Director, Clinical Science

BioAge; Northern (KY); Hybrid; USD 230,000 - 250,000; Full time

Benefits offered by this job

Remote work

Job summary

BioAge Labs seeks an experienced Director, Clinical Science to provide scientific and clinical leadership for Phase 1–3 clinical trials, overseeing protocol development, medical monitoring, patient safety review, and day-to-day study execution to advance BioAge's programs.

Reporting to the Senior Director, the role drives clinical pharmacology oversight, integrates nonclinical and biomarker data, and collaborates with investigators, CROs, and cross-functional teams to ensure high-quality study

Qualifications

• PharmD or equivalent advanced degree required.
• Active pharmacist licensure preferred but not required.
• 5+ years in clinical drug development (Ph1–Ph3).
• Experience authoring regulatory documents and reports.
• Experience with investigators, CROs, and cross-functional teams.
• Experience supporting regulatory submissions.

Responsibilities

• Lead clinical science for Phase 1–3 trials and first-in-human studies.
• Oversee protocol development, medical monitoring, and safety review.
• Collaborate with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Program Management.
• Prepare regulatory submissions and investigator materials; interact with authorities.

Skills

Clinical drug development

Protocol design

Medical monitoring

Safety data review

Clinical trial execution

Scientific writing

Communication & presentation

Program management

Cross-functional collaboration

Education

PharmD or equivalent

Tools

NONMEM

Phoenix WinNonlin

Monolix

R

Python

GastroPlus

Simcyp

Job description

BioAge Labs (BIOA) is finding new ways to treat disease by targeting the mechanisms of aging, with the ultimate goal of increasing healthy human lifespan. https://bioagelabs.com

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 company

BioAge is a clinical-stage biopharmaceutical company harnessing the biology of human aging to develop new therapies for metabolic diseases. The Company’s human-first discovery platform analyzes proprietary multi-omics data captured over decades to identify molecular pathways that drive metabolic aging and disease. BioAge’s lead program, BGE-102, is a potent, orally available, brain-penetrant NLRP3 inhibitor being developed for diseases driven by inflammation. The Company is also advancing oral and injectable APJ agonists—exercise mimetics with the potential to enhance incretin-driven weight loss and restore healthy body composition in obesity. BioAge’s discovery platform is validated by ongoing research collaborations with Novartis and Lilly. BioAge has been listed on Nasdaq (BIOA) since 2024. For additional information about BioAge, visit the company’s website at https://bioagelabs.com.

BioAge 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.

At BioAge, we embrace diversity and differences while we learn from each other, and we believe that every team member has an important role to play. We are an equal opportunity employer. BioAge prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. BioAge conforms to the spirit as well as to the letter of all applicable laws and regulations.