Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Jul 27 2021
Can you imagine yourself working in a high performing translational medicine department shepherding the next generation of medicines to address unmet medical need in patients across the globe?
The Discovery Medicine (DM) department within the Clinical Pharmacology and Experimental Medicine (CPEM) unit in the Research organization at GSK is comprised of physicians and scientists striving to deliver these medicines.
The DM Physicians and Scientists have deep scientific expertise in translational medicine and early clinical development and broad medical expertise across diverse therapeutic areas. They are recognized both within GSK and in the broader pharmaceutical and academic community as a leaders in Drug Discovery, Translational Medicine and Drug Development. Many are leading experts in their disease/therapeutic area of training.
The DM Physician Director is responsible for rigorous assessment of clinical tractability and therapeutic potential to inform the most appropriate development strategy for new targets in discovery. In addition, the Director is accountable for strategic translational plan and the design of early clinical studies to provide confidence to invest in Phase 2 clinical proof of concept studies.
You will have a thorough understanding of the assets you are working on, the biological mechanisms of action, and the relevant disease indications. Accountabilities will include provision of medical and scientific input and leadership to the Research Units' targets and assets. You will support target validation, development feasibility, and potential strategies for early clinical development of compounds prior to candidate selection. The leadership you provide will continue through development through accountability for the 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 Director, Discovery Medicine 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, the successful candidate will also need to work closely with a broad, global, matrix team of project representatives and external collaborators.
Location of the role
Upper Providence, Collegeville, PA
The responsibilities of the DM Physician Director include several key areas including but not limited to the following:
Strategy and Matrix leadership
- Works closely with research members to define the best clinical indication for a target and integrates inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Early Medicine Profile, Target Validation plans, and Candidate Selection
- Accountable for design and delivery of an early CDP that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development
- Lead the Clinical Matrix Team (CMT) (or equivalent cross-functional clinical team)
- Accountable for engaging external academic and clinical experts to enhance quality and delivery of discovery medicine studies
- Accountable for Medical Governance within a 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.)
- Accountable for providing medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Pharmacovigilance Physician, providing input into aspects of study design that relate to subject safety
- Accountability for providing clinical input into presentations, supporting documentation for and participation in governance boards
- Accountable for escalation of clinical safety incidents to the Discovery Medicine head and GSK Pharmacovigilance, as appropriate
- Study design, protocol development, execution and reporting
- 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
- Interactions with Medicines Development Leader and Project Physician Leader in the Development organization for smooth transition of programmes progressing out of the Research Organization
- Accountable for incorporating patient perspective in the design and conduct of DM studies
You will be highly experienced in drug development or 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 representing Discovery Medicine
- 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 expertise of the drug discovery and development process to influence a culture of continuous improvement
- DO , MD , or equivalent physician degree +/- advanced degree (PhD preferred)
- Immunology/Allergy training and experience: fellowship/certification preferred
- In-depth experience in translational medicine and drug development (Research & Development)
- Track record in taking assets from lead optimisation to candidate selection
- Experience of setting and executing scientific strategy, whilst being mindful of overall company goals
- Experience in Clinical Trials including early clinical development (FTIH, phase 1)
- Understanding and knowledge of early development (drug metabolism, biomarkers, etc.) across different modalities of agents (small molecules, biologicals)
- 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.
- Experience in networking with academic and research institution physicians and scientists
- Ability to lead and contribute to a global cross-functional team of senior leaders
- 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.
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.
- 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.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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