Clinical Development Executive Medical Director

Scorpion Therapeutics; Cambridge (MA); Hybrid; USD 260,000 - 360,000; Full time

Benefits offered by this job

Hybrid work location

Job summary

Scorpion Therapeutics is seeking a Clinical Development Executive Medical Director in the GU Therapeutic Area to define and execute the development strategy for Enfortumab vedotin. The role leads the global development plan, harmonizing regulatory, statistical, and stakeholder input to deliver trials and product milestones.

The candidate will manage a diverse team, oversee regulatory submissions, and provide governance for safety and pharmacology decisions, including preparation for regulatory

Qualifications

• Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
• 7+ years industry experience.
• 5+ years leading diverse teams.
• Prior management responsibilities for medical directors or clinical scientists.

Responsibilities

• Lead, develop, and execute the clinical development plan for Enfortumab vedotin across the Global Development Team, aligned to lifecycle and integrated product plans.
• Own clinical development strategy, trial design, execution, and trial results delivery.
• Integrate regulatory, statistical, and stakeholder input into study designs.
• Lead product-specific Global Development Team; serve as clinical subject matter expert.
• Provide clinical governance support (endorse decisions ahead of reviews/governance).
• Oversee medical director(s); serve as primary interface with the Development Review Committee.
• Oversee clinical protocols/amendments, investigator brochures, and clinical study reports.
• Oversee evaluation, interpretation, reporting, presentation, and publication of study data.
• Accountable for safety decisions and clinical pharmacology input (optimal dose/schedule).
• Lead preparation of clinical content for regulatory submissions (e.g., NDA/MAA/IND/sNDA, IB, AR/DSRU, label changes, Core Data Sheet, Package Insert).
• Provide clinical input for health authority meetings; lead regulator discussions and regulatory query responses.
• Support business development/due diligence via protocol design/conduct/review as appropriate.

Skills

Leadership

Clinical trial design

Regulatory strategy

Team management

Education

Medical degree (MD/DO) or equivalent

Job description

ROLE SUMMARY

This position is for a Clinical Development Executive Medical Director within the GU Therapeutic Area, responsible for defining and executing the development strategy of Enfortumab vedotin.

ROLE RESPONSIBILITIES

• Lead, develop, and execute the clinical development plan for Enfortumab vedotin across the Global Development Team, aligned to lifecycle and integrated product plans.
• Own clinical development strategy, trial design, execution, and trial results delivery.
• Integrate regulatory, statistical, and stakeholder input into study designs.
• Lead product-specific Global Development Team; serve as clinical subject matter expert.
• Provide clinical governance support (endorse decisions ahead of reviews/governance).
• Oversee medical director(s); serve as primary interface with the Development Review Committee.
• Oversee clinical protocols/amendments, investigator brochures, and clinical study reports.
• Oversee evaluation, interpretation, reporting, presentation, and publication of study data.
• Accountable for safety decisions and clinical pharmacology input (optimal dose/schedule).
• Lead preparation of clinical content for regulatory submissions (e.g., NDA/MAA/IND/sNDA, IB, AR/DSRU, label changes, Core Data Sheet, Package Insert).
• Provide clinical input for health authority meetings; lead regulator discussions and regulatory query responses.
• Support business development/due diligence via protocol design/conduct/review as appropriate.

BASIC QUALIFICATIONS

• Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
• 7+ years industry experience.
• 5+ years leading diverse teams.
• Prior management responsibilities for medical directors or clinical scientists.

PREFERRED QUALIFICATIONS

• Board certified/eligible in oncology (or equivalent).
• Experience across multiple clinical phases and oncology drug classes.
• Experience leading NDA/BLA/MAA.

OTHER

• Ability to travel globally as needed; may require work outside typical hours.
• Hybrid work location.