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BioAge Labs is seeking a Director of Clinical Science to provide scientific and clinical leadership for Phase 1–3 clinical trials, including first-in-human studies. Reporting to the Senior Director of Clinical Science, this role oversees protocol development, medical monitoring activities, patient safety review, and day-to-day clinical study execution to advance the company's clinical development programs.
Key responsibilities include supporting medical monitoring activities such as review of subject eligibility, protocol deviations, adverse events, concomitant medications, laboratory results, ECGs, and other clinical data to ensure participant safety and data integrity. The Director will review prospective patient eligibility and provide clinical guidance to investigators regarding enrollment decisions and protocol interpretation.
The role involves contributing to protocol design, statistical analysis plans, clinical study reports, and investigator brochures; designing pharmacokinetic sampling schedules. The Director will author and review clinical sections of INDs/CTAs, briefing books, meeting requests, and marketing applications, and participate in FDA/EMA interactions.
Additional duties include integrating nonclinical, translational, biomarker, and clinical data to inform decisions; providing clinical pharmacology oversight of ongoing clinical trials; collaborating with investigators and study sites to address protocol-related questions; leading the development, review, and amendment of clinical study protocols, investigator brochures, informed consent forms, and medical monitoring plans; and partnering with Pharmacovigilance to review safety events and assess safety signals.
This is a fully remote position available to candidates in any continental US state. The role requires deep expertise in clinical trial management, regulatory affairs, and clinical pharmacology within the biotech/pharma space.
