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Salary: USD 165,000 - 185,000 / annual
BioAge Labs is a clinical-stage biopharmaceutical company developing therapeutic candidates for metabolic diseases by targeting the biology of human aging. The company's lead product, BGE-102, is a brain-penetrant NLRP3 inhibitor being developed for cardiovascular risk and retinal diseases including diabetic macular edema. Phase 2 cardiovascular data are anticipated in H2 2026, and Phase 1b/2a diabetic macular edema data in mid 2027. BioAge is also developing long-acting injectable and oral APJ agonists for obesity, with additional preclinical programs addressing metabolic aging pathways. The company has been listed on Nasdaq (BIOA) since 2024.
Reporting to the VP of Clinical Operations, the Senior Clinical Trial Manager will provide senior-level leadership for planning, execution, oversight, and delivery of ophthalmology-related clinical studies across Phase I/Ib/II/III programs. This role independently leads complex regional and global clinical trials, drives operational strategy, manages study budgets and timelines, provides oversight of CROs and vendors, and ensures inspection readiness and compliance with GCP, ICH, protocol, and regulatory requirements.
Key responsibilities include: independently leading and managing Phase I/Ib/II/III clinical studies of moderate to high complexity, including large regional and/or global trials; providing senior clinical operations leadership across the study lifecycle (start-up, enrollment, maintenance, closeout, inspection readiness); driving execution of study operational plans, timelines, budgets, risk mitigation strategies, communication plans, monitoring plans, and vendor oversight; serving as primary operational lead for assigned studies and may lead clinical operations workstreams within larger development programs; leading cross-functional study teams and facilitating effective decision-making across internal stakeholders, CROs, contractors, vendors, and clinical research sites; providing primary CRO and vendor oversight including performance management, issue escalation, deliverable review, and accountability for quality, budget, and timelines; contributing to development, review, and implementation of clinical plans, study budgets, timelines, and operational feasibility assessments; identifying, assessing, and escalating study risks with proactive contingency and mitigation strategies; overseeing clinical systems (EDC, CTMS, eTMF, IWRS, lab portals) ensuring data integrity, quality control, timely updates, and accurate study status reporting; maintaining TMF quality, completeness, and inspection readiness; preparing and communicating regular study updates, milestone reports, dashboards, and performance metrics; supporting study data review, data cleaning, query resolution, and database lock activities; maintaining proactive interaction with clinical research sites and providing field-based monitoring or site management support; managing study correspondence, documentation, and files for audit readiness; mentoring or providing guidance to junior clinical operations staff; and traveling to study sites to build site relationships.
The position is fully remote; the successful candidate can live anywhere in the continental US.
REQUIREMENTS:
- BA/BS degree in Health, Life Sciences, or related field required; advanced degree preferred
- Experience overseeing clinical trials related to ophthalmic indications
- Minimum of 7 years of clinical operations or clinical trial management experience, or demonstration of equivalent capability
- At least 5 years of clinical research and development experience with a proven track record of independently managing clinical trials
- Prior experience leading or substantially overseeing Phase I/Ib/II/III clinical trials, including complex, global, regional, or multi-site studies
- Experience managing CROs, vendors, study budgets, timelines, and cross-functional study team deliverables required
- Exceptional communication, interpersonal, leadership, and influencing skills with the ability to lead cross-functional teams and external partners
- Ability and willingness to travel to study sites
- Knowledge of operational conduct and oversight of ophthalmic studies
