The biggest bottleneck in bringing new treatments to patients is clinical development. Getting a drug through the development process often takes a decade & may cost over a billion dollars. And the problem is only getting worse.
TrialSpark is a technology company that brings new medical treatments to patients faster. Were reimagining the clinical trial by using technology to streamline every aspect of the trial. On top of that, to fulfill our mission, were acquiring our own drug assets & acting as a full stack drug development company to truly transform end-to-end clinical development.
About the position
As the VP of Clinical Operations at TrialSpark, youll be responsible for leading & managing three key groups within TrialSpark: Clinical Project Management, Clinical Trial Management (Monitoring/Study Regulatory), & Data Management. You will work cross-functionally to build clinical operational strategies for the TrialSpark study portfolio, as well as promote innovation & process excellence within & across all ongoing & future studies.
Your day-to-day activities will include the implementation & execution of the overall clinical studies strategy, ensuring consistency, quality & compliance with global clinical standards & regulations. In addition to running the day-to-day, you will be charged with driving efficiency & speed in the clinical trial process.
TrialSpark is looking for a First Principles thinker who can develop & execute on an innovative clinical operations strategy. We are only looking for candidates who can help us create a world where clinical trials are run differently; in line with our mission to bring new treatments to patients faster by reimagining the clinical trials process.
Key Responsibilities will include:
- Provide strategic direction & leadership for collaboration of key TrialSpark teams, including Clinical Project Management, Clinical Trial Management, & Data Management to ensure cross-functional efficiency to support all TrialSpark clients.
- Provide oversight over key GxP vendors throughout study execution
- Partner with BD & commercial teams upstream to ensure trial designs for upcoming studies are sound & are a good fit for TrialSparks operating model.
- Collaborate with Medical, Technology, & Data to develop & execute on strategies for running clinical operations, creating efficiencies & delivering high quality clinical trials.
- Assess & implement innovative clinical trial & data management approaches, focusing on quality & efficiency.
- Represent, advocate, & promote TrialSparks approach externally to Sponsors, Partners, & Regulatory Authorities.
- Provide direction & mentorship to staff including setting goals that are aligned with both corporate & project goals.
Clinical Trial Oversight:
- Oversee technical expertise for the development of clinical trial documentation & trial conduct, including oversight of Key Performance Indicators, Key Risk Indicators & budgetary indicators both within & across programs.
- Oversee end-to-end tracking of clinical trial delivery & collaboration with other functions to identify & mitigate issues as they arise to ensure timely & on-budget trial execution.
- Lead executive steering committee meetings with our Sponsors
- Partner with QA to maintain inspection readiness across all programs.
- Support development of clinical operational standards, such as SOPs, forms, templates & tools as necessary to ensure timely, efficient & high quality clinical trial deliverables.
- Represent TrialSparks clinical operations team in sponsor-facing Bid Defense meetings.
- Ensure the clinical operations resources assigned to a trial are the most appropriate for the sponsors requirements.
- Find & offer solutions which employ TrialSparks unique strengths/competitive advantages.
- A demonstrated ability to plan & lead teams in executing complex global clinical programs & trials.
- Deep experience with all aspects of trial management, including feasibility, study planning & budgeting, study resourcing, vendor management, risk management, stakeholder management, & more.
- Thorough knowledge & understanding of drug development & clinical research concepts, practices, & regulations.
- Critical thinker with the ability to step back & rethink legacy assumptions in the clinical research space; should be able to point to whats wrong, & how you would do it differently if starting from scratch.
- Embraces open conversations & challenges to status quo thinking.
- Excellent cross-functional partnership skills; you know how to work across an organization to achieve objectives & meet timelines.
- Solid written & oral communication skills; can synthesize complex concepts & deliver messages clearly.
- Competency with data analysis & fluency with managing to metrics & key performance indicators.
Skills & Competency
- Expertise in drug development, operations & strategic planning, as well as clinical operations & clinical project management.
- Experienced in running clinical development projects under the Code of Federal Regulations (CFR), International Council for Harmonization Good Clinical Practices (ICH-GCP).
- Ability to work on & solve complex problems.
- Proven ability to build & develop high-powered teams while fostering productivity, cohesiveness & collaboration.
- Excellent communication skills & experience in a dynamic & growing organization.
- BS or BA required, preferably in life sciences or a related field; advanced degree preferred.
- Minimum of 15 years experience in clinical development in the pharmaceutical and/or biotechnology industry, clinical research organizations, academic research organizations, or clinical research institutions.
- Minimum of 10 years of clinical operations experience.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.