Clinical Program Director
13 hours ago
This is a unique opportunity to be a major contributor to the success of a well-positioned and well-financed cutting-edge Biotech company.
About the JobWe are seeking an experienced Clinical Program Director to lead our international clinical development programs. The successful candidate will have a strong background in clinical operations and experience in managing cross-functional teams.
The Clinical Program Director will be responsible for developing, implementing and leading clinical development programs in line with business strategy. They will also lead a cross-functional team responsible for timely, high-quality execution of trials.
Responsibilities- Develop, implement and lead clinical development programs in line with business strategy.
- Lead a cross-functional team responsible for timely, high-quality execution of trials.
- Contribute to program strategy as part of a cross-functional team and translate scientific imperative to drive effective operational strategy for delivery.
- Be accountable for effective management of clinical deliverables, including study protocols and other study documents, contracts, timelines, outsourcing and risk management plans, and for communicating progress internally/externally.
- Oversee and contribute to the development of IND/Clinical Trial Authorisation (CTA) packages and documentation, in alignment with program-related objectives and regulatory requirements.
- Support engagement and discussions with regulatory authorities to advance Mestag's novel immunotherapies.
- Be accountable for outcomes from outsourcing partnerships and the delivery of trial metrics, including ensuring enrolment targets are met and data are collected as planned, and for problem-solving issues that may arise.
- Build confidence with study data monitoring committees, trial steering committees, and other study governance groups on study design, progress, metrics, and safety.
- Build and maintain relationships with external stakeholders, including key clinical opinion leaders and investigators/staff to develop collaborations in support of business aims.
- Plan and manage clinical budgets in line with the business needs.
- Ensure full compliance with ICH GCP and other relevant regulatory requirements and that trials are conducted to the highest standard.
We offer a highly competitive total rewards package including a salary range of £80,000 - £120,000 per annum, pension contributions, private medical insurance, income protection and more.
We have access to state-of-the-art instruments at our laboratory and office facilities at Chesterford Research Park near Cambridge, UK. Our founding investigators comprise global experts in inflammatory disease, cancer, computational biology and fibroblast biology from the University of Oxford, Brigham & Women's Hospital, Harvard Medical School and Cold Spring Harbor Laboratory.
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