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The Global Medical Lead, Sr. Director level, is a critical leadership role in Global Medical Affairs, working on global activities for BioMarin's LSD portfolio. The role reports into the Global Medical Unit Head for PKU/LSDs and represents Medical Affairs in core cross-functional teams.
Job Responsibility:
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 leadership in key internal medical and clinical teams, called SMART teams, where s/he leads development of the medical plan and ensures that all critical components of medical plans are executed and monitored for the intended impact
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
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 development of regulatory documents and submissions (e.g. briefing books, protocols, label discussions etc.)
Represent Medical Affairs at FDA/EMA meetings
Leads the Integrated Evidence Team for development of the integrated evidence package for the therapeutic area. Ensures timely execution of the plan to ensure data gaps are filled optimizing patient access
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
Oversight of clinical registries and other 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 in the course of 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
Contribute to the development of, review and approval of relevant global publication plans. Ensure publications are appropriately shared with the external community to optimize patient care
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 roles
Experience in LSDs/inherited metabolic conditions is desirable, either in pharmaceutical/clinical research or a clinical environment
Experience in Genetic Medicine is a plus
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
Have ability to design studies, develop protocols and monitor studies in a wide range of study types and phases including pre and post marketing
Knowledgeable and current in GCP guidelines and compliance rules globally
Clinical trial and publication experience is desirable
Track record with successfully influencing without authority, partnering across functions especially with but not limited to commercial
Solid business acumen with high scientific inquisitiveness
Able to thrive in an ambiguous and demanding environment, with high capacity for effective relationship building and teamwork
Flexibility and adaptability
Sensitivity to a multicultural environment
Willingness to travel, mostly internationally
English proficiency required
Nice to have:
Experience in LSDs/inherited metabolic conditions is desirable
Experience in Genetic Medicine is a plus
Clinical trial and publication experience is desirable