Director, Clinical Development Sciences

Your Role

• Provide input to key research activities for a specific study/program, including clinical trial design, conduct, analysis, reporting, and study start‑up (training materials, site identification, and site visits)
• Contribute to the development of the medical review plan, Independent Review Charter (IRC), and related program documents
• Perform medical review, assessment, and interpretation of clinical trial data with cross‑functional teams during trial conduct and in the clinical study report (CSR) to ensure accuracy and appropriate medical/scientific interpretation
• Review and track emerging efficacy and safety; keep the study team informed and take appropriate action
• Attend and contribute to study management, data management committee, cross‑functional data review, clinical development team, IND/pre‑IND, and regulatory submission planning meetings
• Assist eCRF design, perform clinical user acceptance testing, and collaborate with data management/statistics for eCRF and database set‑up
• Support medical writing across a program (e.g., Regulatory Briefing Books, protocol summary and full protocol, Investigator Brochure updates, IND clinical sections, CSR/NDAs sections, IRB/health authority/ethics committee responses)
• Ensure compliance with GCP, internal SOPs, local regulations, and laws

• Advanced scientific degree (e.g., NP, PharmD, MS, MPH, PhD, DDS) or equivalent plus 7+ years clinical research experience in pharma/biotech clinical development; significant focus on oncology therapeutics
• Understanding of IND‑to‑NDA development process (clinical study design, data management, clinical operations, regulatory, and medical writing)
• Experience developing FDA/regulatory review documents (briefing books, end‑of‑phase meetings, INDs, NDAs)
• Knowledge of GCP and regulatory requirements for oncology trials
• Proficiency in Microsoft Office; eCRF tools (e.g., Medidata Rave) and data review tools (e.g., J‑review)

• Knowledge of preclinical/translational sciences
• Experience with heme‑onc indications
• Experience in first‑in‑human trials, protocol development, medical review, trial oversight, key stakeholder engagement, data quality, safety, and/or medical writing

Base pay range: $–$ annually (varies by factors such as knowledge, skills, and experience)