Director, Clinical Operations - Startup Biotech - Home based job in London, England

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Job type: Permanent

Discipline: Program Manager / Director

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

A start-up oncology Biotech in the UK are looking for a Director, Clinical Operations to join their team as the 1^st Clinical hire to build out their Clinical Operations. This is a permanent, home based opportunity where you'll be joining at a significant period of growth to bring their studies into clinic by 2024. This is a truly amazing chance for someone with strong early phase oncology start up experience who wants to make a different in the oncology space.

You'll be required to build out their processes from the ground up and to manage their CROs/ Vendors that they're currently in the process of selecting. Some occasional travel (one time per month) into their UK offices will be needed.

What's on offer? A highly negotiable basic salary + share options upon joining.

Responsibilities

Lead clinical operations and work with clinical development advisor (CMO) on strategic planning activities.
Identify the resource needs for implementation of operational plans.
Provide strategic planning and feasibility analysis for site selection, contract negotiations and patient recruitment programs.
Manage clinical trial implementation with clinical sites, external consultants and CRO personnel to ensure timely implementation of clinical studies in accordance with GCP regulatory requirements.
Interact with investigators as warranted to obtain necessary documentation and information before, during and after the study.
Prepare and present at investigator meetings to ensure that the clinical and investigational site staff team is well informed about the study and related procedures.
With CRO partner, conduct pre-study site visits to assess the willingness and suitability of potential clinical sites.
Manage the maintenance of regulatory documentation from clinical sites and investigators required for the initiation and continuation of clinical studies; manage patient accrual, screening and enrolment information from sites.
Oversee the operational selection of various vendors and the review of proposal requests.
Work with clinical development advisor (CMO) and external advisors with regards to clinical study operational issues including safety reporting and processing, study drug supply plans, cross-functional communication/interaction plan and monitoring.
Manage progress of clinical studies and ensure adherence to the protocol, timelines, and budget. This includes reviewing site recruitment, initiation and patient enrolment progress and reviewing and acting on trending reports.
Develop and manage clinical trial budgets; proactively provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner.
Collaborate with the CMO to generate high quality clinical study reports, investigator brochures, clinical protocols, publications and presentations of clinical study results.
Prepare, coordinate and maintain clinical sections for regulatory submissions.

Qualifications

Position requires a Bachelor of Science degree and at least 10 years of experience in the clinical development & management of clinical operations function. Experience participating in international clinical studies required.
Experience working in a small startup biotech setting is a 'must have'. Higher degree (i.e. PhD, PharmD, MPH, MBA, etc) is desirable.
Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
Therapeutic area experience in oncology is highly desirable.
Strong understanding of ICH guidelines, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials.
Excellent verbal and written communication and presentation skills.
Excellent leadership and interpersonal skills with an ability to effectively work within a multidisciplinary team, provide mentorship to team members and to effectively manage multiple vendors. Ability to efficiently manage direct and indirect reports including remote staff.
Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in small company environment.
Ability to proactively identify challenges, possess strategic foresight and implement appropriate courses of action.
Proven track record of successfully delivering projects on time, to budget and at the required quality.
Demonstrated ability to effectively negotiate contracts and financial terms.
Successful track record in managing Phase I and, Phase II global clinical trials. Experience leading pivotal studies is a plus.
Willingness to travel as necessary, consistent with study needs.

If you are having difficulty in applying or if you have any questions, please contact Jack O'Neill at +44 203 8460 646.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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