Vice President of Clinical Research

Program Infrastructure and Strategy

Assess the current state of the trials program - people, processes, documentation, and technology - and build a prioritized plan to close gaps while keeping active trials on track.
Design and implement knownwell's end-to-end clinical trials operating model. Select, implement, and own the technology stack required to professionalize the program - including CTMS, eTMF, and the transition from paper source to electronic data capture - without disrupting active trials during migration.
Define the sponsor pipeline strategy — which therapeutic areas, which sponsors, which trial phases align with our patient population and care model.
Own the business case and budget for trials as a program, including revenue projections and resource requirements.

Sponsor Relationships and Business Development

Protect and deepen existing sponsor relationships, sponsor retention and repeat business are as important as new pipeline development at this stage of the program.
Identify, cultivate, and close relationships with pharmaceutical and biotech sponsors seeking multi-site primary care and metabolic health sites.
Negotiate site agreements, budgets, and payment milestones.
Represent knownwell at relevant industry forums and with potential sponsor partners alongside our CMO and CEO.

Site Operations and Execution

Hold accountability for the performance of all active trials across knownwell's clinic network — enrollment, data quality, monitoring readiness, and closeout — through the Director of Research and Clinical Trial Manager;
Coordinate across knownwell's clinical, growth, operations, and technology teams to embed trial workflows into existing clinical infrastructure without disrupting care delivery;
Manage relationships with CROs, IRBs, and regulatory bodies; own inspection readiness at all times;
Define the org structure, hiring plan, and growth trajectory for the trials team.

Performance and Reporting

Own a trials P&L and report progress, risks, and financial performance to the CEO and Board.
Establish full visibility into program costs, including staff time, clinical resource utilization, vendor spend, lab and imaging costs, and site-level overhead.
Own the budget for the trials program, including annual operating budget, per-study budget development, and ongoing variance tracking;
Translate budget decisions into financial projections the CEO and Board can act on.
Develop a milestone invoicing system that ensures knownwell invoices sponsors accurately and on time for every earned payment;
Identify and recover any milestones that have been missed or delayed under the current structure.
Build and manage a revenue forecasting system by study and by sponsor, incorporating enrollment projections, milestone schedules, and contract terms;
Maintain a rolling 12-month revenue outlook.
Proactively identify risks — enrollment gaps, protocol deviations, sponsor issues — and resolve before they escalate.

Qualifications

• 10+ years in clinical trials operations, with meaningful time at the site level or in a multi-site site management organization (SMO)
• Demonstrated track record of running concurrent trials across multiple sites — not just managing CROs or sponsors from afar
• Strong working knowledge of GCP, ICH guidelines, FDA regulations, and IRB processes
• Experience negotiating and managing sponsor and CRO relationships, including budgets and contracts
• Proven team builder; you've hired and developed trials staff in resource-constrained environments
• Financial fluency — you can build a budget, manage a P&L, and translate operational decisions into financial implications
• Comfortable operating in an early-stage, high-growth environment where the infrastructure you need doesn't exist yet

Paid Time Off

Up to 20 days of PTO per year + company holidays

Health Benefits

• Medical, dental, and vision insurance
• 401K retirement plan with company match

Family Support

• Up to 14 weeks of parental leave (12 for non-birthing parents)

Equal Employment Opportunity

knownwell, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.