Head of Clinical Operations

Job title:

Head of Clinical Operations

Company

Mestag Therapeutics

Job description

Head of Clinical OperationsChesterford Research Park – CambridgeNever losing sight of our purposeAt Mestag we truly believe in our values and live by them every day. We’re ambitious about our science and its potential to deliver meaningful therapeutics to the patients that need them most. We believe in a culture of diversity, equality and investing in people to ensure our talented and passionate team members can fulfil their full potential.We are now transitioning our lead programme into clinic – There has never been a better time to join #TeamMestagScope of roleThe Head of Clinical Operations will provide cross functional leadership and clinical operations oversight for the timely, quality planning and execution of the international clinical development program. This is a unique opportunity to be a major contributor to the success of a well-positioned and well-financed cutting-edge Biotech company.Key Responsibilities

• Develop, implement and lead clinical development programs in line with business strategy
• Partner with Senior leadership to ensure alignment of strategy, objectives, and deliverables within each clinical program
• 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
• Engage with advisory boards and other thought leaders to innovate and refine clinical development strategies and plans

• 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 highest standard
• Recruitment, management and development of clinical operations staff as needed
• Complete all appropriate GXP/SOP training and adhere to all role specific SOP requirements

Experience

• BSc in a relevant discipline as a minimum; PhD with specialisation in immunology or cancer research-related field highly beneficial.
• Extensive experience preferably in industry (Pharma, biotech or CRO) in Phase 1-3 oncology/immunotherapy drug development.
• Strong preference for candidates with early stage clinical development experience
• Thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines, and an understanding of regulatory considerations for oncology therapies including CMC, Clinical and non-clinical activities.
• Proven track record in Phase 1-3 studies and trial designs as well as the successful submission of CTAs, INDs.
• Experience in establishing processes for optimising clinical trial delivery
• Excellent leadership, communication, interpersonal and presentation skills
• Science and data-driven with excellent analytical and problem-solving skills
• Experience in a fast-paced, entrepreneurial environment, with an ability to multi-task whilst maintaining attention to detail
• Flexibility and a willingness to do what needs to be done

In return we can offer youWe work flexibly with a strong team spirit and offer a highly competitive total rewards package including competitive salaries, pension contributions, private medical insurance, income protection and more.We have access to a range of onsite facilities including a gym, canteen, golf course and free onsite parking.As a team we achieve great things each day, and we take the time to celebrate successes, share and learn. We value the relationships of our close-knit team and strive to make meaningful connections in our community. We frequently hold Town Halls and team lunches, and have an active social committee, organizing regular events and ‘giving back’ activities supporting charities close to our hearts.Feel free to have an informal discussion with us for any questions you may have, we are happy to talk to you. Send your CV in the first instance.About Mestag TherapeuticsMestag 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. Together with our collaboration partner MSD, we are also identifying novel targets for future therapies.We are based in spacious and modern laboratory and office facilities at Chesterford Research Park near Cambridge, UK – right in the very heart of the UK life science sector. Our facilities are kitted out with state-of-the-art instruments to enable our dedicated researchers to deliver incredible science.Mestag is backed by committed leading global investors, has world-class founders and a highly experienced leadership team.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. We are supported by leading life science investors SV Health Investors, Johnson & Johnson Innovation – JJDC, Inc., Forbion, GV (formerly Google Ventures) and Northpond Ventures.Mestag is headquartered in Cambridge, UK, and in 2021 was recognized on the Fierce 15 list of innovative biotechnology companies.For further information please visit our website www.mestagtherapeutics.com

Expected salary

Location

Cambridgeshire

Job date

Sun, 15 Dec 2024 23:37:46 GMT

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