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

Your Background
Required:
- 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)

Preferred:
- 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

Compensation
- Base pay range: $221,935.00–$245,295.00 annually (varies by factors such as knowledge, skills, and experience)