Description

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

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. Come join our team and make a meaningful impact on patients’ lives. 

• 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
• Provides subject matter expertise as well as leadership in key internal medical and clinical teams, called SMART teams, where s/he ensures that all critical components of medical plans are executed and monitored.
• 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

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

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

• Leadership of Integrated Evidence Teams

• Lead for development of the integrated evidence package for the therapeutic area

• 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

• Responsible for providing medical input into development, execution and interpretation of clinical protocols, including review of draft independent 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 in 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.

• Input into Scientific Communications strategy and guide Medical Communications with relevant stakeholders
• Contribute to the development of, review and approval of relevant global publication plans

• Support early disease training across the company. In collaboration with the Medical Affairs learning and development department develop content and modules for internal training

• Ensure compliance with policies, SOPs, Code of Business Conduct and Corporate Social Responsibility, as well as relevant legislation and regulations

• MD, PhD, PharmD or other advanced life sciences degree required. Current Medical Registration/Revalidation desirable, but not required.
• Extensive industry experience, especially in Medical Affairs (≥ 7 years) and Clinical Development, ideally in global roles
• Experience in Growth-related conditions desirable, either in pharmaceutical/clinical research or a clinical environment. Experience in Genetic Medicine is a plus. 
• Prior experience in specific disease area or Rare Diseases in pre-launch planning preferable

• 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 types of study phases 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.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.