Support day-to-day medical monitoring, clinical development, data services, and pharmacovigilance for lead programs
Collaborate cross-functionally with Clinical Operations, Regulatory, Biometrics, Translational Sciences, and Medical teams to ensure high-quality and timely study execution
Perform ongoing review and interpretation of clinical data, including safety, efficacy, and longitudinal patient data
Act as a primary contributor and owner of key clinical deliverables, including: Clinical study protocols, Investigator’s Brochures, Clinical study reports, and Regulatory submission documents
Support clinical trial conduct and oversight, including data review, issue identification, and resolution
Contribute to regulatory interactions and submissions, including preparation of FDA-facing materials and global regulatory documentation
Partner with Clinical Operations to support patient enrollment strategy and execution

Advanced degree required: PharmD, PhD, or MS in a health or life sciences field
3–6+ years of experience in clinical development within biotech or pharma, preferably in a Clinical Scientist or similar role
Experience in oncology, hematology, and/or cell and gene therapy strongly preferred
Demonstrated experience authoring and contributing to: Clinical protocols and amendments, Investigator’s Brochures, and Regulatory submission documents and clinical datasets
Strong understanding of clinical trial design, execution, and data interpretation
Ability to independently analyze complex clinical data and communicate insights clearly
Comfortable operating in a hands-on, execution-focused role with high ownership of deliverables
Strong cross-functional collaboration skills in a fast-paced, matrixed environment
Experience supporting IND submissions and/or global regulatory activities preferred
Ability and interest to grow into a leadership role as the clinical team expands

Director, Clinical Scientist

Key skills