Title: Head, EU Medical Affairs
Reports to: Vice President, Medical Affairs
The Head EU Medical Affairs will be responsible for the development and execution of overall Medical Affairs strategy in EU. He/she will provide leadership and planning for EU Medical Affairs activities including disease education, regional and local scientific exchange, medical science liaisons, and operations. The Head, EU Medical Affairs will initially serve as primary lead in determination and review of global scientific materials to adapt for specific EU medical needs. They will establish and lead regional and country level medical capabilities including Country Medical Directors and MSLs. The candidate will be expected to thrive in a fast paced, dynamic, and nimble environment with needs for managing external vendors/consultants.
Roles and Responsibilities
- Build and lead the European Medical Affairs organization to the successful development, launch and commercialization of the company’s drugs, establish regional and local operations infrastructure coordinating closely with Sage leadership.
- Develop innovative, consistent, and clear EU medical strategy for by representing and integrating local country patient and healthcare provider needs into development of global medical plans
- Inform and collaborate with medical and scientific opinion leaders (i.e. EMA, NICE, KOLs, guideline-making organizations).
- Works in close coordination with Head of Europe and Global Medical Affairs to inform, develop and align global, regional and local medical activities
- Collaborate in support of Clinical, R&D, HEOR, Commercial, and Regulatory activities in support of healthcare technology assessment and local market needs
- Ensure quality, accuracy, objectivity, relevance and effectiveness of medical and scientific materials, information, and data used in communicating with HCPs, advocates and regulatory authorities in EU
- Provide therapeutic area expertise and medical input into the formulation of the overall development and global commercialization strategy.
- Establish strong relationships with EU KOLs and patient advocacy organizations.
- Work with regional and local healthcare authorities to drive changes in treatment care pathways.
- Provide medical leadership into the development of a communication and publication strategy, including overseeing the medical content of all materials such as publications, manuscripts, abstracts, posters, education, marketing, etc.
- Ensure that content of EU Medical Symposia Congress presentations are accurate, strategically focused, and compliant.
- Provide medical review for country specific medical information responses and letters for healthcare professionals, and the review of marketing materials.
- Develop and implement a strategic staffing plan for EU Medical Affairs activities and the MSL team.
- Develop and implement Medical Affairs training and programs in preparation for product launches and ongoing education needs.
- Represent the company at EU medical meetings, advisory boards, outreach meetings at key institutes, and in interactions with KOLs.
- Monitor and oversee safety, including the ongoing safety signal detection for the clinical programs.
- Thoughtfully develop and manage EU medical affairs budgets and grants spend in support of strategic needs.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- This position requires a medical degree and 10+ years bio/pharmaceutical industry medical affairs experience
- Must possess strong strategic leadership attributes and ability to build consensus among differing stakeholder groups.
- Experience building, leading, and developing high performance teams in Europe; a minimum of 10-15 years in senior leadership roles.
- Must possess excellent communication skills, relationship building capabilities, and proven ability to influence decision-making without authority.
- Must be willing and able to travel and regularly meet with KOLs, regulatory authorities, and patient advocacy organizations in EU as necessary to achieve medical objectives
- Must be highly perceptive, socially intelligent and intuitive
- Leadership skills, including a passion for working within multiple teams and proven ability to achieve results in a matrix organization.
- Highly prefer previous Experience in Neurology, Psychiatry and or Women’s Health
- Experience in leading pre-launch, launch, and post-launch activities for a new, first-in-class, or otherwise innovative product is a plus
- Knowledge of the drug development process; strong understanding of technical, business, and regulatory issues. Experience in clinical development is a plus
- Be a diplomatic professional, ‘clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and brining medicine to patients
- Highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company