Scientific Director- Nucala, Open to flexible working
This is an exciting opportunity for an accomplished medical affairs scientist, with a track record of success, to lead the successful delivery of medical affairs activities to drive Nucala. This individual must have US or Global medical affair experience and s/he will partner with the VP, Global Medical Affairs on the following:
- Contributing to the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan for Nucala
- Lead and drive ABPI signatory work
- Leading to designated elements of the above-country MAP e.g. Advisory Boards; Symposia.
- Partnering with commercial colleagues to develop brand campaigns and support launches.
- Developing and approving promotional, non-promotional and training materials.
- Delivering the evidence needs of that asset in partnership with Franchise/ R&D colleagues, including:
- Supporting the efficient working of the Integrated Evidence Team;
- Reviewing local GSK-sponsored and Investigator Sponsored Study (ISS) proposals to assess their scientific merit and strategic need;
- Driving excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs
- Driving TA publication strategy and scientific communication to build out scientific evidence platforms
Key responsibilities include:
- Supports the VP, Global Medical in gathering medical insights from the Franchise LOCs and external stakeholders (HCP's, Patients, Payors and Regulators) to shape the integrated evidence strategy and plan
- Leads aspects of Advisory Board design and discussion, ensuring compliance with SE governance and documentation requirements (SE Approval Templates; GLASSES etc).
- Inputs to the design and delivery of phase 3b/ 4 studies, coordinating with relevant R&D technical experts e.g. Value Evidence Outcomes and Epidemiology as required.
- Supports preparation of materials for the governance review/ Brand Planning processes.
- Develops and approves promotional campaigns and materials, ensuring compliance with all relevant codes and system requirements (ABPI, Zinc MAPs etc).
- Develops and reviews publications/ abstracts/ posters related to the product, key competitors and relevant disease area(s). Ensures the Data Dissemination Plan (DPP) is maintained in Datavision.
- Supports the VP, Global Medical in communicating the clinical and market access data to the Franchise LOCs, ensuring a robust understanding of risk: benefit of our medicines.
- Enhances local tactical plans and shares best practices to support Launch Excellence.
- Supports the VP, Global Medical in providing medical governance oversight for the asset, including the management of product-related issues/ crises.
We are looking for professionals with these required skills to achieve our goals:
- PharmD, PhD or equivalent
- US or Global Medical Experience
- ABPI experience
- Broad drug development experience with robust knowledge of GCP regulatory/ market access and reimbursement requirements.
- Ability to develop, design and implement Phase 3b /4 studies.
- Significant experience in Medical Affairs and life cycle management preferred, including understanding of launch support requirements.
- Robust understanding of promotional codes/ regulations; previous involvement in review and approval processes.
- Highly developed leadership, networking, communication and influencing skills to work effectively in a complex matrix environment.
- Demonstrated ability to build strong networks of external and internal experts
- Self-motivated with the ability to work independently and as part of a highly matrixed team with minimal supervision.
- Strong critical thinking.
- Excellent written and verbal communication skills.
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, 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.
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