Phone: (267) 387-0090
Position Overview
We seek a clinical operations leader who will provide strategic and operational leadership of multiple global clinical studies to meet aggressive timelines, on budget, ensuring compliance with all relevant regulatory guidelines.
The successful candidate will lead a team of internal and external clinical operations professionals and will immediately assume leadership for execution of three simultaneous global phase 2 clinical trials studying a potentially breakthrough new therapeutic for high unmet medical need indications. This leader of Clinical Operations will directly manage program level responsibilities, including budget, timeline, and drug supply management and forecasting, and will support efforts in the planning, execution, oversight, and reporting of all phases of clinical trials.
Job Responsibilities
- Lead all operational aspects of cross functional clinical programs, including strategic planning, communication, coordination, delegation, and stepping into direct action as necessary to make sure goals are achieved on time and on budget.
- Vendor Management: Primary lead managing the Contract Research Organizations (CROs), vendors, and other third parties. Oversight of all clinical trial-related partners and vendors. Drive vendors to meet aggressive timelines, on budget, and hold them to account if they fall behind.
- Patient Recruitment: Lead the operational strategy and execution for identifying, recruiting, and retaining trial subjects.
- Quality: In partnership with the VP Regulatory and QA, develop and continuously improve clinical SOPs and GCPs and provide oversight of clinical monitoring quality & adherence to established processes and plans in compliance with GCP.
- Risk Management: Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks and make appropriate trade-offs of balancing risks with study deliverables and costs.
- Supply Management: Oversee and work collaboratively with vendor on clinical supply forecast and re-supply.
- Ability to build strong, collaborative, and dynamic relationships with co-workers of diverse backgrounds and expertise.
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
- Willingness to travel for internal corporate and external investigator and scientific meetings, both nationally and internationally. Travel estimated at 20%.
- Comfortable working in a virtual team with schedule flexibility to build and maintain relationships across time zones from eastern Europe to Australia.
- Values-based leadership consistent with company’s core values.
Job Requirements
- Bachelor’s degree or higher in Life Sciences, or Project Management.
- Minimum 10 to 12 years of clinical operations management experience required.
- Phase 2 and 3 global clinical trial management. Experience with trials for rare and common disease preferred.
- Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices (GCP), ICH and applicable Standard Operating Procedures.
- Demonstrated ability and track record to recruit, manage, mentor, & train other operations team members in a positive and effective manner.
- Demonstrated ability to manage CROs (and other vendors) to meet or exceed KPIs tied to corporate goals and hold them to account if they fall behind.
- Ability to lead the clinical operations team, and collaborate with other internal colleagues, to achieve all elements of complex programs on timelines to meet or exceed corporate goals.
- Ability to effectively communicate with and influence senior level stakeholders to gain buy-in on clinical strategy.
Location(s)
If interested, please send a MS Word version of your resume to [email protected]
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