UK Associate Director Medical Affairs, Rare Diseases

Proclinical is working with a multinational biopharmaceutical company with approximately 2,500 dedicated employees serving patients in more than 50 countries through the innovation, development, and commercialization of life-changing therapies. This company is seeking an Associate Director Medical Affairs, to be based in London on a permanent basis.

Reporting to the Senior Medical Director, UK and Ireland, The Associate Director, Medical Affairs will provide scientific and medical leadership and support to all functions within the affiliate to ensure achievement of local objectives and to further the company Global Medical Affairs mission to maximize patient outcomes by setting and continuously advancing the evidence-based medical standard of care.

Job Responsibilities:

• Develop and continuously maintain the highest scientific and medical expertise with all diseases and products and be acknowledged internally and externally as an expert in these areas
• Develop and implement a local Medical Affairs Plan and strategy, to support best clinical practice and the overall corporate objectives
• Actively engage with EMEA and Global Medical Affairs and other functions to ensure the effective local implementation of company strategy and appropriate use of local market intelligence and development opportunities
• Maintain a high level of knowledge of and appropriately implement UK and Ireland pharmaceutical regulations and company policies and procedures in conjunction with Pharmaceutical Affairs
• Build relationships with thought leaders within Metabolic Medicine, other healthcare professionals and stakeholders, including patient groups and professional organisations.
• Provide medical leadership, insight and strategy to all company activities, collaborating across functions, including ensuring the highest level of medical education for all company employees to maximize patient outcomes
• Identify and implement appropriate high-impact medical research projects to support the business objectives, including company -sponsored and investigator-initiated projects
• Manage requests for company product supply in off-label and compassionate use cases, in accordance with local and company procedures
• Provide support for the development, review and approval of presentation materials for scientific meetings, symposia and other Medical Education activities (external).
• Act as Deputy Drug Safety Officer, in conjunction with EMEA and Global Pharmacovigilance, to ensure pharmacovigilance requirements are fulfilled according to regulatory and company policy
• Lead the implementation of medical affairs practices to assess new indications, the treating community, patient pathways, identifying patients for clinical research

Skills and Requirements:

• Medical degree or advanced degree, preferably in the health care sciences
• Relevant and significant experience in the pharmaceutical or the biotech industry (or experience with biological product)
• Background / experience in metabolic diseases, paediatrics or genetic diseases preferred
• Orphan diseases knowledge/experience preferred
• Eligible for or already registered for PMST; Membership of the Faculty of Pharmaceutical Medicine preferred
• Good analytical skills as applied to medical, scientific and technical information
• Excellent knowledge of local and/or regional regulations and requirements for Pharmacovigilance with strong knowledge of local pharmaceutical regulations and related ethic behaviours relating to regulatory, quality and PV activities
• Strong knowledge of regulatory inspections with the ability to effectively handle all situations that may occur and determine appropriate strategies and courses of action
• Demonstrated ability to accurately and effectively evaluate medical/scientific literature and develop effective medical strategies and communication strategies
• Excellent written and verbal communication skills; second language an advantage
• Strong project management, interpersonal, communication and presentation skills
• Adaptability to multicultural environment.
• Strong team player but able to work independently
• Identify priorities and manage deliverables
• Exhibits strong leadership ability
• Excellent problem solving, organizational, and negotiating skills
• Exhibits composure under pressure
• Sense of ethics and responsibility
• Medical degree and higher medical qualification such as MRCP or MFPM an advantage
• Bachelor of Science or Pharmacy degree at upper second-class honours level or above with higher degree such as PhD or PharmD

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.