Clinical Operations Director

1 day ago

Saffron Walden, Essex, United Kingdom Lifelancer Full time

About the Role

We are seeking a highly skilled and experienced Clinical Operations Director to join our team at Mestag Therapeutics. As a key member of our leadership team, you will be responsible for providing cross-functional leadership and clinical operations oversight for our international clinical development program.

About Us

Mestag harnesses new insights into fibroblast-immune interactions to develop impactful treatments for patients. We are progressing a pipeline of sophisticated first-in-class antibodies designed to improve the lives of patients with cancer and inflammatory disease. Our state-of-the-art facilities at Chesterford Research Park near Cambridge, UK, provide an ideal environment for our dedicated researchers to deliver incredible science.

Your Key Responsibilities

Develop, implement and lead clinical development programs in line with our business strategyPartner with Senior leadership to ensure alignment of strategy, objectives, and deliverables within each clinical programLead a cross-functional team responsible for timely, high quality execution of trialsContribute to program strategy as part of a cross-functional team and translate scientific imperative to drive effective operational strategy for deliveryBe 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/ externallyOversee and contribute to the development of IND/Clinical Trial Authorisation (CTA) packages and documentation, in alignment with program related objectives and regulatory requirementsSupport engagement and discussions with regulatory authorities to advance our novel immunotherapiesBe 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 ariseBuild confidence with study data monitoring committees, trial steering committees, and other study governance groups on study design, progress, metrics, and safetyBuild and maintain relationships with external stakeholders, including key clinical opinion leaders and investigators/ staff to develop collaborations in support of our business aimsEngage with advisory boards and other thought leaders to innovate and refine clinical development strategies and plansPlan and manage clinical budgets in line with our business needsEnsure full compliance with ICH GCP and other relevant regulatory requirements and that trials are conducted at the highest standardRecruitment, management and development of clinical operations staff as neededComplete all appropriate GXP/SOP training and adhere to all role specific SOP requirements

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