Working independently, the Medical/Scientific Director is capable of fully leading designated aspects of the Medical Affairs strategic planning process and its implementation on behalf of the Oncology Regional Medical Affairs Head and in collaboration with her/his peers and other functions in the medical affairs team. This may include the following activities:
- Plays an integral role in contributing the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for the relevant asset/indication(s).
- Drives delivery of designated above-country elements of the MAP, e.g., Advisory Boards, Symposia, Medical Educational Events, Scientific Platform.
- Partners with commercial colleagues to optimize brand strategy, campaigns and launches in the Local Operating Companies (LOCs).
- Leading and overseeing partnerships from a GMA perspective for the relevant asset/indication(s).
- Drives the development and/or approval of educational, training and other materials and responses.
- Drives the regional congress planning and coordination from a brand perspective, including pre- and post-congress deliverables and supporting LOCs in local congress execution.
- Drives the scientific training coordination and execution from a brand perspective,
- Delivers the evidence needs for that asset in partnership with R&D
- Drives excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
Key Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Gathers medical insights from the Local Operating Companies (LOCs) and external stakeholders (HCP’s, Patients, Payors and Regulators) to shape the integrated evidence strategy and global medical affairs plans and strategy.
- Drive medical lead research activities including Expanded Access Programs
- Leads Advisory Board, Symposia and other Educational Activities design and discussion ensuring compliance with SE governance and documentation requirements.
- Inputs to the design and delivery of phase IIIb/IV studies and EAPs, including post-approval commitments, coordinating with relevant R&D technical experts.
- Facilitates preparation for the Brand Planning processes, ensuring compliance with timelines and mandated global templates to ensure consistency across LOCs.
- Develops/reviews publications/abstracts/posters related to the product, key competitors, and relevant disease area(s). Ensures the Data Dissemination Plan (DDP) is maintained.
- Supports the regional head in communicating effectively the clinical and market access data for their asset to the LOCs; ensures a robust understanding of risk: benefit.
- Enhances local tactical plans and shares best practices to support Launch Excellence.
- Supports the in providing medical governance oversight for the asset, including management of product-related issues with potential impact on patient safety, and medical budget management.
- Drives excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
- Responsible for successful delivery of Global Integrated Medical Affairs Plans, Medical (Pre)Launch Plans, and Integrated Evidence Plans (IEP) for the relevant asset/indication(s) in accordance with GSK and statutory requirements.
- Responsible for driving internal scientific training coordination and execution from an asset perspective, including material development and/or approval in accordance with GSK and statutory requirements.
- Responsible for driving excellence in external engagement - building credibility with, and insights through, a strong external network.
- Ensures appropriate medical governance including the management of product-related issues with potential impact on patient safety.
Why you?
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
- Medical Doctor-Board Certification, PhD or PharmD
- Minimum 8 years of experience in medical affairs
- Minimum 5 years of Industry or clinical experience in the oncology therapeutic area.
- Broad drug development experience with robust knowledge of GCP regulatory/ market access.
- Experience in developing, designing and implementing expanded access program studies.
- Significant experience in Global / Regional Medical Affairs and life cycle management, including launch.
- Robust understanding of promotional codes/regulations; previous involvement in review and approval processes.
- Demonstrated ability to build strong internal and external networks.
- Ability to work across time zones and to travel.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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