Summary: 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 within a small, collaborative team, 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.
You: You prefer working in small, fast paced biotech environments where you're interacting at all levels of the organization. You have experience providing clear direction and oversight on all trial related activities from study start up through close out on multiple trials using multiple vendors/CRO's. You like working with data and metrics, anticipating and then mitigating risks, and managing study timeline deliverables and budgets. You are productive and motivated while working remotely, and have the flexibility to travel up to 35% when needed.
Essential Job Duties:- Responsible for the execution of clinical programs and trials by creating and managing the timeline, budget, and resources of clinical activities. This includes close supervision of CROs and vendors for clinical trial management, data management, study drug management/supply, biostatistics, pharmacovigilance, as well as central, bioanalytical and CORE laboratories.
- Leads the clinical trial execution team by maintaining effective relationships through open communication, partnership, and collaboration with internal stakeholders and external collaborators to meet trial and corporate goals
- Knowledge and understanding and management of external data management and clinical systems vendors, including being an effective end-user of Clinical Systems (e.g. EDC, IRT, eTMF, etc.)
- Directs exploratory feasibility exercises and oversees identification of study sites at program or indication level
- Facilitates productive communications with clinical sites to achieve the biggest impact on subject enrollment and protocol compliance.
- Ensures quality data through the drafting and review of protocols, informed consents, clinical study reports, and other study documentation as well as oversight of ongoing data reviews and clinical site monitoring throughout the study.
- Assures GCP compliance through the drafting and review of standard operating procedures as well as the facilitation of audits with Quality.
- Develops key performance indicators (KPI)'s and ensure risk mitigation plans are in place for each trial.
- Provide BioAge teams (e.g. Core team and Clinical Science) with strategic operational input, including cost, feasibility of study design, timelines, logistics and allocation
- Participates in the preparation and review of regulatory filings as needed.
- Mentors other clinical operations study team members.
- Implements Risk-Based Quality Management (RBQM) strategies for ongoing data reviews and monitoring oversight in alignment with ICH GCP guidelines.
- Drives diversity and inclusion strategies in patient recruitment and retention across clinical sites.
- Maintains continuous inspection readiness for clinical trial sites and the electronic Trial Master File (eTMF).
- Conducts regular vendor governance meetings and formal scorecard/KPI reviews to ensure operational accountability.
- Knowledge of therapeutic areas (e.g. metabolic, ophthalmology, cardiovascular, Obesity) a
- Willing and able to travel to attend conferences to meet with and build relationships with KOL's and and clinical sites
Required Skills and Abilities:- 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, key performance indicators, project and risk management plans and budgets
- Ability to work in an adaptive environment by remaining flexible, proactive, and efficient
- Strong verbal and written communication skills
- A highly collaborative person who can respond to constantly changing circumstances and needs
- Strong leadership skills, with demonstrated project or program management and critical thinking skills
- Strong site management and Key Opinion Leader interaction skills
- Ability to mentor others
- Advanced proficiency in Microsoft Office, Adobe PDF, MS Excel, smartsheets, Excel, Gmail, Zoom/MS Teams, Google Meet, Sharepoint, Docusign, electronic data capture, interactive response technology, electronic trial master files and investigator site files
Education and Qualifications:- BA/BS degree minimum preferably in a life science related field or equivalent
- 15 years experience in clinical trial research minimum.
- Demonstrated knowledge of all phases of the drug development process at a Biotechnology or pharmaceutical company
- Experience managing Clinical Research Organizations (CROs), central laboratories, IXRS, EDC and other vendors
- Expert knowledge of ICH/GCP guidelines, regulatory requirements, and clinical trial operations
