The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. 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 introducing a new model, using technology to streamline every aspect of the trial. To fulfill our mission, we partner with pharma, biotech, and digital health companies to run studies faster and more efficiently.
About the position
As the Head of Clinical Operations at TrialSpark, you’ll be responsible for leading and managing four key groups within TrialSpark: Clinical Project Management, Patient Operations, Vendor Management and Data Management. This role will be a primary stakeholder in roadmap development across all Clinical Operations functions. 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. You will work with team members to create the operational strategies for the TrialSpark studies portfolio, as well as promote innovation and process excellence within and across all TrialSpark functions. In addition to running the day-to-day, you will be charged with driving innovation and efficiency in the clinical trial process.
TrialSpark is looking for a First Principles thinker who can develop and execute on a solid clinical operations strategy. We are only looking for candidates who can help us create a world where clinical trials are thought of 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, Patient Operations, Data Management and the TrialSpark Study Operations teams to ensure cross-functional efficiency to support all TrialSpark clients.
- Develop and execute on strategies for scaling TrialSpark 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 TrialSpark externally to Sponsors, Partners and Regulatory Authorities.
- 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.
- Provide direction and mentorship to staff including setting goals that are aligned with both corporate and project goals.
- 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 the preparation and management of clinical trial budgets and timelines, as well as appropriate tracking mechanisms and tools.
- Develop clinical operational standards, such as SOPs, forms, templates and tools as necessary to ensure timely, efficient and high quality clinical trial deliverables.
- Establish and maintain inspection readiness across all programs.
- Determine clinical operations requirements for all sponsor (Pharma and Biotech) request for proposals, including labor, non-labor and third party costs.
- Represent TrialSpark’s clinical operations team in sponsor-facing Bid Defense meetings.
- Accountable for ensuring the clinical operations resources assigned to a trial are the most appropriate for the sponsor’s requirements.
- A demonstrated ability to plan and lead teams in executing complex global clinical trials.
- Deep experience with all aspects of study management, including feasibility, study planning and budgeting, study resourcing, vendor management, risk management, stakeholder management, and more.
- Thorough knowledge and understanding of clinical research concepts, practices, and regulations.
- Critical thinker with 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.
- 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: should have intermediate+ ability with Excel, 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.
- Very experienced and knowledgeable in the Code of Federal Regulations (CFR), International Council for Harmonization Good Clinical Practices (ICH-GCP).
- Knowledge of other GxP areas such as Good Manufacturing Practices (GMP) and Good Documentation Practices (GCP).
- Ability to work on and solve complex problems.
- Proven ability to foster team 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 the pharmaceutical and/or biotechnology industry.
- Minimum of 10 years of clinical operations experience, preferably including a strong background in clinical project management.
- Experience working with CROs (in a sponsor capacity) or at a CRO is required.
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.