Discovery Medicine Group Leader

Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Oct 7 2022

Discovery Medicine is a clinical/translational organisation accountable for providing a rigorous assessment of the therapeutic potential and clinical tractability of targets, and for clinical leadership in defining and executing an optimal, innovative early development strategy. The Discovery Medicine Leadership Team is based in Stevenage, UK and UP, US and includes Discovery Medicine Group Leaders reporting to the VP, Head of Discovery Medicine.

The Discovery Medicine Group Leader is recognised internally and external to GSK as a leader in Drug Discovery, Early Development and Translational Medicine and/or as an expert in his or her disease/therapeutic area.

You will lead, mentor, and develop an experienced and talented team of physicians and clinical scientists within Discovery Medicine (DM) and engage as an active and critical member of the DM leadership team.

You will have a thorough understanding of the asset(s) you are working on, the biological mechanism(s) of action and relevant disease indications. Accountabilities will include provision of medical and scientific input into the design of one or more clinical studies within Clinical Pharmacology and Experimental Medicine (CPEM) and clinical leadership to the Research Units relating to specific diseases, target discovery and validation as well as development feasibility and potential strategies for early clinical development of compounds prior to candidate selection. You will be responsible for design and delivery of the early Clinical Development Plan (CDP), working with the Early Development Lead (EDL), project team and study teams, to deliver data that will support progression to full development of the medicine.

The Discovery Medicine Group Leader will also provide clinical support/leadership for proof of mechanism studies (POM) for compounds in Development. You will be accountable for medical governance and regulatory reporting at the project level (and in support of the Clinical team) through clinical interpretation of data (clinical and non-clinical) that can impact patient safety and clinical efficacy.

To succeed in the role, you will be a talented and experienced senior leader with a proven ability to think and plan strategically, work closely with a broad matrix team of project representatives and in some cases, external collaborators, and should have well developed leadership and stakeholder management skills.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Strategy, Line and Matrix Leadership

• Accountable for design and delivery of an early clinical development and translational strategy that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development
• Accountable for life cycle innovation strategy for targets in the portfolio including potential indication expansion
• Accountable to provide input on indication selection for target discovery
• Line management responsibilities for a team of 6-8 Discovery Medicine Physicians and Clinical Scientists
• Lead the Clinical Matrix Team (CMT) (or equivalent cross-functional clinical team)
• Serve as a member of the Discovery Medicine Leadership Team
• Accountable for engaging external academic and clinical experts to enhance quality and delivery of discovery medicine studies

Medical Governance

• Accountable for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other GSK activities/functions impacting safety and efficacy (i.e. manufacturing, formulation, etc.)
• Accountability for providing clinical input into presentations, supporting documentation for and participation in governance meetings
• Accountable for escalation of clinical safety incidents to the Discovery Medicine head, as appropriate
• Study design, protocol development, execution and reporting

Safety

• 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 and risk/benefit sections of 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 Development Safety Update Reports (DSUR’s) and IB updates

Other

• Transition to Development organisation- Interactions with Medicine Development Lead and Clinical Development Lead for smooth transition of programmes
• Patient perspective – accountable for incorporating patient perspective in the design and conduct of DM studies

Leadership

You will be highly experienced in drug development and translational medicine. You will be expected to work across multiple Discovery Medicine projects, demonstrating independent accountability 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.

You will play a leadership role in

• 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 in Discovery Medicine
• line management responsibilities within Discovery Medicine including recruitment, setting objectives, driving performance, and building development plans
• mentoring and coaching other members of Discovery Medicine
• applying extensive knowledge of clinical development to more than one research unit/disease area
• building an external network with academia/pharma, bringing 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

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

– MD (Board Certified or Eligible) and preferably PhD with demonstrated broad clinical and/or drug discovery and development experience

– In-depth experience in translational medicine and drug development is required (Research & Development)

– Experience of setting and executing scientific strategy, whilst being mindful of overall company goals

– Track record in taking assets from lead optimisation to candidate selection and FTIH

– Understanding and knowledge of early development, e.g. DMPK, biomarkers, etc.

– Experience in working with relevant regulatory bodies and professionals in early stage discovery and development

– Excellent presentation, influencing and media skills for both internal and external audiences.

– Outstanding people management and development skills

– Ability to lead and contribute to a global cross-functional team of senior leaders

If you have the following characteristics, it would be a plus:

– Experience in business development and assessment of external in licensing and due diligence activities

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, rigour and risk, governance and control, managing ambiguity and paradox.
• Managing individual performance.
• Creating a performance culture and driving results, prioritisation, execution, delivering performance.
• Setting strategic direction and leading on-going organisational transformation.
• Building a resilient organisation.
• Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
• Managing P&L and capital allocation.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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