Head of Clinical Operations
Head of Clinical Operations
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Job Description
Job Title: Head of Clinical Operations
Job Location: Little Chesterford Saffron Walden CB10 UK
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level: Executive
Head of Clinical Operations
Chesterford Research Park – Cambridge
Permanent with a competitive salary and extensive benefits package
Never losing sight of our purpose
At 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 #TeamMestag
Scope of role
The 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 wellpositioned and wellfinanced cuttingedge 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 crossfunctional team responsible for timely high quality execution of trials
- Contribute to program strategy as part of a crossfunctional 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 researchrelated field highly beneficial.
- Extensive experience preferably in industry (Pharma biotech or CRO) in Phase 13 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 nonclinical activities.
- Proven track record in Phase 13 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 datadriven with excellent analytical and problemsolving skills
- Experience in a fastpaced entrepreneurial environment with an ability to multitask whilst maintaining attention to detail
- Flexibility and a willingness to do what needs to be done
In return we can offer you
- We 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 closeknit 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. However please submit your CV in the first instance via this link or via the Mestag Careers site. Unfortunately we cannot accept your cv via direct messages in LinkedIn.
About Mestag Therapeutics
Mestag harnesses new insights into fibroblastimmune interactions to develop impactful treatments for patients. We are progressing a pipeline of sophisticated firstinclass 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 stateoftheart instruments to enable our dedicated researchers to deliver incredible science.
Mestag is backed by committed leading global investors has worldclass 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
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Employment Type
Full Time
