Program Medical Director, Hemophilia- Global Medical Affairs
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.
The Program Medical Director is an important strategic and executional role in the Global Medical Affairs (GMAF) function, in relation to Global 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 partnership, 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.
Contribute to the medical 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 Strategic Medical Affairs team (SMART), 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 for compound or disease area related issues both for GMAF and partner teams.
- 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.
- Drive scientific messaging and gap analysis in partnership with SMART colleagues regarding product and/or disease area
- Contribute to the development and review of the Program Publication Plans
- Contributor to data generation strategy and planning, including Clinical Development, Life Cycle Management, Data Evidence and Integration
Cross Functional GMAF Engagement:
- In association with GML, 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
- 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
- Together with the GML, 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
- Provide strategic direction and medical input for 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 Globally-led 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
- If needed, to represent Medical Affairs at regulatory team discussions.
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 Data Evidence & Integration teams 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 only
- 5 or more years of relevant regional level Medical Affairs experience; global experience preferred
The employee may be required to undertake local and international travel 30% of their time , which will periodically include weekendsWe 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.