Associate Director / Director, Clinical Development

Responsibilities

• Provide medical monitoring oversight for oncology clinical trials, including review of safety events, eligibility questions, dose modifications, protocol deviations, laboratory abnormalities, and emerging clinical data.
• Serve as the primary medical point of contact for investigators, study sites, CRO medical monitors, and internal cross-functional teams.
• Support safety monitoring and pharmacovigilance activities, including review and medical input on adverse events, suspected unexpected serious adverse reactions, and other clinically significant safety findings.
• Collaborate with internal and external stakeholders to design and implement a clinical development plan across indications.
• Author key clinical trial documents and clinical sections of regulatory filings such as protocols, pre-INDs, IND/CTAs, Investigator Brochures, briefing documents, and BLAs.
• 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.
• Lead or contribute to key external meetings such as advisory boards, safety review committees, investigator meetings, and site trainings.
• Support quality initiatives related to clinical trial conduct, as needed.

Qualifications

• M.D., D.O., or equivalent.
• Board certification in medical oncology or hematology preferred.
• A minimum of 1 year of experience in Clinical Development and Phase 1 – 3 oncology clinical trials in a biotech or pharmaceutical setting, or equivalent.

Skills

• Proven experience advancing therapeutic programs in early or late-stage clinical development.
• Understanding of FDA and other health authority regulatory requirements and successful track record in regulatory interactions.
• Demonstrated leadership and ability to effectively manage cross-functional teams.
• Excellent written and verbal communication skills, with the ability to communicate complex medical and scientific information clearly to diverse audiences.
• Strong organizational skills and ability to manage multiple studies, priorities, and timelines in a fast-paced biotech environment.
• High attention to detail, sound clinical judgment, and strong commitment to patient safety and data quality.