Senior Director, Clinical Development

Position summary:  

We are seeking an accomplished Senior Director, Clinical Development to join our passionate and collaborative team and drive the advancement of our pipeline of targeted cancer therapies. In this high-impact role, you will lead clinical strategy and execution within our innovative portfolio of ADC and radioligand therapies across all stages of development. 

Key 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:  

• M.D., D.O. or equivalent. Board certification in medical oncology or hematology preferred.   

• A minimum of 2-4+ years of experience leading Clinical Development and Phase 1 – 3 oncology clinical trials in a biotech or pharmaceutical setting.   

Knowledge and 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