Director, Clinical Science

BioAge Labs

3h • $230,000 - $250,000 • Remote

About The Position

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 BioAge's clinical development programs.

Requirements

• Doctor of Pharmacy (PharmD) or equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, or a related discipline 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 supporting Phase 1–3 clinical trials including supporting medical monitoring.
• Experience authoring bioanalytic reports, clinical protocols, protocol amendments, clinical study reports, and regulatory submission documents.
• Experience interacting with investigators, CROs, and cross-functional clinical development teams.
• Experience supporting regulatory interactions and health authority submissions.
• Demonstrated expertise in clinical drug development, including protocol design, medical monitoring, safety data review, and clinical trial execution across Phase 1–3 studies.
• Experience interpreting clinical, laboratory, pharmacokinetic, pharmacodynamic, and safety data to support ongoing clinical development.
• Proven ability to provide day-to-day clinical support to investigators and study teams, including protocol interpretation, subject eligibility review, and management of clinical trial questions.
• Excellent scientific writing skills with experience authoring and reviewing clinical protocols, investigator brochures, clinical study reports, and regulatory documents.
• Demonstrated ability to collaborate effectively across Clinical Operations, Pharmacovigilance, Biostatistics, Data Management, Regulatory Affairs, Translational Sciences, and Program Management.
• Excellent communication and presentation skills with the ability to communicate complex clinical information to internal and external stakeholders.
• Ability to manage multiple clinical programs in a fast-paced biotechnology environment.

Nice To Haves

• Active pharmacist or medical licensure is preferred but not required.
• Modeling software proficiency is a plus: NONMEM, Phoenix WinNonlin, Monolix, R (± Simcyp/GastroPlus/Python), or other PBPK platforms.
• Prior experience in a clinical-stage biotechnology company is highly desirable.

Responsibilities

• 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.

Benefits

• competitive salary
• comprehensive compensation package
• generous paid time off
• company-observed holidays
• comprehensive health and wellness benefits (medical, dental, and vision insurance)
• 401(k) retirement savings plan with matching employer contributions
• childcare benefits
• fertility benefits
• opportunities for career development
• generous annual budget for continued learning
• dedication to training and skill development

What This Job Offers

• Job Type: Full-time
• Career Level: Director