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Program Medical Director, Hemophilia- Global Medical Affairs

Location Germany
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

Summary Description:

The Program Medical Director is a central strategic and executional role in the Global Medical Affairs (GMAF) function, leading Global and Regional Medical Affairs activities for BioMarin’s investigational hemophilia gene therapy BMN270 (valoctocogene roxaparvovec) through current pre-approval to post approval status. Reporting into the Program Global Medical Lead (GML), key product responsibilities include cross functional leadership, strategic alignment with commercial business partners, Medical Plan development, product launch strategy and execution, scientific message development and product scientific materials review, KOL relationship management and medical monitoring of post-approval commitments.

Key Responsibilities:

Provide GMAF Leadership for BioMarin’s investigational hemophilia gene therapy product, BMN270 (valoctocogene roxaparvovec):

Global Program Strategy & Execution

The Program Medical Director will support the Program Global Medical Lead (GML) with the planning, communication and execution of the Global Medical Strategy and related tactics, in alignment with the overall Brand Plan and Program Drivers, with following responsibilities:

  • A central member of the BMN270 Global Medical Affairs Program team (Matrix Team), assisting in the development, communication and execution of the Global Medical Plan in collaboration with Medical Affairs stakeholders across BioMarin
  • Medical-scientific product and disease area expert, partner and central contact point for compound or disease area related issues both for GMAF and partner teams
  • Identify, develop and maintain the scientific messaging platform with Medical Communications and help coordinate input from relevant cross-functional stakeholders
  • Undertake critical appraisal of available scientific and medical information, identify gaps and drive activities to address deficiencies
  • Review and approve product materials, including product educational materials, information resources, study documentation, regulatory dossiers, internal briefing material, medical information response documents, slide decks, etc.
  • Enable scientific messaging and gap analysis regarding product or disease area
  • Contribute to the development of, and review and approve the Program Publication Plans
  • Medical Affairs contributor to data generation strategy and planning, including Clinical Development, Life Cycle Management, Data Evidence and Integration

Cross Functional GMAF Engagement:

  • Represent GMAF and enable cross-functional engagements, providing input for relevant partner teams, e.g. Global Launch, Brand Planning, Business Unit Directors, Market Access, Patient Engagement and Advocacy, Communication and External Engagement, Clinical Development team

Product Launch

  • Key contributor to the development of the Medical Affairs global product launch strategy and roadmap and lead all Medical Affairs global launch activities in collaboration with Commercial and other key stakeholders

Market relationship and access development

  • Coordinate the GMAF Stakeholder Engagement Plan including insights generation and communication with global and regional thought leaders, and uphold appropriate engagement and access to KOLs during entire product lifecycle
  • Help structure the external medical education program to reach stakeholders at all levels in preparation for and utilization of the product and related components
  • Provide medical leadership for international symposia, advisory boards and round table meetings and contribute GMAF strategical input to similar regional initiatives

Filing / Regulatory Authority (RA) interaction

  • Assist in writing and labelling initiatives that encompass the disease state, medical need, natural history and risk/benefit sections of BLA and MAA and other Regulatory submissions
  • Represent Medical Affairs at FDA/EMA and other RA advisory board meetings

Post Marketing – Registries, IR, observational

  • Provide medical monitor support into the development, design and execution of post approval studies falling under GMAF scope in coordination with Medical Affairs Study Management and in accordance with respected regulatory requirements
  • Assist in critically evaluating pipeline and post-authorization studies’ results in statistical and final reports and ongoing reviews with study investigators, resolving problems arising in the course of clinical investigations and preparing reports to the management and medical community
  • In collaboration with Regional Medical Product leadership and Area/Country Medical Leads, conduct critical scientific and medical review of IR protocols

Internal Learning and Development

  • Support internal L&D strategy and related training deliverables, including preparing and coordinating GMAF briefings, guidance, Q&A’s and topical talking points and med-ed modules
  • Assist in the training of new recruits in the cross-functional organization by presenting the scientific disease and product related data and present at conferences, regional meetings, etc. to develop high level of medical knowledge within sales force

Education and Experience:

  • Medical degree preferred
  • 5 or more years of relevant regional level Medical Affairs experience; global experience preferred

Work Environment:

The employee will be required to undertake local and international travel 40-50% of their time (post Covid19 current working restrictions), which will periodically include weekends



We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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Germany

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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