Vice President, Clinical Operations
BIOAGE LABS
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 a highly experienced and motivated leader to join our team as VP-Clinical Operations to bring our portfolio of drugs through clinical trial execution and approval.
The job: Provide leadership, management, and oversight of clinical operations and data management to ensure the effective and efficient conduct of clinical trials according to industry standards and regulatory requirements. Develop and implement processes to manage programs through external resources. Ensure operational excellence, regulatory compliance, and adherence to budgets and timelines. Serve as the strategic voice of Clinical Operations to executive leadership and external stakeholders.
You: A highly experienced clinical leader who has successfully managed clinical studies with external resources and has a passion for translational medicine. Deeply knowledgeable about clinical study design and operations, data management and analysis, regulatory affairs, and project management, you thrive on navigating complex programs successfully to deliver impact.
Us: A well-funded company with an important mission; competitive compensation and generous benefits; and a flexible, work-from-anywhere culture that emphasizes creativity, autonomy, and growth potential for all team members.
Responsibilities
- Lead Clinical Operations and Data Management, including direct oversight and management of external staff and external resources (CROs, vendors, consultants).
- Effectively plan, execute and deliver clinical study results and be accountable for tracking and delivering in accordance with corporate timelines.
- Develop, manage and communicate effectively the clinical timelines and budgets, key performance indicators (KPIs) and status toward corporate goals in support of corporate objectives.
- Identify and directly manage CROs and vendors to meet high-performance standards, including site identification and selection, data management and analysis, bioanalytical, budgeting, timelines, with oversight of clinical and operational plans.
- Ensure adherence to GCP, regulatory, quality requirements across all clinical trials.
- Partner with Clinical Science in the development and planning of clinical trials with operational responsibility for authoring the protocol, understanding the objectives and evaluating study design, feasibility and regulatory requirements
- Authoring and/or review of clinical manuals and documents supporting the execution of clinical trial protocols and regulatory submissions.
- Represent Clinical Operations to executive management; accountable for clinical SOPs and departmental documents (protocols, manuals).
- Oversee clinical statement of work orders for adherence to scope of work and contractual obligations.
- Continuously drive operational excellence and process optimization.
- 20% or more travel may be required – domestic and international
Qualifications
- Advanced degree, or BS degree in science, nursing, health or related field
- 15+ years of experience in clinical operations in a pharmaceutical or biotech environment,
- 7+ years of experience independently leading and managing a clinical operations team, including end to end management and oversight of Phase I-III trials across multiple programs
- Critical traits for success include: strategic and proactive thinking, strong scientific and analytical skills, decisiveness and ability to perform as a respected team member and leader.
- Skill and prior experience at building the necessary infrastructure and processes to support clinical operations.
- Deep knowledge of the drug development process, GCP, and global regulatory requirements (US, EU).
- Strong budgeting and financial skills with a proven track record of operational efficiency and cost control
- Demonstrated ability to liaise with other functions (regulatory, quality, finance, etc.) and key partners
- Strong leadership, communication, and delegation skills to drive key initiatives and objectives.
- Flexibility and organizational ability to manage projects and teams efficiently.
- Advanced knowledge of clinical research, trial management, and data.
- Expertise with operational metrics, quality standards, and compliance requirements
- Proficiency with documentation, reporting, and presentations to key stakeholders.
- Strong organizational, time-management, and project management abilities
- Excellent written and verbal communication skills.
Compensation
In addition to a competitive salary, BioAge offers 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), a 401(k) retirement savings plan with matching employer contributions, and support for families through childcare and fertility benefits. We also pride ourselves on giving employees a wide range of opportunities for career development, including a generous annual budget for continued learning, conference participation, and training and skill development. Many positions (including this one) are remote, allowing our team members to work from anywhere. The starting salary for this role is expected to range between $300,000 to $325,000 per year for an applicant meeting the minimum qualifications, and may be adjusted higher or lower based on experience.
Our company
BioAge is a platform-driven, clinical-stage biotechnology company that is mapping human longevity to change the nature of aging and extend healthy lifespan. Our growing portfolio of therapeutics for immune, muscle, and brain aging includes four drug programs, two first-in-class and two first-in-indication. Our vision is “growing older without aging” - a future in which aging allows us to pursue our goals, accumulate new experiences and accomplishments, and actively contribute to society without disease, physical disability, or loss of independence and connection. A leading company in the emerging longevity biotech sector, BioAge has raised more than $300 million from a top-tier syndicate of investors and pharma companies. For additional information about BioAge, visit the company’s website at https://bioagelabs.com.
Our workplace
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.