Medical Director UK & Ireland

Medical Director UK & Ireland

Roles and Responsibilities

• Lead Medical Affairs activities in the assigned indication
• 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

• Excellent English and native local language speaker

• Travel

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

• Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

• Equal Opportunity Employer/Veterans/Disabled

• An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

• Ireland Safety Responsibility

• Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

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