolic late-stage programs (incl. type 2 diabetes).
• Track record of success in academia and/or biopharma clinical R&D.
• Knowledge of global/regional regulation, ICH/GCP, adverse event management.
• Manage/train large clinical teams; experience designing/launching large teams preferred.

Key Skills/Competencies (required)

• Medical/scientific excellence; strong management and leadership in matrix environments.
• Effective influencing, conflict management, team building, accountability, and agility in uncertainty.

Non-standard/Env

• Up to 30% travel; hybrid (on-site ~2.5 days/week). Relocation support available.

Compensation/Benefits (if hired)

• Base salary range: $214,900–$358,100 (U.S. range; Tampa, FL differs).
• Bonus target 22.5% of base.
• Participation in share-based long-term incentives.
• 401(k) match.
• Paid vacation/holidays.
• Caregiver/parental and medical leave.
• Medical/dental/vision coverage.