Director, Clinical Science
BioAge Labs
August 13, 2026
Remote
United States
$230,000 - $250,000 USD yearly
Clinical Research and Development
Director, Clinical Science (Fully Remote - continental US)
Position Summary:
- Provide scientific and clinical leadership for Phase 1–3 clinical trials (including first-in-human), overseeing protocol development, medical monitoring, patient safety review, and day-to-day clinical execution.
Responsibilities:
- Support physician lead for medical monitoring: eligibility, protocol deviations, adverse events, concomitant meds, labs, ECGs; ensure participant safety and data integrity.
- Guide investigator enrollment decisions; contribute to protocol and SAP development, clinical study reports, investigator brochures; design PK sampling schedules.
- Author/review clinical IND/CTA sections, briefing books, meeting requests, marketing applications; participate in FDA/EMA interactions.
- Integrate nonclinical/translational/biomarker/clinical data to inform decisions.
- Oversee clinical pharmacology and dose selection/justification; provide input on DDI, food effect, hepatic/renal impairment, QT/QTc, special populations.
- Conduct/oversee NCA, population PK, exposure–response, PBPK, mechanistic PK/PD (hands-on or with scientists/vendors).
- Oversee PK strategy, bioanalytical assay development/validation, CRO/vendor deliverables and quality.
- Lead/maintain protocols and key clinical documents (protocols, amendments, IBs, informed consent forms, medical monitoring plans); partner with Pharmacovigilance on safety signals and safety committees.
- Collaborate cross-functionally (Clinical Ops, Biostatistics, Data Management, Regulatory, Translational, Program Mgmt) for start-up, execution, and closeout.
Required Education & Experience:
- PharmD or equivalent advanced degree in Clinical Pharmacology/Pharmacometrics/related field.
- 5+ years progressive clinical drug development experience.
- Experience supporting Phase 1–3 trials including medical monitoring; authoring clinical/regulatory documents.
Required Qualifications/Skills:
- Expertise in protocol design, medical monitoring, safety review, and Phase 1–3 execution.
- Ability to interpret clinical/lab/PK/PD/safety data.
- Strong scientific writing; collaborate effectively; excellent communication/presentation; manage multiple programs.
Preferred:
- Active pharmacist/medical licensure.
- Modeling software (NONMEM, Phoenix WinNonlin, Monolix, R/Simcyp/GastroPlus/Python, PBPK platforms).
- Prior clinical-stage biotech experience.
Compensation/benefits (stated):
- Salary expected ~$230,000–$250,000 depending on experience; remote work; paid time off and health/401(k) benefits (as listed).
Position Summary:
- Provide scientific and clinical leadership for Phase 1–3 clinical trials (including first-in-human), overseeing protocol development, medical monitoring, patient safety review, and day-to-day clinical execution.
Responsibilities:
- Support physician lead for medical monitoring: eligibility, protocol deviations, adverse events, concomitant meds, labs, ECGs; ensure participant safety and data integrity.
- Guide investigator enrollment decisions; contribute to protocol and SAP development, clinical study reports, investigator brochures; design PK sampling schedules.
- Author/review clinical IND/CTA sections, briefing books, meeting requests, marketing applications; participate in FDA/EMA interactions.
- Integrate nonclinical/translational/biomarker/clinical data to inform decisions.
- Oversee clinical pharmacology and dose selection/justification; provide input on DDI, food effect, hepatic/renal impairment, QT/QTc, special populations.
- Conduct/oversee NCA, population PK, exposure–response, PBPK, mechanistic PK/PD (hands-on or with scientists/vendors).
- Oversee PK strategy, bioanalytical assay development/validation, CRO/vendor deliverables and quality.
- Lead/maintain protocols and key clinical documents (protocols, amendments, IBs, informed consent forms, medical monitoring plans); partner with Pharmacovigilance on safety signals and safety committees.
- Collaborate cross-functionally (Clinical Ops, Biostatistics, Data Management, Regulatory, Translational, Program Mgmt) for start-up, execution, and closeout.
Required Education & Experience:
- PharmD or equivalent advanced degree in Clinical Pharmacology/Pharmacometrics/related field.
- 5+ years progressive clinical drug development experience.
- Experience supporting Phase 1–3 trials including medical monitoring; authoring clinical/regulatory documents.
Required Qualifications/Skills:
- Expertise in protocol design, medical monitoring, safety review, and Phase 1–3 execution.
- Ability to interpret clinical/lab/PK/PD/safety data.
- Strong scientific writing; collaborate effectively; excellent communication/presentation; manage multiple programs.
Preferred:
- Active pharmacist/medical licensure.
- Modeling software (NONMEM, Phoenix WinNonlin, Monolix, R/Simcyp/GastroPlus/Python, PBPK platforms).
- Prior clinical-stage biotech experience.
Compensation/benefits (stated):
- Salary expected ~$230,000–$250,000 depending on experience; remote work; paid time off and health/401(k) benefits (as listed).