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
We are seeking an experienced Senior Clinical Trial Manager to lead our clinical trial programs in ophthalmology. This is a fully remote position, and the successful candidate can live in any of the continental US states.
Position Summary:
Reporting to the VP of Clinical Operations, the Senior Clinical Trial Manager provides senior-level leadership for the 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.
Job Duties:
- Independently leads and manages Phase I/Ib/II/III clinical studies of moderate to high complexity, including large regional and/or global trials.
- Provides senior clinical operations leadership across the study lifecycle, including study start-up, enrollment, maintenance, closeout, and inspection readiness activities.
- Drives execution of study operational plans, timelines, budgets, risk mitigation strategies, communication plans, monitoring plans, and vendor oversight plans to ensure timelines are met.
- Serves as the primary operational lead for assigned studies and may lead clinical operations workstreams within larger development programs.
- Leads cross-functional study teams, facilitates effective decision-making, and ensures alignment across internal stakeholders, CROs, contractors, vendors, and clinical research sites.
- Provides primary CRO and vendor oversight, including performance management, issue escalation, deliverable review, and accountability for quality, budget, and timelines.
- Contributes to the development, review, and implementation of clinical plans, study budgets, study timelines, and operational feasibility assessments.
- Identifies, assesses, and escalates study risks and implements proactive contingency and mitigation strategies to support successful trial delivery.
- Oversees clinical systems, including EDC, CTMS, eTMF, IWRS, and lab portals, ensuring data integrity, quality control, timely updates, and accurate study status reporting.
- Maintains TMF quality, completeness, and inspection readiness in partnership with internal teams, CROs, and vendors.
- Prepares and communicates regular study updates, milestone reports, dashboards, and performance metrics to internal and external stakeholders.
- Supports and oversees study data review, data cleaning, query resolution, and database lock activities by clearly communicating expectations and timelines.
- Maintains proactive interaction with clinical research sites and provides field-based monitoring or site management support as required.
- Manages study correspondence, documentation, and files to support high-quality study execution and audit readiness.
- May mentor or provide guidance to junior clinical operations staff, contractors, or study team members.
- Able and willing to Travel to study sites to build site relationships and knowledgeable in the operational conduct and oversight of ophthalmic studies
Required Education & Experience
- 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.
Required Qualifications
- Exceptional communication, interpersonal, leadership, and influencing skills with the ability to lead cross-functional teams and external partners.
- Strong written and verbal communication skills, including the ability to prepare concise study updates, escalation summaries, and operational reports.
- Highly reliable, self-motivated, solutions-oriented team player with sound judgment and accountability for study outcomes.
- Detail-oriented with advanced organizational, prioritization, and project management skills.
- Advanced proficiency in Microsoft Office,Smartsheets, Microsoft Excel, and clinical trial tracking and reporting tools.
- In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, clinical trial regulations, and inspection readiness expectations.
- Demonstrated ability to manage multiple complex studies, tasks, vendors, and competing priorities in a fast-paced, collaborative environment.
- Deep understanding of clinical systems used in studies, including EDC, eTMF, IWRS, lab portal systems, and related data flow processes.
- Advanced proficiency in Trial Master File (TMF) management, quality control, completeness, and inspection readiness.
- Hands-on experience overseeing clinical systems and clinical operations documentation, including eTMF, CTMS, EDC, study plans, trackers, and reports.
- Experience maintaining audit and regulatory inspection readiness across studies and vendors.
- Experience working in a small or early-stage biotech company, with flexibility to operate in a hands-on, resource-conscious environment.
- Experience working with global, regional, and/or multi-site clinical trials.
- Demonstrated CRO and vendor oversight experience, including performance management, anticipating and mitigating issues, and deliverable accountability.
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.
Our workplace
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. Many positions (including this one) are remote, allowing our team members to work from anywhere. The salary for this role is expected to be approximately $165,000 - $185,000, depending on experience. We are open to the concept that different experience levels add value to the team in different ways, and therefore will consider a variety of experience and offer commensurate pay.
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.