The biggest bottleneck in bringing new treatments to patients is clinical development. Getting a drug through the development process often takes a decade and 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. We’re reimagining the clinical trial by using technology to streamline every aspect of the trial. On top of that, to fulfill our mission, we’re acquiring our own drug assets and 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, you’ll be responsible for leading and managing three key groups within TrialSpark: Clinical Project Management, Clinical Trial Management (Monitoring/Study Regulatory), and Data Management. You will work cross-functionally to build clinical operational strategies for the TrialSpark study portfolio, as well as promote innovation and process excellence within and across all ongoing and future studies.
Your day-to-day activities will include the implementation and execution of the overall clinical studies strategy, ensuring consistency, quality and compliance with global clinical standards and regulations. In addition to running the day-to-day, you will be charged with driving efficiency and speed in the clinical trial process.
TrialSpark is looking for a First Principles thinker who can develop and 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 and leadership for collaboration of key TrialSpark teams, including Clinical Project Management, Clinical Trial Management, and Data Management to ensure cross-functional efficiency to support all TrialSpark clients.
- Provide oversight over key GxP vendors throughout study execution
- Partner with BD and commercial teams upstream to ensure trial designs for upcoming studies are sound and are a good fit for TrialSpark’s operating model.
- Collaborate with Medical, Technology, and Data to develop and execute on strategies for running clinical operations, creating efficiencies and delivering high quality clinical trials.
- Assess and implement innovative clinical trial and data management approaches, focusing on quality and efficiency.
- Represent, advocate, and promote TrialSpark’s approach externally to Sponsors, Partners, and Regulatory Authorities.
- Provide direction and mentorship to staff including setting goals that are aligned with both corporate and project goals.
Clinical Trial Oversight:
- Oversee technical expertise for the development of clinical trial documentation and trial conduct, including oversight of Key Performance Indicators, Key Risk Indicators and budgetary indicators both within and across programs.
- Oversee end-to-end tracking of clinical trial delivery and collaboration with other functions to identify and mitigate issues as they arise to ensure timely and 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 and tools as necessary to ensure timely, efficient and high quality clinical trial deliverables.
- Represent TrialSpark’s clinical operations team in sponsor-facing Bid Defense meetings.
- Ensure the clinical operations resources assigned to a trial are the most appropriate for the sponsor’s requirements.
- Find and offer solutions which employ TrialSpark’s unique strengths/competitive advantages.
- A demonstrated ability to plan and lead teams in executing complex global clinical programs and trials.
- Deep experience with all aspects of trial management, including feasibility, study planning and budgeting, study resourcing, vendor management, risk management, stakeholder management, and more.
- Thorough knowledge and understanding of drug development and clinical research concepts, practices, and regulations.
- Critical thinker with the ability to step back and rethink legacy assumptions in the clinical research space; should be able to point to what’s wrong, and how you would do it differently if starting from scratch.
- Embraces open conversations and challenges to status quo thinking.
- Excellent cross-functional partnership skills; you know how to work across an organization to achieve objectives and meet timelines.
- Solid written and oral communication skills; can synthesize complex concepts and deliver messages clearly.
- Competency with data analysis and fluency with managing to metrics and key performance indicators.
Skills & Competency
- Expertise in drug development, operations and strategic planning, as well as clinical operations and 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 and solve complex problems.
- Proven ability to build and develop high-powered teams while fostering productivity, cohesiveness and collaboration.
- Excellent communication skills and experience in a dynamic and 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.