Clinical Development Executive Medical Director

Scorpion Therapeutics; Pennsylvania; On-site; USD 250,000 - 350,000; Full time

Job summary

Scorpion Therapeutics in the United States seeks a senior clinical development leader to own the Enfortumab vedotin development plan, aligning with lifecycle and integrated product strategy. You will design trials, oversee execution, and deliver robust trial results while integrating regulatory, statistical, and stakeholder input.

You will lead the Global Development Team, oversee safety decisions and pharmacology, prepare regulatory submissions, and collaborate with health authorities.

Qualifications

• Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
• 7+ years industry experience.
• 5+ years experience leading diverse teams.

Responsibilities

• Lead, develop, and execute the clinical development plan for Enfortumab vedotin in alignment with the Lifecycle Management Plan and Integrated Product Plan.
• Own clinical development strategy, trial design, execution, and delivery of trial results.
• Integrate regulatory, statistical, and stakeholder input into study designs.
• Lead the product-specific Global Development Team; serve as clinical subject matter expert.
• Endorse clinical development decisions prior to GPT/senior management/governance reviews.
• Provide oversight/management for 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.
• Own safety decisions and clinical pharmacology for optimal dose/schedule selection.
• Lead clinical content preparation for regulatory submissions/documents (e.g., NDA/MAA/IND/sNDA, IB, AR/DSRU, label/Core Data Sheet/Package Insert).
• Provide clinical input for meetings with health authorities and regulatory query responses.
• Support business development initiatives as appropriate (e.g., due diligence protocol design/conduct/review).

Skills

Clinical development leadership

Trial design & execution

Regulatory strategy

Team leadership

Cross-functional collaboration

Oncology drug development

Global project leadership

Education

Medical degree or advanced degree in relevant field

Job description

Role Responsibilities

• Lead, develop, and execute the clinical development plan for Enfortumab vedotin in alignment with the Lifecycle Management Plan and Integrated Product Plan.
• Own clinical development strategy, trial design, execution, and delivery of trial results.
• Integrate regulatory, statistical, and stakeholder input into study designs.
• Lead the product-specific Global Development Team; serve as clinical subject matter expert.
• Endorse clinical development decisions prior to GPT/senior management/governance reviews.
• Provide oversight/management for 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.
• Own safety decisions and clinical pharmacology for optimal dose/schedule selection.
• Lead clinical content preparation for regulatory submissions/documents (e.g., NDA/MAA/IND/sNDA, IB, AR/DSRU, label/Core Data Sheet/Package Insert).
• Provide clinical input for meetings with health authorities and regulatory query responses.
• Support business development initiatives as appropriate (e.g., due diligence protocol design/conduct/review).

Basic Qualifications

• Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
• 7+ years industry experience.
• 5+ years experience 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, or MAA.

Other

• Ability to travel globally as needed; may work outside typical hours.
• Individual contributor or management responsibility for 1-6 Associate Medical Directors/Medical Directors/Senior Medical Directors.
• Reports to Therapeutic Area Head.