Medical Director UK & Ireland

Medical Director UK and Ireland  

Roles and Responsibilities:  

• Lead Medical Affairs activities in the assigned indications  

• Define and implement the medical strategy according to the company's orientations, and for the entire product portfolio developed by BioMarin 

• Oversee and lead the Medical Affairs activities in the UK & Ireland  

• Coordinate Medical Affairs activities to ensure the successful implementation of Action Plans and support BioMarin clinical development activities. 

• Develop and deliver scientific and medical information to answer specific and documented questions from Healthcare Professionals (HCPs).  

• Lead the Medical Affairs team developing and maintaining the expertise of all members of the Medical Affairs Team for the therapeutic areas covered BioMarin 

• Contribute to the development of knowledge of the relevant products and pathologies, externally and internally.  

• Ensure compliance of Medical Affairs activities to BioMarin policies and procedures, as well as all local regulatory and legal requirements. Ensure that appropriate systems and SOP/processes are being followed to meet these requirements.  

• Interact and optimise relationships with Thought Leaders and other members of the medical community to assist in understanding current disease management issues and data gaps in BioMarin areas of interest  

• Encourage appropriate research collaborations with academic institutions in predefined Areas of Research Interests.  

• Participate as an active and integral member of the region management team  

Medical strategy:  

• Define, develop, oversee, and effectively implement the country medical strategies for products already marketed and for investigational agents in development.  

• Represent country interests to the Global and International medical teams to guide the long term strategy of the product portfolio.  

• Be the preferred scientific and medical contact with external thought leaders, Patient Associations and National Regulatory authorities;  

• Provide advice and scientific assistance to General Manager and other functions of BioMarin  

• Under the supervision of the General Manager, and in collaboration with the Market Access department and regulatory affairs contribute to the development of National Reimbursement applications.  

• Partner effectively with Country Medical Directors in the EUCAN region to contribute to overall International and Global Medical Strategy  

Clinical research:  

• Define and implement, in conjunction with health authorities, risk management plans, Phase IV studies and cohort follow-up studies for registered products while ensuring compliance with the Company's ethics and interests.  

• Contribute to the development of public-private partnerships or research partnerships, including coordinating the implementation of studies led by an external investigator (Investigator Initiated Studies).  

Medical affairs:  

• Participate in scientific events, national or international congresses, meetings organized by learned societies or foundations.  

• Ensure compliance with country regulations for all oral and written scientific communications on products and their environment;  

• Develop scientific projects, patient support programs, medical education programs and clinical studies in collaboration with experts in the diseases covered by BioMarin gathered within Advisory Boards  

• Respond promptly to requests for scientific and medical training;  

• Where appropriate, write the medical part of the files for Regulatory Authorities, or any other Health Authority  

Medical governance:  

• Contribute to the drafting and implementation of procedures that govern the activities of the Medical Team;  

• Comply with, and enforce, regulatory obligations;  

• Comply with, and enforce, BioMarin regulatory obligations and procedures or scientific and medical information in response to HCP requests.  

Educational Requirements  

• Higher Degree (MD/PhD) with a Medical Doctorate preferred, or UK Pharmacist  

Professional Work Experience Requirements  

• Substantial experience with a leading international life science company within the biopharmaceutical/pharmaceutical industry  

• Track record of success as Medical Manager or Director, acquired in the field of Medical Affairs  

• Material review experience as ABPI Final Signatory  

• Scientific and medical expertise in rare diseases, personalized medicine and innovative products. Prior expertise in Lysosomal Disorders and or Rare Disease is a plus  

• Demonstrated initiative and an ability to build a market for a new therapy  

• Strong understanding of the respective country’s Health Care system including health technology assessment, regulatory processes and pharmacovigilance requirements  

• Thorough experience and confidence when positioning biologic products with selected Thought leaders and prescribing physicians and hospitals  

• Experience in communicating and building relations with authorities, health care sector professionals including specialist care and sales, as well as Thought Leader management  

• Strong track record in in delivering well defined and measurable results (plan vs. actual)  

• Experience in organizing scientific events and/or managing external experts KOLs management  

• Knowledge of research and clinical development 

Experience and Skills  

• Strong demonstration of, and role model for BioMarin culture  

• Strategic vision and ability to simultaneously execute multiple projects involving rapid decision making  

• Good organization and adaptability  

• Strong interpersonal skills  

• Team player  

• Takes responsibility  

• Projects confidence and integrity  

• Works well in ambiguous and challenging environments  

• Respectful of cultural differences  

• Strategic outlook with tactical capability  

• A passion for helping patients with rare diseases  

• Great scientific rigor  

Other skills/Attributes  

• Demonstrated alignment with BioMarin values (BioMarin)  

• Passion for rare disease and patient focused  

• Excellent English and native local language speaker  

Travel  

• Domestic and occasional International travel required (20 - 40%)