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The Senior Medical Director, Global Medical Affairs, Neurology & Immunology is accountable for the development & execution of GMA’s Evobrutinib global strategic and tactical plans for the asset in the Therapeutic Area of Neurology & Immunology.
- Leads the Global Medical Affairs Team (GMAT) and is accountable for development of key GMAT deliverables for the asset, including unmet medical need assessment, scientific communication platform, external expert mapping and collaboration plans, scientific publication & congress plan, advisory boards, data gap analysis and post-approval data generation plans.
- Co-leads the cross-functional Global Launch Team with the Global Business Franchise asset lead and co-owns launch preparation and execution across functions. Ensures alignment of GMAT goals & deliverables with the integrated Launch Plan and overall Franchise Strategy.
- Represents the GMAT at the Global Program Team and ensures alignment of GMAT goals & deliverables with the integrated Development Plan. Provides valuable and actionable insights into clinical practice based on external insights that inform the development of the asset.
- Represents the GMAT in the collaboration with other internal stakeholders, such as Global Evidence and Value Development, Clinical Operations, Global Patient Safety, Therapeutic Innovation Platforms, Corporate Communications and Investor Relations.
- Enables generation of real-world insights into clinical practice, unmet needs and data gaps through various means including external expert interactions.
- Directs post-approval data generation (incl. Phase IIIb/IV, RWD, ISS areas of interest) based on real-world insights and unmet needs, reviews and approves protocols in the respective review committees.
- Enables scientific communication and collaborations with the external expert community. Serves as scientific/medical spokesperson for the asset throughout the life-cycle and presents on behalf of the project/program teams at relevant scientific conferences, industry events, advisory boards. Strengthens the team’s publication strategy, e.g. by supporting the generation of original manuscripts or review articles.
- Interacts with external stakeholders such as External Experts, investigators, patient advocacy groups, regulators, payers (as appropriate), potential development partners, investors etc.
- Sets goals, defines metrics and provide status updates on Global Medical Affairs programs to senior and executive leadership.
- Collaborates with other therapeutic areas to ensure consistent GMA interphase with key pan-therapeutic area partners.
- Provides disease state and medical affairs expertise in business development and due diligence activities.
- Trains/educates colleagues to deliver consistent and credible scientific statements.
Who You Are:
- MD with a relevant specialty and sub-specialty in Neurology and/or Immunology is preferred. PhDs and PharmDs with relevant research and pharmaceutical expertise in the Neurology and/or Immunology fields will be considered
- At least 10 years’ experience in pharmaceutical industry, preferably in Medical Affairs or Clinical Development in the area of Multiple Sclerosis
- Experience in development and successful execution of Global Medical Affairs plans or Global Clinical Development plans during development, launch and life-cycle management phases
- External scientific credibility in Neurology and/or Immunology field highly desirable
- Experience in clinical research protocol design, execution and publication. Ability to analyze, interpret, present and publish medical results
- Excellent communication skills, ability to present complex scientific data across a variety of expert and lay audiences and in a variety of settings (scientific peer settings and executive boardrooms). Ability to communicate in a precise, reliable, unambiguous and timely manner
- Strategic mindset with aptitude in translating strategy into tactics, setting priorities, making decisions and identifying and mitigating risk
- Proven ability to work effectively across functions and achieving results in an international matrix organization. Ability to define problems and seek alternate business solutions based on solid scientific judgement
- Business acumen Excellent inter-personal and influencing skills
- Cultural sensitivity and emotional intelligence
- High standard of ethical and intellectual integrity
- Excellent knowledge of Medical Affairs and Compliance industry practices internationally and in US
- Both international and US experience highly desirable
- Fluency in both written and spoken English is essential
- Management experience of direct reports preferred
- Willingness to travel as required up to 25%
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