Director Discovery Medicine Physician, Open to flexible working

Location
Stevenage, Hertfordshire
Salary
£Competitive
Posted
12 Oct 2021
Closes
02 Nov 2021
Ref
307624
Contract Type
Permanent

Discovery Medicine is made up of the physicians and clinical scientists within the Research organisation, which is the organisation in GSK responsible for non-oncology, early-stage pharmaceutical R&D. The group contributes deep scientific expertise in translational medicine and early clinical development as well as broad medical expertise from board certified physicians across multiple therapeutic areas.

The Discovery Medicine group is responsible for the rigorous assessment of clinical tractability and therapeutic potential of new targets. In addition, the group is accountable for strategic translational plan and the design of early clinical studies, with an emphasis on using early development to increase confidence for investment into Phase 2 clinical proof of concept studies.

Position Summary

The Director Discovery Medicine will be recognised internally and external to GSK as a leader in Drug Discovery, Development and Translational Medicine and/or as an expert in his or her disease/therapeutic area.

You will have a thorough understanding of the asset(s) you are working on, including their biology, and of relevant disease indications. You will be accountable for, among other things, the provision of medical and scientific input into the design of early-stage clinical studies (e.g. first time in human and proof of mechanism) and for clinical leadership in target discovery and validation. Prior to candidate selection this includes evaluating clinical indications, development feasibility and potential strategies for early clinical development for targets/compounds. Following candidate selection, you will be responsible for design and delivery of the early Clinical Development Plan (CDP), working closely with the Early Development Leader (EDL), project team and study teams to deliver data that allows a robust decision to be made on the full development of the medicine.

The Director Discovery Medicine will also provide clinical support/leadership for mechanistic studies of marketed compounds or those already in late stage development. You will be accountable for medical governance and regulatory reporting at the study and project level for the assets you are working on, including clinical interpretation of data (clinical and non-clinical) related to patient safety and clinical efficacy.

To succeed in the role, the successful candidate will need to work closely with a broad matrix team of project representatives and in some cases, external collaborators.

The responsibilities of the Director Discovery Medicine include (but are not limited to) several key areas:

Strategy and Matrix leadership

  • Works closely with research members to define the best clinical indication(s) for a target and integrates inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to the Early Medicine Profile;
  • Accountable for the design and delivery of an early clinical development plan that efficiently demonstrates proof of mechanism, potential for clinical efficacy, and initial safety profile to support a decision on progression to full development of a compound.
  • Lead the Clinical Matrix Team (CMT) (or equivalent cross-functional clinical team)
  • Accountable for identifying and engaging external academic and clinical experts where necessary to enhance the quality and delivery of discovery medicine studies.
  • Accountable for providing clinical input into preparation for, and discussion at GSK Governance boards.

Clinical study design

  • Provides expert clinical input into study design, protocol development, execution, analysis and reporting.

Medical governance and Study Safety

  • Accountable for Medical Governance within a project, including ensuring the scientific integrity and overall safety of study participants and for input into other non-study GSK activities/functions insofar as they may impact safety and efficacy (i.e. manufacturing, formulation, etc.)
  • Accountable for escalation of clinical safety incidents to the Discovery Medicine head, as appropriate.
  • Accountable for providing oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Physician, providing input into aspects of study design that relate to subject safety.

Regulatory

  • Accountable for clinical input to regulatory documentation to support the desired indication (e.g., IB, IMPD)
  • Responsible for addressing clinical questions at meetings with regulatory authorities/ethics committees
  • Accountable for regulatory reporting requirements including clinical elements of Development Safety Update Reports (DSUR’s) and IB updates

Other

  • Transition to Development organisation – interacts with incoming Medicine Development Leader and Clinical Development Leader for smooth transition of a programme from Research into the Development organisation.
  • Patient perspective – accountable for incorporating patient perspective in the design and conduct of DM studies

Leadership

You will be highly experienced in drug development or translational medicine. You will be expected to work across multiple projects in Discovery Medicine and be independently accountable for your own projects. You will set long-term scientific strategy and be capable of executing this strategy based on your own expertise and that gained from your network.

Opportunities for leadership include

  • medical governance initiatives in R&D (e.g. safety panel or governance board)
  • discovery/development policy, processes or guidelines affecting the pharmaceutical industry
  • training networks in/outside of GSK
  • business development activities representing Discovery Medicine
  • mentoring and coaching other members of Discovery Medicine
  • applying extensive knowledge of clinical development across multiple disease areas
  • building an external network with academia/pharma, and bringing this expertise and knowledge back to GSK
  • anticipating, communicating and acting on trends/events outside GSK that affect our business direction
  • utilising command of the drug discovery and development process to influence a culture of continuous improvement

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Primary medical qualification (and GMC registration)PhD (or equivalent) and a clinical specialty qualification (e.g. CCT or equivalent).
  • Significant immunology experience.
  • Experience in an industry or academic context in translational medicine and early phase drug development, including experience in the design and analysis of early phase clinical studies.
  • Experience of setting and executing scientific strategy, whilst being mindful of broader clinical or company context.
  • Understanding and knowledge of genetics (and its potential in early drug development).
  • Experience in working with relevant regulatory bodies and professionals in early phase discovery and development
  • Excellent presentationinfluencing and media skills for both internal and external audiences.
  • Ability to lead and contribute to a global cross-functional team of experts.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigor and risk.
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.

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.

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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