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.
Position Summary: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.
Job Duties: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.
Clinical pharmacology
- 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.
Required Education & Experience- 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 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.
Required Qualifications- 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 te
- 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.
Other Qualifications:- Modeling software proficiency is a plus: NONMEM, Phoenix WinNonlin, Monolix, R (± Simcyp/GastroPlus/Python), or other PBPK platformsams, including protocol interpretation, subject eligibility review, and management of clinical trial questions.
- Prior experience in a clinical-stage biotechnology company is highly desirable.
Our workplaceBioAge offers competitive salary, a comprehensive compensation package, and generous paid time off in addition to company-observed holidays. We provide comprehensive health and wellness benefits (medical, dental, and vision insurance) and a 401(k) retirement savings plan with matching employer contributions, and we support families through childcare and fertility benefits. We also pride ourselves in giving employees many opportunities for career development, including a generous annual budget for continued learning and a dedication to training and skill development. Many positions (including this one) are remote, allowing our team members to work from anywhere. The salary for this role is expected to be approximately $230,000 - $250,000, depending on experience. We are open to the concept that different experience levels add value to the team in different ways, and therefore will consider a variety of experience and offer commensurate pay.
