Novocure is currently seeking to fill the position of an Director of Clinical Operations. The incumbent will assume oversight responsibilities of all clinical trial operations and will be required to implement and oversee all areas of early and late phase clinical study management in North America and other regions as needed. This full-time, exempt position will be located at our US Operations Center.
He/she will be responsible for the operational execution of all Novocure sponsored clinical trials within the assigned regions in line with the company's global policies and procedures and applicable standards of Good Clinical Practice. He/she will be leading and manage the clinical study team located in North America, as well as working with CRO's and Vendors to ensure that the studies are completed on time, within budget, and in compliance with SOPs and all applicable regulations. The new incumbent will also be responsible for sites and vendors selection, in accordance with the top management's final adjudication.
The Director of Clinical Operations will interface with other functional departments in particular quality, technical and supply chain teams to facilitate timely execution of all clinical related activities.
The Director of Clinical Operations will report directly to the Global Director of Clinical Operations and will directly manage the team located in North America. The Director of Clinical Operations is also expected to further grow and develop the clinical operations staff as needed and approved.
Essential Duties and Responsibilities:
- Ensure highest quality standards of conduct across all clinical trials adhering to pre-determined timelines and budget. Secure reliable execution and delivery (quality, cost and time) of clinical studies to support global program requirements:
- Oversight of study operational strategies and plans
- Oversight of study budget planning and management.
- Ongoing monitoring of issues/risks and remediation measures.
- Serve as a mentor for team members, providing guidance and directions on day-to-day clinical operations as needed, and ensuring appropriate training for the team.
- Serve as a representative of the clinical operations team facing trial investigators across all studies in conferences, investigator meetings and other relevant forums.
- Provide direction to partnership/s with external vendors, including functional and regional representation in partnership governance bodies and sponsor oversight for operational strategy, performance and quality.
- Achieve project and corporate objectives through the clinical operations teams in North America.
- Coordinate with other corporate teams, clinical research organizations and consultants as needed.
- Ensure compliance with all applicable internal policies and procedures, GCPs, and all applicable regulations; ensure inspection readiness of all regulated activities.
- Ensure activities comply with the applicable Novocure Quality System requirements.
- Grow and develop the Clinical Operations team to enable efficient and high quality execution of global clinical studies.
- Maintain a result-focused organization driving fast patient recruitment for a number of clinical trials.
- At least 10 year-experience in managing clinical trials, preferred from CRA level up to global clinical operations.
- Experience working hands-on on phase I/II and phase III studies.
- Global experience in North America and EU is a prerequisite and additionally experience in Asia-Pacific would be welcome.
- At least 3 years of oncology experience. Medical Device experience would be a plus.
- Past sponsor experience is a prerequisite and preferably CRO experience.
- Experience in regulatory aspects of trials (EC/IRB & competent authority interactions, submission preparation, not necessarily as primary RA expert).
- Strong Self-Starter and hardworking individual who is used to work quite independently.
- Excellent English and additional languages preferred.
- Bachelor's Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable.
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