Senior Director, Clinical Development

Role Summary

Senior Director, Clinical Development to lead clinical strategy and execution for the company’s ADC and radioligand therapy portfolio across all development stages.

Responsibilities

• Lead and execute the clinical development strategy for novel oncology therapies.
• Collaborate with internal and external stakeholders to design and implement a clinical development plan across indications.
• Author/lead key clinical trial documents and clinical sections of regulatory filings such as pre-INDs and INDs.
• Serve as the primary Medical Monitor for assigned programs, including overseeing internal and external teams and providing medical guidance to CRO partners and clinical sites.
• Support safety monitoring and pharmacovigilance activities.
• Collaborate cross-functionally with clinical operations, regulatory, project management, manufacturing, and business development to define timelines, manage risks, and ensure milestone delivery.
• Work closely with translational sciences to integrate key biomarker and pharmacodynamic endpoints into clinical study designs.
• Establish and maintain strong relationships with PIs, KOLs and other external stakeholders.
• Review, assess, interpret, and communicate clinical trial data to internal stakeholders and external partners.
• Lead clinical trial data publication efforts.
• Facilitate key meetings such as advisory boards, safety review committees, investigator meetings.

Qualifications

• Required: M.D., D.O. or equivalent.
• Preferred: Board certification in medical oncology or hematology.
• Required: A minimum of 2-4+ years of experience leading Clinical Development and Phase 1–3 oncology clinical trials in a biotech or pharmaceutical setting.

Skills

• Proven experience advancing therapeutic programs from IND-enabling studies through early and late-stage clinical development.
• Understanding of FDA and EMA regulatory requirements and successful track record in regulatory interactions.
• Demonstrated leadership and ability to effectively manage cross-functional teams.