Senior Director, Clinical Operations (UK)

Job Description

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com . The Senior Director, Clinical Operations, GRAIL Europe works in partnership with the Senior Medical Director and key functional leads to deliver a portfolio of large-scale clinical studies which are pivotal to GRAIL’s global evidence generation, regulatory and reimbursement strategy. You will assume responsibility for GRAIL’s UK-based clinical development strategy in support of diagnostic product development and lead the development and execution of large-scale clinical programs in alignment with GRAIL’s mission to detect cancer early. The role is based in London and reports to the President, GRAIL Europe.

Responsibilities Include:

• Lead 3 large-scale UK-based clinical programs, including one of the largest diagnostics trials ever initiated, in support of GRAIL's clinical development and commercial strategies
• Partner with the Senior Medical Director and key functional leads across the organisation to ensure alignment of strategy, objectives, and deliverables within each clinical program
• Be accountable for effective program management of clinical program deliverables, including study protocol and other study documents, contracts, timelines, and resourcing and risk management plans, and for communicating progress to teams globally
• Take overall responsibility for planning and implementing substantial clinical study budgets over multiple years, and for effective budget management and control
• Hold high-level relationships with multiple external stakeholders, including key clinical opinion leaders, to develop collaborations in support of GRAIL aims, serving as the focal point and where necessary negotiating optimal solutions among key strategic partners
• Be accountable for outcomes from partnerships and delivery of trial metrics, including ensuring enrolment targets are met and data are collected as planned, and for problem solving issues that arise in the European clinical programs
• Build confidence with study data monitoring committees, trial steering committees, and other study governance groups on study design, progress, metrics, and safety
• Partner with the technology teams to create and develop processes and applications for rapid capture of clinical data from external systems
• Play a key role in corporate development of methods, technologies and evaluation criteria for projects, programs and people
• Represent European clinical operations team in internal GRAIL initiatives, providing direction to project and program working teams
• Interact with senior leadership and major stakeholders to establish strategic plans and objectives for programs and projects, and to communicate program metrics
• Engage with study scientific advisory boards and other thought leaders to innovate and refine clinical development strategies and plans
• Apply principles, practices and standards that govern the industry and develop corporate and/or organisational policies and authorise the implementation of these policies
• Ensure full compliance with ICH GCP and other relevant regulatory requirements and that trials are conducted to Grail’s exemplary standards
• Build and nurture a high-performing team, including assigning and overseeing the activities of junior team members, facilitating their professional development and career growth and managing their performance
• Support the team to solve problems and learn from their mistakes
• Contribute proactively to building the culture and spirit of the UK-based GRAIL team, as part of the GRAIL Europe Leadership team and be a role model for GRAIL’s values

Experience & Expertise:

• Minimum Bachelor’s degree, preferably advanced degree
• Ideal candidate will have minimum 12 years of relevant experience
• Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience can substitute in part for IVD experience.
• Experience with building and leading teams and proven ability to collaborate and work cross-functionally to drive results in a matrixed, fast-paced environment
• Experience leading clinical research and clinical trials conducted in genomics, diagnostics, oncology, or other applied medical fields.
• Ability to travel (up to 20%).
• Proficient with office automation tools, such as Google suite of apps

GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected status. We want people from all walks of life to feel valued for their individuality, thrive in our business and share a sense of belonging. If you have a disability or special need that requires accommodation, please contact us . Apply for this job