Medical Scientific Director (Associate Director) - US (also open in UK)
San Rafael, CA
Medical Scientific Director (Associate Director)\u00A0\u00A0\u00A0The Role\u00A0The Medical Scientific Director, reporting into the Lead, Medical Scientific Director Team, is a newly created role that is accountable for the day-to-day oversight of numerous BioMarin-sponsored and collaborative studies across a\u00A0therapeutic area, ensuring consistency of approach, conduct, monitoring, analysis, and reporting of studies within one or more programs. The Medical Scientific Director will work in partnership with Real World Evidence (RWE)/Epidemiology, Global Medical Leads, Data Sciences and Global Study Operations to develop practical study strategies and ensure optimal hands-on study operations and execution support for Medical Affairs-led studies from cross functional partners. \u00A0The Medical Scientific Directors are part of the Evidence Planning and Strategy Function comprised of subject matter experts in evidence planning, study design and data interpretation. The function works to drive excellence in evidence planning and implement novel study design approaches to generate robust evidence to enhance understanding of unmet medical need; support patient and endpoint selection for Clinical studies; and inform clinical practice on appropriate use and long term safety and effectiveness of Biomarin products. \u00A0\u00A0Key Responsibilities \u00A0Study Strategy and Implementation Designs and executes evidence generation activities (non-interventional, pragmatic, low-interventional and interventional Phase IIIb/IV studies) that will fill priority evidence gaps identified in product Integrated Evidence Plans (IEPs)Collaborates closely and builds alliances with Global and Regional Medical Leads, RWE/Epidemiology, and HEOR to understand key global and regional (key market) needs and opportunities in order to develop strategic study plans Collaborates closely with operational strategic partner involvement to ensure successful implementation of GMAF-led studies; identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriateProvides scientific input into the development of study concepts, protocols and protocol amendments, statistical analysis plans, data review plans, and responses to regulatory agency questions regarding scientific aspects of study protocolsLeads the development of annual, interim and periodic study reports for Medical Affairs-led studies, including coordination of SME input, data interpretation and presentation, and ensuring that regulatory agency questions (where relevant) have been adequately addressedDesigns secondary data analysis plans of BioMarin clinical and real world data to support program strategyEnsures adequate medical monitoring oversight of assigned studies (where relevant) including monitoring and arbitration on subject eligibility, quality of safety and study data, development and review of ICFs, CRFs, TLGs, accurate AE and concomitant medication coding, and inspection readiness activitiesPresents results of assigned studies to internal and external stakeholders, including at scientific conferences, and other relevant forums.Participates in program program-wide Medical Affairs and cross-functional asset teams; contributes to discussions to ensure consistency across assigned studies.\u00A0Quality, Compliance and Process improvement Participates process enhancements and solutions for complex issues including implementation of controlled documents for protocol and study report development, study monitoring plans Coordinates Medical Affairs input in preparation of regulatory submissions, responses to regulatory queries, IRB/Ethics Committee questions, and in preparation for program regulatory inspections and audits for assigned programs.\u00A0\u00A0\u00A0\u00A0Desired Experience \u00A0BA/BS or Master\u2019s level degree in life sciences or health related field with 10 years experience with increasing responsibilities, complexity and accountabilities or, PharmD/PhD/MD 5 years Minimum 5 years clinical and/or medical affairs experience conducting observational and Phase IIIb/IV studies within the biopharmaceutical industryHas independently authored protocol concept documents, study protocols, plans, data review, review/development of statistical analysis plans and outputs, and study reports Experience in translating strategic evidence plans into scientific concepts in multiple protocols and ensuring they meet strategic program objectivesExperience responding to regulatory agency, IRB/Ethics Committee questions regarding study designs and protocol conduct\u00A0\u00A0Technical competencies\u00A0Subject matter expertise in a global competitive environment for executing medical affairs programs/studies; rare disease experience desirable Novel prospective observational and interventional study designsUnderstanding of statistical and data analysis, research methods and designStudy monitoring Advanced knowledge of the clinical research process and Good Clinical/Pharmacoepidemiology Practice standards and requirements relating to conducting research and disseminating of scientific information.Scientific writing and document development\u00A0In terms of the performance and personal competencies required for the position, we would highlight the following:\u00A0Collaboration Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in his/her beliefs, and active drive.Creates a sense of purpose/meaning for the team that generates followership beyond his/her own personality and engages others to the greater purpose for the organization as a whole.\u00A0\u00A0Executing for ResultsThe ability to set clear and challenging goals while committing the organization to improved performance, tenacious and accountable in driving results.Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.A leader who is viewed by others as having a high degree of integrity and forethought in his/her approach to making decisions; the ability to act in a transparent and consistent manner while always taking into account what is best for the organization\u00A0This role can be based in the US or EuropeCandidate ProfileBioMarin is looking for an experienced Scientific leader with a proven track record of working with cross-functional partners to ensure successful end-to-end delivery of GMAF-led studies in support of product Integrated Evidence Plans. This person has ideally had experience in both Clinical Development and Medical Affairs in the peri and post launch setting and a track record of delivering high quality novel observational and Phase IIIb/IV studies. This candidate will work in cross-functional matrix settings to shape the study strategy for one or more assigned projects, thereby a collaborative mindset is required. \u00A0\u00A0\u00A0
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