Director, Clinical Science

Bio Age Labs (BIOA) is finding new ways to treat disease by targeting the mechanisms of aging, with the ultimate goal of increasing healthy human lifespan.

We are seeking an experienced Director, Clinical Science. This is a fully remote position, and the successful candidate can live in any of the continental US states.

Reporting to the Senior Director, Clinical Science, the Director of Clinical Science provides scientific and clinical leadership for Phase 1–3 clinical trials, including first-in-human studies, overseeing protocol development, medical monitoring activities, patient safety review, and day-to-day clinical study execution to advance Bio Age’s clinical development programs.

Clinical trial planning and conduct

• Support the physician lead in ongoing medical monitoring activities, including review of subject eligibility, protocol deviations, adverse events, concomitant medications, laboratory results, ECGs, and other clinical data to ensure participant safety and data integrity.
• Review prospective patient eligibility and provide clinical guidance to investigators regarding enrollment decisions and protocol interpretation.
• Contribute to protocol design, statistical analysis plans, clinical study reports, and investigator brochures; design PK sampling schedules.
• Author/review clinical sections of INDs/CTAs, briefing books, meeting requests, and marketing applications; participate in FDA/EMA interactions.
• Integrate nonclinical, translational, biomarker, and clinical data to inform decisions.
• Provide clinical pharmacology oversight of ongoing clinical trials, ensuring subject safety, protocol compliance, and high-quality study conduct.
• Collaborate with investigators and study sites to address protocol-related questions and provide timely scientific and clinical guidance throughout study conduct.
• Lead the development, review, and amendment of clinical study protocols, investigator brochures, informed consent forms, medical monitoring plans, and other clinical documents.
• Partner with Pharmacovigilance to review safety events, assess safety signals, and contribute to safety monitoring committees and data review meetings.
• Work cross-functionally with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Program Management to support clinical development, trial start-up, day-to-day management of ongoing trials, and trial closeout.
• Contribute to the preparation of clinical study reports, regulatory submissions, investigator meeting materials, abstracts, manuscripts, and presentations.

• Develop and execute the clinical pharmacology strategy across programs; own dose selection, optimization and justification (FIH starting dose through registrational dose).
• Provide input on DDI, food effect, hepatic/renal impairment, QT/QTc, and special-population dosing.
• Conduct or oversee NCA, population PK, exposure–response, PBPK, and mechanistic PK/PD analyses to support development decisions and regulatory interactions — either hands‑on or in collaboration with quantitative scientists/vendors.
• Oversee PK sample strategy, bioanalytical assay development/validation and sample testing at external labs; manage CRO/pharmacometrics vendor deliverables and quality.

• Doctor of Pharmacy (PharmD) or equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, or a related discipline required.

• Active pharmacist or medical licensure is preferred but not required.

• 5+ years of progressive experience in clinical drug development within the pharmaceutical or biotechnology industry.

• Experience serving as a Clinical Scientist, Clinical Development Scientist, or equivalent role…