We are seeking an experienced Head of Clinical Operations to join our client. As a science-based, privately-owned global pharmaceutical company, our client has a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide.
The main purpose of this role will be to provide oversight and operational strategy for Clinical Development Programmes while also providing leadership and strategic direction to the Development Operations team. The right candidate understands the needs and experiences of patients, and tailor’s solutions to achieve our client’s purpose. The Head of Clinical Operations is experienced to work in a highly matrixed and highly outsourced model, being able to manage vendors remotely.
This role will report into the Head of Development and will deputize the Medical Lead and team members as applicable.
- Provide strategic operational input into Clinical Development Plan (CDP) with respect to operational aspects and requirements (geographic reach, countries, feasibility, do-ability of proposed assessments, lead times, etc.) including definition of timelines/milestones and resource needs
- Leads the Development Operations team within the Clinical Development function and provides guidance, mentorship, and development
- Key member of development leadership team providing strategic input into the organization of the Clinical
- Development function: ability to deputize for the Head of Development
- Steer and oversee the planning, set-up, conduct and closure of the assigned projects and inherent clinical trial(s) including trial budgets, rolling forecasts and timelines/milestones
- Oversee adherence to Clinical Trial Protocol, applicable Functional Plan(s), applicable clients SOPs and any other applicable guidelines, laws and regulations as well as the contractual agreement(s) between our client and the assigned Vendor(s)
- Analyze and evaluate the impact of anticipated, new and updated project risks for the clinical trial(s) and continuously assess and action on ‘operational’ risks reported by Functional Experts and/or vendors on trial level
- Review and assess performance (quality, timelines, budget) of Vendor(s) and proactively initiate mitigations and improvements, follow up on progress to completion and ensure documented tracking thereof
- Support Global R&D Procurement in budget and contract negotiations with Vendors and scope revision and adjustment to obtain the most efficient way of executing the assigned trials/scope
- PhD in life or natural sciences; PMP certification is a plus
- Successful track record in related experience in a pharmaceutical company, biotech firm, or CRO, which should include strong operational and managerial experience in planning/start-up and execution of clinical trial
- International experience in Clinical Development and proven experience in developing effective relationship with Vendors (including budget negotiations and contracting) - Specific CRO experience is a plus
- Excellent leadership of multidisciplinary trial teams in a complex matrix environment, communication, and decision-making skills
- Thorough knowledge of GCP, project management (including the use of metrics and QTLs) and of Clinical Development from phase I to phase III
- Biometrics related to clinical trials conduct
- Demonstrated ability to build and develop high performing teams
- Fluency in English; additional European language is a plus