Global Director Medical Affairs Biosimilars

Proclinical is seeking a Global Medical Director for a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. This Medical Director role will be a strategic and operational partner for different stakeholders within and outside R&D with a clear focus on being the link between Development and Commercial providing high quality medical affairs input and tactics for the successful acceptance and uptake of company biosimilars.

Job Responsibilities:

• To act as the global director for Biosimilars Medical Affairs activities covering in the first hand the compounds in 2 strategic TAs as assigned to the specific jobholder: AID and/or Oncology and develop medical affairs strategic plans for optimal pipeline launch and maintenance
• Provide the right operational toolkits to stakeholders for planning and implementation of the strategy. Ensure project budget is planned and managed on target.
• Collaborate and steer publication/communication plans with the respective functions to support successful go to market strategies
• To liaise with regional medical departments, providing updates on global plans and provision of training as subject matter expert
• To ensure that all medical activities are compliant and provide review of all promotional materials to ensure they are compliant, fair and balanced
• Lead the protocol development of non-interventional studies except PASS in close collaboration with all stakeholders
• Provide expertise to the related CSRs of post approval studies as required
• Leads extensively in developing scientific and medical expertise in biosimilar communication and in assigned therapeutic area
• Leads and coordinates educational and communication programs for Biosimilars and therapy areas as assigned
• Maintains general scientific expertise, including up-to-date knowledge of relevant international guidelines and requirements for global biosimilar drug commercialisation including but not limited to attendance of selected conferences.
• Leads the establishment of Advisory Board(s) to expand the understanding of the broad clinical and scientific community needs, prepares and attends meetings, attends debriefing of meetings and related follow-up activities
• Develops global medical plans that are fully aligned with commercial partners and integrated into global brand plans. Global medical plans to include publications, RWE, KOL engagement and data dissemination
• Provide high quality internal medical training on the biosimilar pathway, therapeutic area and biosimilar candidate core data
• Provides cross-functional input into biosimilar programs representing external KOL, HCP stakeholder views and needs.
• Contributes to the target product profile and positioning of the products
• Provides input and/or leadership to medical inquires as needed and assigned
• Materials signoff and maintain fair balance of communication and/with legal support

Skills and Requirements:

• Scientist or Medical Doctor with strong immunology background
• Fluent in English (verbally and in writing)
• 10+ years' experience within pharma with 5+ years' experience in Medical Affairs as a minimum in a large country, preferably in a regional or global role; further experience gained in Development (Ph I to IV) would be an asset
• Experience in biosimilars both in terms of development and launching would be an advantage
• Experience in Biotech product development pharmaceutical (or preferably Biotech) product development and launching at international level with extensive experience working directly with scientific communities and regulatory agencies
• Excellent presentation skills
• Ability to develop medical affairs plans along with proven experience in implementing e.g. successful real-world evidence generation, publication production, ad boards, KOL engagement, medical booths and symposia
• Strong knowledge of compliance requirements
• Ability to translate research language into customer understanding
• Ability to work in a matrix environment
• Excellent initiative and driven by the sense of urgency
• Strong communication skills
• Project management capabilities
• Entrepreneurial spirit and action/results driven
• Structured planning and execution

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Russell on +44 203 8246 104 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.