Global Medical Lead, Executive Director - Hemophilia
San Rafael, CA
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\u00A0is 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.\u00A0\u00A0Key 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.\u00A0 \u00A0Disease 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 \u00A0Cross Functional LeadershipAct as the Medical Affairs representative on key cross-functional product and development strategic focused teamsRepresent Medical Affairs on relevant commercial teams: Launch Team, and Global and/or Regional Brand Teams for product\u00A0Market\u00A0Relationship and Access DevelopmentManage contact with top medical experts, ensuring high level r scientific exchange and leadershipProvide oversight for regional and/or international symposia, advisory boards, manuscripts\u00A0Launch ExcellenceDevelop Medical Affairs launch strategy and roadmap and lead all Medical Affairs launch activities in collaboration with Commercial and other key stakeholdersFiling / RegulatoryRepresent Medical Affairs at FDA/EMA advisory board meetingsRepresent Medical Affairs in label discussions \u00A0Integrated Evidence PackageLead for development of the integrated evidence packageMay act as medical monitor for PMR/PMC and studies falling under the Medical Affairs scope in collaboration with Medical Affairs Study managementOversee clinical registriesAssist 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 communityIn collaboration with Regional Medical leadership and Area Medical Leads, conduct critical scientific and medical review of IR protocols and local studies\u00A0TrainingSupport early disease training across the company. In collaboration with the Medical Affairs learning and development department develop content and modules for internal trainingThe\u00A0Medical lead\u00A0is 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. \u00A0Desired SkillsBe recognized as a highly capable leader with enterprise skills and external leadershipActively foster disease area strategy working relationships with key influential stakeholders inside and outside of BioMarinDemonstrate deep medical and scientific knowledge in HemophiliaDemonstrate solid understanding of cross-functional inter-dependencies across the drug development lifecycleHave ability to design studies, develop protocols and monitor studies in a wide range of types of study phases pre and post marketing\u00A0\u00A0Education and ExperienceMD, PhD, PharmD or other advanced life sciences degree required5 or more years of relevant experience in global medical affairs and/or clinical development, desire2 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.
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