Job purpose:

The Associate Director, Medical Affairs is responsible for leading all medical strategy and activities for the Biogen Alzheimer’s Disease (AD) portfolio

 Accountabilities:

Strategic leadership

Provide affiliate medical input into regional / global medical strategy for AD, leveraging local customer insights that help prepare the anticipated introduction of new medicines, working cross-functionally with key internal partner functions, to address the medical and scientific needs of the UK affiliate    

• Lead, develop and implement country AD medical plans, partnering with the affiliate leadership team across functions to define, establish and execute a coherent local strategic plan that addresses patient needs
• Lead and partner with the AD field medical lead to ensure full alignment with global/regional medical strategy and support initiatives to better understand and support clinical needs and challenges for early AD 
• Partner and collaborate with market access to demonstrate medical value of approved products and compounds in development, relevant to local external stakeholders (payers, HCPs, agencies)
• Plan and execute Phase IV studies, Registries, IITs and SRAs for AD as required
• Collaborate closely with cross functional colleagues including commercial teams, to create and drive medical tactics that have the potential to enhance patient outcomes and well-being, that deliver value to both patients and their healthcare teams
• Support regulatory strategies for product specific activities
• Provide medical affairs strategic input and support for late stage development/near launch AD therapies
• Collaborate with Global Clinical Operations and Clinical Country Lead (CCL) on early phase trials in the AD pipeline, Phase III and Phase IV activities (including site and PI lead selection) and support IITs & SRAs where appropriate
• Collaborate with Government & Corporate Affairs teams to develop and implement a communication strategy
• Develop and manage budgets for medical activities and provide input into the affiliate budgeting and planning process
• Build local medical science expertise of the Biogen Alzheimer’s portfolio
• Facilitate sharing of best practices and knowledge across products and locations (internal training)
• Support regulatory strategies for product specific activities
• Facilitate activities around the Medical Information request process, patient support programme (via patient services and support - PSS) and patient
   

Line management

Provide line management of the MSL lead and office-based AD staff
 

External Liaison

• Develop and manage an external key medical expert (KME) network to ensure relevant and appropriate engagement and collection of disease area and therapeutic insights to inform on medical strategy and tactical execution
• Oversee the development of high value-added and informative continuous medical education programmes in AD for external stakeholders
• Coordinate medical review of country-specific AD materials to ensure scientific accuracy and ensure material approval (certification) meets all internal and external polices and standards (eg: ABPI Code of Practice)
• Coordinate medical review and approval, where appropriate, of specific materials that relate to cross-border engagements and congresses (eg: Biogen Standalone meetings and Satellite Symposia) where Biogen-sponsored UK HCPs/KMEs attend and will be exposed to company product data

Internal liaison/Team management

• Build, support and develop a world class medical team for AD in UK & Ireland, providing direction, developing scientific relationships based on credibility, respect & trust with other internal functions and external organisations and industry peers
• Provide leadership and oversight of all aspects of medical affairs relating to AD, including all medical operations, patient services, medical information and pharmacovigilance activities, working both directly (with direct reports) and indirectly through matrix connections across the affiliate business
• Provide medical perspective and knowledge to other teams within the affiliate and at regional/global level
• Identify lifecycle extension opportunities for product based on patient needs
• Create a climate in which self-motivated individuals will aspire to higher levels of performance

Ensure exchange of medical information with other functions as appropriate, for medical affairs and behave as a role model

Competencies required for the role:
Technical’ Competencies

• Strategic acumen: Excellent understanding of strategic and business needs of the affiliate organisation
• Scientific acumen: Hold ‘peer to peer’ relationships with top tier AD thought leaders
• Statistical & data interpretation: Required for review and support of medical information and educational/promotional materials
• Medical writing as required
• Experience in reviewing and approving promotional and non-promotional materials, and in-depth knowledge and understanding of the ABPI UK Code of Practice
• ABPI Final Medical Signatory
   

Process Related Core Competencies

• Focus on scientific exchange: interactions with KMEs, physicians and patient organisations and internal stakeholders
• Communicating effectively: Ability to convey complex scientific concepts and information appropriately tailored to respective audiences e.g. affiliate staff, regional/global Medical Affairs leadership and external stakeholders
• Relating skills: Strong requirement to build and maintain relationships with internal and external stakeholders
• Process management: Strong project management, people management and success measurement skills

Qualifications required for the role:

• Min 5+ years’ experience within a medical affairs role in
• Pharmaceutical industry (prior experience in Neurology, Immunology/Dermatology and/or Hematology preferred)
• Diploma in pharmaceutical medicine and active involvement in PMST preferred
• Knowledge and understanding of disease area, local health care system/market dynamics, regulations, policies and SOPs, health economic techniques and trends
• Broad experience in interaction with health authorities
• Demonstrated strategic approach to effective implementation of scientific communication programs on disease areas and treatments
• Demonstrated leadership skills and acquired knowledge and skills/competencies to the degree expected at job level

Education required: 

• MD, PhD (or equivalent) degree is essential
• Diploma in pharmaceutical medicine or equivalent preferred