Director, Clinical Science

Director, Clinical Science

Responsibilities:

• Partner with medical monitor(s) in study oversight, data review/interpretation for assigned programs (initially PiNACLE and PiNACLE-H2H), and pivot as needs evolve.
• Support medical monitor in execution of clinical trials; ensure protocol, regulatory requirements, and GCP adherence.
• Contribute to patient safety monitoring by supporting adverse event management and timely regulatory reporting.
• Collaborate on clinical trial protocol design/development, including endpoints and patient population selection.
• Coordinate cross-functionally to ensure accurate/timely data collection, analysis, reporting; assist with interpretation of clinical/translational data for study decisions.
• Plan/coordinate data cleaning to support analyses for planned publications (abstracts, presentations, manuscripts).
• Support preparation/review of regulatory documents (e.g., IND/BLA): clinical study reports, Investigator’s Brochures, and responses to regulatory questions.
• Collaborate cross-functionally (Clinical Ops, Translational Sciences, Biostatistics, Data Management, Pharmacovigilance, Regulatory, Medical Affairs) and with external stakeholders (investigators, committees, KOLs, CROs), including meetings, site visits, and steering/SMC/DMC activities.
• Identify innovations (including AI) and manage risks with timely recommendations.

Preferred Education:

• PhD, PharmD, PA-C, ARNP, MS, or BSRN in a related field; or relevant scientific/clinical education (e.g., immunology, oncology, molecular biology, healthcare delivery).

Preferred Experience:

• 10+ years delivering results in clinical/research/pharma.
• 4+ years clinical development (7+ years related), ideally oncology focused on cell therapy/T-cell engager/immuno-oncology.
• Demonstrated experience supporting design, execution, and oversight of clinical trials.

Knowledge/Skills:

• Clinical trial design, regulatory submissions, data interpretation; GCP familiarity.
• Strong analytical, organizational, communication skills; ability to manage multiple priorities in a fast-paced environment.

Compensation/Benefits (as stated):

• Salary range: $220,000–$260,000 annually; opportunity for annual bonus; eligibility for Equity Incentive Plan.