CUC (Clinical Unit Cambridge) Physician Director

Employer
myGwork
Location
UK
Salary
Competitive
Closing date
11 Jun 2022

View more

Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Site Name: UK - London - Brentford
Posted Date: Feb 17 2022

Position Summary

Discovery Medicine comprises physicians and clinical scientists within the Research organisation. The group has deep scientific expertise in translational medicine and early clinical development combined with a breadth of medical expertise from board certified physicians across multiple therapeutic areas.

The CUC Physician Director is highly experienced in drug development or translational medicine, with appropriate experience in clinical pharmacology in early phase I/II studies, commercial or academic. It is expected that they will have a good understanding of pharmacokinetics and pre-clinical toxicology. They will also act as Principal Investigator on FTIH studies.

Therefore, the CUC Physician Director provides senior management and support for all medical activities at the GSK Clinical Unit Cambridge (CUC). The post holder will be required to:
  • uphold and provide oversight for the safety and quality governance of all research activities at the CUC through provision of medical leadership (reporting into the Medical Director who has overall accountability).
  • lead and work alongside a multidisciplinary research team at the CUC to deliver high quality clinical care during the conduct of clinical trials of investigational medicinal product/s and experimental medicine studies.
  • provide leadership for integration of medical and scientific expertise of the CUC into study plans and protocols, working closely with members of the central GSK team to deliver high value and innovative studies.
  • represent the CUC both internally and externally, and where needed act as broad liaison with non-GSK co-development partners (including but not limited to Addenbrooke's NHS Trust, University of Cambridge academic personnel, Wellcome Trust Clinical Research Facility).
  • have accountability for maintaining the necessary capabilities and skills of reports.
  • regularly reviews planned workloads to ensure resources are appropriately forecasted and applied.
  • represents the clinical research team at the CUC leadership team, as required.
  • have line management responsibility for the CUC team of Clinical Research Physicians and Clinical Research Physician Associates, as required.
  • ability to delegate for CUC Medical Director, as required.

This role requires competent IT, excellent interpersonal and advanced leadership skills to effectively manage study teams for quality, and on-time and on-budget delivery of clinical trials. Working with central GSK teams on early clinical development and translational medicine.

Key Responsibilities

Study delivery and conduct
  • Leads and works collaboratively with the CUC staff and central GSK team members to ensure delivery of high quality and safe clinical trials in healthy volunteer and patient populations.
  • Builds effective networks, within and outside GSK whilst promoting a professional and positive image of the CUC both internally and externally. Working closely with members of the EDT, to provide CUC expertise into the medical and scientific aspects of study plans and protocol.
  • Acts as co-Investigator or Principal Investigator (PI) on clinical studies, including and not limited to clinical pharmacology studies, experimental medicine studies and First-Time-In-Human (FTIH) studies.
  • Co-ordinates the clinical research team on protocol-related activities, including (but not limited to) supporting participant recruitment, obtaining informed consent, medical screening, performing ongoing monitoring and post-study clinical examinations, review and interpretation of vital sign, ECG, spirometry, Holter and laboratory test results.
  • Co-ordinates the clinical research team on study specific and diagnostic/therapeutic procedures, e.g. venepuncture, cannulation, suction blisters, punch biopsies, ECGs and assist with their processing. With the ability to demonstrate/train the clinical research team in technical skills required during study conduct to aid innovative approaches to drug development.
  • Co-ordinates and provides flexible support for clinical activities on an as needed basis.
  • Co-ordinates the clinical research team on safe dosing of study medication including investigational medicinal products (IMPs) and non-IMPs, through all routes of administration, e.g. oral, intravenous, subcutaneous.
  • Responsible, for ensuring complete medical cover is provided for recruitment of volunteers and patients, during study conduct, and study follow-up. This includes coordination and provision of medical cover outside normal working hours as defined by the study protocol or Medical Director, or as deemed appropriate in an emergency.
  • Responsible for the on-call out of hours cover, and provides cover on a rota basis, in conjunction with the other physicians.

Safety
  • Responsible for medical safety and governance decisions, and escalating these to the Principal Investigator, Medical Director, and Medical Monitor where appropriate.
  • Develops strategies to anticipate and expertly manage medical safety issues, including emergencies.
    • Management of adverse events and medical emergencies.
    • Follow-up and reporting of adverse events and communication/escalation of safety issues, as appropriate.

Other
  • Co-ordinates the clinical research team to ensure compliance with acceptable medical standards and the requirements of the protocol, standard operating procedures, ICH GCP, Research Ethics Committees (RECs), regulatory authorities and other applicable guidelines and regulations.
  • Responsible for the clinical research team to ensure the maintenance of accurate research records and notes (source documentation), with data entry into paper or electronic databases as required.
  • Maintains knowledge and proficiency in medical practices (e.g. ALS certification), through continued professional development.
  • Responsible for ensuring the Physicians and Physician Associates are up to date with all training requirements and continued professional development, as well as providing senior medical input into the development of the multi-disciplinary staff at the CUC through teaching/training/supervision where appropriate.
  • Responsible for the clinical research team to ensure that standards are maintained to enable the delivery of consistent high quality and safe clinical trial conduct, at the CUC, through relevant audit and quality improvement and governance activities
  • Accountable for authoring (where required) and reviewing and approving the Informed Consent Form (ICF) and relevant Research Ethics Committee (REC) submission documentation.
  • Accountable for responding to questions from RECs, and regulatory authorities as required.

Candidate Profile

Experience and Qualifications

Expected
  • MBBS or equivalent with Full registration with UK General Medical Council with a licence to practise.
  • UK trained doctors: at a minimum, will have completed their early Specialty or General Practice training (Postgraduate Membership of a Royal College is desirable) and have relevant acute medicine experience.
  • Doctors who have trained outside of the UK, will be able to demonstrate equivalent qualifications and experience of clinical practice in acute care of patients.
  • Considerable experience in clinical pharmacology in early phase I/II studies, commercial or academic.
  • Principal Investigator on FTIH studies.
  • Good understanding of Pharmacokinetics and pre-clinical toxicology.
  • Commitment to train toward and/or the Advanced Life Support Provider (as a minimum) qualification of the UK Resuscitation Council (UK).
  • Strong verbal and written communication skills.
  • Excellent interpersonal skills and energy to operate in a complex organisation environment.
  • Ability to maintain and develop relationships and networks with different communities.

Preferred
  • Diploma in Pharmaceutical Medicine or other relevant postgraduate qualification (e.g. Diploma in Human Pharmacology) is desirable.
  • A post graduate qualification, such as PhD or MSc in a relevant life science is desirable.

Core Competencies
  • Leadership capability - demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities.
  • Strategic Thinking - maintains competitive advantage by carefully considering the issues and competing priorities within a situation, program or portfolio and then developing a strategy that includes the strategic application of available principles, tools and systems.
  • Business Acumen - Understands the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D.
  • Project Management - Demonstrates the discipline of risk-based planning, organising and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.

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