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Salary: USD 270,000 - 280,000 / annual
BioAge Labs is a clinical-stage biotechnology company developing novel therapies for metabolic diseases by targeting the mechanisms of aging. The company is Nasdaq-listed (BIOA) and has multiple clinical programs in progress, including Phase 2 cardiovascular risk trials and Phase 1b/2a diabetic macular edema studies.
The Senior Director of Clinical Operations will lead and oversee the execution of BioAge's clinical programs and ongoing trials, reporting to the VP of Clinical Operations. This role is responsible for driving clinical operational strategy, creating timelines, managing CROs and key trial vendors to ensure timelines are met with trial quality, GCP compliance, and within budget.
Key responsibilities include:
- Executing clinical programs and trials by creating and managing timelines, budgets, and resources of clinical activities
- Close supervision of CROs and vendors for clinical trial management, data management, study drug management/supply, biostatistics, pharmacovigilance, and laboratory services
- Leading the clinical trial execution team through effective relationships, open communication, partnership, and collaboration with internal stakeholders and external collaborators
- Managing external data management and clinical systems vendors (EDC, IRT, eTMF, etc.)
- Directing feasibility exercises and overseeing identification of study sites
- Facilitating communications with clinical sites to achieve enrollment and protocol compliance
- Ensuring quality data through drafting and review of protocols, informed consents, clinical study reports, and study documentation
- Assuring GCP compliance through SOPs and audit facilitation
- Developing KPIs and risk mitigation plans for each trial
- Providing strategic operational input to core teams on cost, feasibility, timelines, and logistics
- Participating in regulatory filing preparation and review
- Mentoring clinical operations team members
- Implementing Risk-Based Quality Management (RBQM) strategies
- Driving diversity and inclusion in patient recruitment and retention
- Maintaining inspection readiness for clinical trial sites and eTMF
- Conducting vendor governance meetings and KPI reviews
- Willing to travel up to 35% when needed, including conferences to meet with KOLs and clinical sites
The ideal candidate prefers working in small, fast-paced biotech environments and has experience providing clear direction and oversight on multiple trials using multiple vendors/CROs. Experience with cardiovascular, metabolic disease, or ophthalmology trials is preferred.
REQUIREMENTS:
- Clinical research experience, including onsite monitoring
- Creation, tracking, and closeout of budgets and timelines
- Ability to develop operational strategy for clinical programs, including development of timelines, enrollment projections, KPIs, project and risk management plans, and budgets
- Ability to work in an adaptive environment by remaining flexible, proactive, and efficient
- Strong communication and interpersonal skills
- Experience with clinical systems and data management platforms
- Knowledge of therapeutic areas (metabolic, ophthalmology, cardiovascular, obesity) preferred
- Ability to work productively and motivated while working remotely
- Flexibility to travel up to 35% when needed
