SVP Medical Affairs

SVP Medical Affairs

Discover International | UK, UK, UK

Posted 13 days ago

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• The role will be initially concentrating on building and leading a medical affairs team focused on mAbs used for treatment of a rare disease (it may expand into other rare diseases in the future).
• The role will involve significant collaboration with our Client’s alliance partner, and also with the internal teams to ensure successful late-stage development, launch and life-cycle management of the mAbs.
• The SVP will develop and execute our Client’s Medical Affairs plan and have responsibility for the Medical Affairs strategy.
• The SVP will be expected to represent our Client at speaking engagements and in regulatory interactions with the agencies, and will be building relationships with Key Opinion Leaders and patient groups.
• The Medical Affairs organization will play a key role in the establishment of centers-of-excellence for diagnosis and management of a rare disease and will be a critical resource for health care providers.

Key responsibilities
• Leader of Medical Affairs Department, responsible for its strategy.
• Provide medical and scientific leadership/expertise on the cross?functional mAbs team.
• Serve as an ambassador of Medical Affairs to interact with external and internal stakeholders.
• Internal collaboration to advance the medical aspects of Client’s Medical Affairs activities, with a focus on the launch of the mAbs.
• Grow Client’s network of key scientific advisors and collaborators.
• Drive creation and oversee the execution of programs, plans and strategies (comprehensive medical launch plan that is aligned with the brand plan; medical education and outreach programs to facilitate disease-awareness and rapid diagnosis of rare disorders; publication plan, KOL/Advisory Board Plan, Grant Plan etc.)
• Be accountable for data generation execution, tracking and management of delivery and ensuring efficient use of resources (working closely with CRO and Clinical Operations Department)
• Internal collaboration to develop and reimbursement strategies to optimise the value of mAbs, and to help assess CMC / Manufacturing needs / activities, ensuring readiness for launch with aligned strategic development of processes for recall, medical information and pharmacovigilance.
• Ensure adherence to GCP as required in real world evidence generation and all applicable local and international regulations (working with the Head of QA)
• Representing the Client on key Regulatory interactions with European Regulatory bodies (EMA, MHRA etc.)
• Point of contact with Client’s alliance partner and member of joint committees of the collaborative partnership.
• European launch readiness

• At least 12 years’ experience in a medical department of a pharmaceutical or biotech company, (preferably rare diseases and orphan drugs; late stage clinical development in a small company environment would be ideal)
• Strong background in Medical Affairs in Europe (late stage development, launch phase).
• At least 10 years’ experience of working at an international level with proven track record of successes in achieving company’s objectives across geographic, organizational and functional boundaries.
• Ability to summarize scientific data and concepts
• Thorough understanding of industry medical governance norms, with particular reference to compliance with all laws and regulations (including EFPIA codes of practice)
• General Medical Council UK registration
• Hospital experience as practicing doctor

Required Skills
• Building a Medical Affairs team in Europe experience (ideally for rare diseases)
• Strong communication skills; effective communication across multiple media (teleconferences, presentations, meetings and written communications)
• Successful delivery of Scientific communication and medical publications processes
• Proven track record of engaging and influencing stakeholders with integrity and transparency
• Ability to deliver a business plan as a member of cross-functional team
• Experience with medico-legal review principles / processes
• Demonstrated understanding of Medical information and Pharmacovigilance practices in Europe