Director, Global Medical Affairs – Seasonal Influenza Vaccines
- PhD or PharmD is required.
- 8+ years recognized experience and expertise in medical affairs and teamwork. Ideally includes experience managing external experts and interacting with EE's and organizing activities involving EEs
- Knowledge of the Pharmaceutical and/or Vaccine Industry; broad understanding of the different disciplines involved, with a sound knowledge of life sciences & vaccination: vaccines, infectious diseases, immunology, preventive medicine and public health.
- Clear understanding of the ethical, regulatory, compliance and legal framework which underpins all of GSK's interactions with the external environment; knowledge of the issues that face Pharma Industry with respect to interactions with External Experts
- Scientific and medical knowledge/expertise in designated disease/product area acquired through education, readings, daily work, attendance to meetings (internal and/or external), and attendance to congresses.
- Basic knowledge of budget and account management
- English fluent.
- Medical Doctor preferred
- Local affiliate experience (LOC) is considered as an asset
- Specialty in immunology, infectious medicine, epidemiology or other relevant specialty is considered an asset
- Languages other than English are an asset.
- Proficient in using a PC and common software packages (Word, Excel, Powerpoint).
GSK is a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare.
Our Vaccines business is one of the largest in the world, producing pediatric and adult vaccines against a range of infectious diseases.
At GSK Vaccines, we employ over 12,000 people worldwide, including more than 8,000 at our global headquarters in Belgium. Almost a quarter of our staff work in research and clinical development, inventing new and innovative vaccines against some of the world's most serious infections and diseases.
- Ensures global medical affairs leadership for a vaccine in life cycle and development with a consolidated medical voice into R&D and commercial
- Responsible for the vaccine access strategy with a patient centric mindset
- Contributes with the medical voice in the Global Clinical Development plans for products in development and in Post-marketing and vaccine plans, aligned with the Access Stream and VDT/VCT overall strategy
- Co-Lead with the Lead Global Medical Affairs Leader (L-GMAL), the development and implementation of the Global Medical Affairs Strategy supporting the launch optimization of the seasonal influenza vaccines: Fluarix™ and Flulaval™ quadrivalent/tetra vaccines in the identified key countries, and prepare the launch of the new 6-months indication in US and international by providing Medical expertise, market access focus and insights to cross-functional teams within the organization.
Knowledge and application of the GSK Code of Practice, Scientific Engagement and applicable Policies and SOPs in all areas of Medical Affairs.
- In collaboration with the L-GMAL, constructs Medical Plans (MPs) , building input from global gap analyses, Region, key LOCs (Local operating companies) input, and stakeholder and customer input (external and internal)
- Ensures integration and alignment of relevant global, regional and local Clinical, Epidemiology and Health Outcome activities and provides medical support / advice in collaboration with the L-GMAL to these plans
- Delegate of the L-GMAL, in external and internal meetings and/or governance
- Chairs and drives the Access Stream for influenza assets and representing the medical voice; this includes ensuring insights from regions and LOCs and key external stakeholders (vaccine recipients, physicians, payers, regulators). Responsible for the alignment of access activities with processes to identify, generate medical, epidemiological, clinical (including investigator sponsored studies) and health economic outcomes and research data to create value and ensure proactive engagement with key internal and external stakeholders in line with customer needs
- Accountable for the phase 3b and 4 studies, including post-approval commitments, and investigator sponsored studies that supports the evidence needs of delivering or expanding the value proposition in line with customer needs
- Responsible for working in partnership with clinical development and central and regional partner functions, to optimize the clinical development plans in support of a reimbursable file and life cycle strategy.
- Drives the medical communication strategy for the product(s) including long term communication / publication planning
- With the L-GMAL, represents the scientific/medical voice with scientific experts, HCP, policy makers
- Ensures that medical/ scientific communications are scientifically sound and aligned with strategy from a medical perspective
- Critically appraises, review and recommends changes to publications, commercial and clinical documents for alignment to strategy, clarity of messages and scientific accuracy.
- Agrees the execution of the External Expert Engagement Plan within the MP and implements the activities assigned in alignment with Scientific Engagement principles and relevant GSK policies and principles; external activities could include Advisory boards, External Speakers Programs, Medical education, Medical round tables, HCP meetings
- Demonstrates professional and ethical attitudes in External Experts (EEs) interaction and in EE development activities
- Implements (may lead the implementation through others) the agreed elements of the EE Plans, works in collaboration with the medical operations team, Regional and LOC medical teams, VCT and involving all stakeholders to define strategic needs.
- Builds and maintains excellent professional relationships with External Experts in full respect of Scientific Engagement Principles.
- Manage agency partners, including setting agency brief, as appropriate - this activity may be managed in part by Medical Operation Managers directly, depending on the service being provided and who is driving the content.
- Provides medical insights and leadership to cross-functional teams working on the assigned GSK product(s).
- Develops internal training material under supervision of the GMAL but with increasing independence and provides medical training at internal meetings for the relevant product(s) and therapy area(s) to GSK Regional/ LOC medical teams
- Expert knowledge of data and literature related to the product/project(s); identification of important publications for communication to medical network and project team, preparation of position papers, rebuttals, feed-back on literature selection
- Actively contributes to the development of Medical Affairs processes and harmonization activities
- Accountable for providing medical advice to commercial partners in the development of Key Claims and promotional material, ensuring in particular, balanced and proportional content, appropriately referenced, and aligned with product strategy.
- Conducts medical review and approval of promotional material in line with the Code of Practice and other relevant SOPs.
- Ability to analyses scientific data, (clinical, HE, Epi) and draw critical insights to understand how these address existing data gaps.
- Where critical gaps exist, ability to define these gaps in a manner that clinical, epidemiology and health outcomes partners can design appropriate studies to address.
- Ability to communicate complex technical data to a wide variety of audiences, including vaccine implementers, prescribers and global experts.
- Ability to identify the most appropriate paths of scientific communications that meet audience needs, and are consistent with GSK principles of Scientific Engagement
You may apply for this position online by selecting the Apply now button.
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