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The Global Medical Lead, Director level, is a critical leadership role in Global Medical Affairs, working on global activities for BioMarin's Enzyme Conditions portfolio. The role reports into the Global The Medical Lead – ENPP1 Deficiency & LSD and represents Medical Affairs in core cross-functional teams.
Job Responsibility:
In partnership with the Commercial organization, co-develops the Integrated Brand Plan (IBP), as core member of the 3M (Medical – Marketing – Market Access) Team
Offers scientific and medical expertise to inform the overall product strategy, contributing to clinical development, commercialization, and market access plans
Leads development, execution, and communication of the Global Medical Plan in collaboration with other internal stakeholders across BioMarin
Provides subject matter expertise as well as strategic leadership in key internal medical and clinical teams
Act as product and disease area expert and primary contact point for all global compound or disease area related issues both internally and for the external community
Partner with other departments, such as commercial, finance, and clinical development, to ensure that the medical affairs budget supports and aligns with overall business goals
Develop Medical Affairs launch strategy and roadmap and lead all Medical Affairs launch activities in collaboration with Commercial and other key stakeholders
Represent Medical Affairs in the development of regulatory documents and submissions
Represent Medical Affairs at FDA/EMA meetings
As a core member of the Integrated Evidence Team, contributes to the development of the integrated evidence package for therapeutic area
Ensure tactics led by Medical Affairs are included in the Medical Plan and delivered in a timely manner
Responsible for providing medical input into development, execution and interpretation of Clinical Development Plans, clinical protocols, including review of draft external research protocols, reports and manuscripts
Contribute scientific expertise to development of real-world evidence projects including, disease registries and post-marketing commitments
Evaluation of safety issues associated with product in collaboration with other departments
Assistance in critically evaluating study results for statistical and final reports and ongoing reviews with study investigators, resolving problems arising during clinical investigations and preparing reports to management and medical community
Guide development of the Medical Engagement strategy with the Medical Engagement Lead ensuring inclusion of key stakeholders, tools are developed to support execution, and mechanisms are in place to measure impact
Set the aspirational scientific narrative for therapeutic area and contribute to the development of, review and approval of relevant global publication plans
Contribute scientific expertise to the development of Implementation Science projects as part of Health Systems Engagement
Support internal disease and product training in collaboration with Medical Affairs Learning and Development
Ensure compliance with policies, SOPs, Code of Business Conduct and Corporate Social Responsibility, as well as relevant legislation and regulations
Requirements:
MD, PhD, PharmD or other advanced life sciences degree required
Extensive industry experience, especially in Medical Affairs (≥ 7 years) and Clinical Development, ideally in global role with experience in Genetic Medicine or LSDs/Rare Disease inherited metabolic conditions
Ability to work, influence, and gain consensus across regions and cross-functional teams
Demonstrate solid understanding of cross-functional inter-dependencies across the drug development lifecycle
Excellent communication skills and a strong enterprise mindset required for problem solving and high-level presentations for senior executive staff review
US and international experience working in orphan or specialty markets
Knowledge and hands-on skills required to develop the strategy, framework, and scientific content for a wide range of post marketing studies
Knowledgeable and current in GCP guidelines and compliance rules globally
Clinical trial and publication experience is desirable
Track record of successfully influencing without authority, partnering across functions especially with but not limited to Commercial
Ability to understand the organization's financial goals, market landscape, and strategic objectives, and to apply that understanding to support scientific and strategic initiatives that deliver value to both patients and the company
Able to thrive in an ambiguous and demanding environment, with high capacity for effective relationship building and teamwork