Who We Are

From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases.

The Global Medical lead is a critical leadership role in Global Medical Affairs, working on global and/or regional Medical Affairs activities for BioMarin's gene therapy product for hemophilia A. Key responsibilities include, but are not limited to, cross functional leadership, strategic alignment with commercial business partners, Medical Plan development, launch strategy and execution, scientific leadership, and external medical expert engagement. This leader will also be critical in leading Medical Affairs studies in the therapeutic area. This leader reports directly to the Head of Global Medical Affairs and is a core member of the Global Medical Affairs leadership team. This leader also leads the Hemophilia global medical team, represents Medical Affairs in all core strategic teams in Development and Commercial.

Disease Area Strategy & Execution

• As a global medical lead, you will lead development, execution, and communication of the Global Medical Plan in collaboration with other internal stakeholders across BioMarin
• Act as product and disease area expert and primary contact point for all global compound or disease area related issues with the external community and internal at BioMarin
• Lead scientific leadership and guide Medical Communications and other relevant stakeholders
• Conduct critical appraisals of available scientific and medical knowledge, identify gaps, and lead activities
• Contribute to the development of, review and approve global publication plan
• Lead Integrated evidence plan strategy and execution of hemophilia disease area
  

Cross Functional Leadership

• Act as the Medical Affairs representative on key cross-functional product and development strategic focused teams
• Represent Medical Affairs on relevant commercial teams: Launch Team, and Global and/or Regional Brand Teams for product

Market Relationship and Access Development

• Manage contact with top medical experts, ensuring high level r scientific exchange and leadership
• Provide oversight for regional and/or international symposia, advisory boards, manuscripts

Launch Excellence

• Develop Medical Affairs launch strategy and roadmap and lead all Medical Affairs launch activities in collaboration with Commercial and other key stakeholders

Filing / Regulatory

• Represent Medical Affairs at FDA/EMA advisory board meetings
• Represent Medical Affairs in label discussions

Integrated Evidence Package

• Lead for development of the integrated evidence package
• May act as medical monitor for PMR/PMC and studies falling under the Medical Affairs scope in collaboration with Medical Affairs Study management
• Oversee clinical registries
• Assist in critically evaluating study 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 company management and the medical community
• In collaboration with Regional Medical leadership and Area Medical Leads, conduct critical scientific and medical review of IR protocols and local studies

Training

• Support early disease training across the company. In collaboration with the Medical Affairs learning and development department develop content and modules for internal training
• The Medical lead is expected to exhibit mastery-level understanding of multiple competencies, including communication and medical and scientific knowledge as well advances skills in strategic thinking, problem solving, business acumen and drug development, regulatory and study design.

Desired Skills

• Be recognized as a highly capable leader with enterprise skills and external leadership
• Actively foster disease area strategy working relationships with key influential stakeholders inside and outside of BioMarin
• Demonstrate deep medical and scientific knowledge in Hemophilia
• Demonstrate solid understanding of cross-functional inter-dependencies across the drug development lifecycle
• Have ability to design studies, develop protocols and monitor studies in a wide range of types of study phases pre and post marketing

Education and Experience

• MD, PhD, PharmD or other advanced life sciences degree required
• 5 or more years of relevant experience in global medical affairs and/or clinical development, desire
• 2 or more years of industry experience in hemophilia or non-oncology hematology

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.

In the U.S., the salary range for this position is $ 280,000 to $ 420,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.