Senior Director, Clinical Operations

BioAge Labs, Inc.; Emeryville, Northern (CA, KY); Hybrid; USD 270,000 - 280,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Job summary

BioAge Labs, Inc. seeks a Senior Director of Clinical Operations to lead execution of clinical programs and trials. You will manage timelines, budgets, and CRO/vendor relationships to ensure quality, GCP compliance, and on-time delivery.

You will guide cross-functional teams, drive RBQM and KPI governance, and mentor staff while supporting regulatory filings and risk management. Remote work with travel up to 35% is required.

Qualifications

• Clinical research experience including onsite monitoring.
• Demonstrated knowledge of all phases of drug development at biotech/pharma.
• Experience managing CROs and vendors (EDC/IXRS/central labs).

Responsibilities

• Lead execution of clinical programs and trials with timelines, budgets, and resources.
• Oversee CROs, data management, bioanalytical labs, and trial vendors.
• Ensure QMS, RBQM, and ICH GCP compliance across trials.
• Mentor clinical operations team members and drive KPI tracking.

Skills

Clinical trial management

Vendor management

Budgeting & timelines

GCP/ICH knowledge

Cross-functional leadership

Data-driven decision making

Communication

Team mentoring

Site management

Leadership

Education

BA/BS in life sciences

15+ years clinical trial experience

Experience with CROs/EDC/RTMS

Tools

EDC

eTMF

IRT

MS Office

Smartsheets

SharePoint

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

BioAge Labs is a clinical-stage biotechnology company that is harnessing the biology of human aging to develop novel targets and therapies for metabolic diseases.

We are seeking an experienced Senior Director of Clinical Operations preferably with experience leading trials in cardiovascular, metabolic disease or ophthalmology.

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.

• 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

Our company

BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The Company's lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for cardiovascular risk and retinal diseases including diabetic macular edema. BGE-102 has completed a Phase 1 SAD/MAD trial demonstrating a well-tolerated profile and potential best-in-class reductions in hsCRP and other inflammatory biomarkers in participants with obesity and elevated inflammation. Phase 2 cardiovascular risk proof-of-concept data are anticipated in H2 2026, and Phase 1b/2a diabetic macular edema proof-of-concept data are anticipated in mid 2027. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging. BioAge has been listed on Nasdaq (BIOA) since 2024. For additional information about BioAge, visit the company’s website at https://bioagelabs.com.

The salary for this role is expected to be approximately $270,000 - $280,000, depending on experience.

• 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.

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 .