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Vice President of Clinical Research

External
knownwell logoKnownwell ยท Boston, MA
$205Kโ€“$260K/yrFull-timeRemote2d ago
Clinical TrialsComplianceDocumentationForecasting
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Responsibilities

  • 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; the VP sets standards and removes barriers, not day-to-day task management.
  • 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
  • Build and manage 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
  • Develop revenue forecasting by study and by sponsor, incorporating enrollment projections, milestone schedules, and contract terms; maintain a rolling 12-month revenue outlook
  • Establish service line KPIs, site performance metrics, and sponsor satisfaction benchmarks
  • Proactively identify risks - enrollment gaps, protocol deviations, sponsor issues - and resolve before they escalate

Requirements

  • Required
  • 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 mu

Benefits

Health insurance

Additional Information

๐Ÿ‘‹ Meet knownwell , weight-inclusive healthcare for all . Join a dynamic company that is changing the way obesity care is delivered. We offer weight management, primary care, nutrition counseling, and health coaching. Our care model combines in-clinic and virtual care to bring support to patients where and when they need it. Backed by $50M in funding-including a $25M round led by CVS Health Ventures with support from a16z Bio + Health, Flare Capital, MassMutual, and Intermountain Ventures-we're scaling fast and expanding access to evidence-based obesity care nationwide. The Vice President of Clinical Research is an operational executive and the senior-most leader of knownwell's research service line. This is an assess-modernize-and-scale role: you will inherit a running but under structured trials program and build the infrastructure, systems, and talent needed to take it to the next level You will report to the CEO and work closely with the Chief Medical Officer, President, Director of Research and our pharmaceutical partners. You will be accountable for the full lifecycle of every trial knownwell hosts - from sponsor relationships and site activation through enrollment, data integrity, regulatory compliance, and closeout. Along with our CMO, you will also serve as the commercial face of our trials program, developing new sponsor relationships and positioning knownwell as a preferred site for trials in metabolic health and related disease areas. This role is right for someone who thinks in systems, runs tight operations, and has a proven record of delivering trials on time and on budget at the site level.


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