Medical Scientific Director
About this opportunity
<p><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Who We Are </span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.</span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.</span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. </span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">About Worldwide Research and Development </span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">From research and discovery to post-market clinical development, our R&D 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 rare diseases.</span></p><p style="text-align: center;"><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;"><b>Medical Scientific Director (Associate Director)</b></span></p><p style="text-align: center;"><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;"><b>London (Hybrid role)</b></span></p><p style="text-align: center;"></p><p><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">The Medical Scientific Director <span style="color: black;">is accountable for </span>the day-to-day oversight of numerous BioMarin-sponsored and collaborative studies <span style="color: black;">across a therapeutic area,</span> <span style="color: black;background: white;">ensuring consistency of approach, conduct, monitoring, analysis, and reporting of studies within one or more programs</span>.<span style="background: white;"> The </span>Medical Scientific Director<span style="background: white;"> 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.</span></span></p><p><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">The Medical Scientific Director is part of the Integrated Evidence function comprised of subject matter experts in evidence planning, observational 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 medical practice on appropriate use and long-term safety and effectiveness of BioMarin products to drive clinical adoption.</span></p><p><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;"><b>Key Responsibilities</b></span></p><p><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;"><i><u>Study Strategy and Implementation </u></i></span></p><ul><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Executes evidence generation activities (non-interventional, low-interventional and interventional Phase IIIb/IV studies) that will fill priority evidence gaps identified in product Integrated Evidence Plans (IEPs)</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Collaborates closely and builds alliances with Global and Country Medical Leads, RWE Lead, and HEOR to understand key global and local (key market) needs and opportunities in order to develop strategic study pull through and dissemination plans</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Collaborates closely with operational strategic partners to ensure successful implementation of GMAF-led studies; identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Provides 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 protocols</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Leads 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 addressed</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Designs secondary data analysis plans of BioMarin clinical and real-world data to support program strategy</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Ensures 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 activities</span></li><li><span style="color: black;">Presents results of assigned studies to internal and external stakeholders, including at scientific conferences, and other relevant forums.</span></li><li><span style="color: black;">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.</span></li><li><span style="color: black;">Participates in initiatives to enhance or drive efficiency in study implementation</span></li></ul><p><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;"><b>Desired Experience</b></span></p><ul><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">PharmD/PhD/MD with at least 5 years </span><span style="color: black;">experience conducting </span><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">observational and Phase IIIb/IV </span><span style="color: black;">studies within Clinical Development and/or Medical Affairs; </span><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;"> </span><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">MS/MPH with 10+ years similar experience</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">E</span><span style="color: black;">xperience in delivering a portfolio of </span><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">protocols and ensuring they meet strategic program objective</span></li><li><span style="color: black;">Experience responding to regulatory agency, IRB/Ethics Committee questions regarding study designs and protocol conduct</span></li></ul><p><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;"><b>Skills</b></span></p><ul><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Proven track record of working with cross-functional partners to ensure successful end-to-end delivery of studies in support of product Integrated Evidence Plans.</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Track record of delivering high quality novel observational and Phase IIIb/IV studies</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Works effectively in a cross-functional matrix settings to shape the study strategy for one or more assigned projects</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Awareness of novel prospective observational and interventional study designs</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Understanding of statistical and data analysis, research methods and design</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Experience in study monitoring</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Advanced knowledge of the clinical research process and Good Clinical /Pharmacoepidemiology Practice standards and requirements relating to conducting research and disseminating of scientific information.</span></li><li><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Strong scientific writing and document development</span></li></ul><p><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">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. </span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">Equal Opportunity Employer/Veterans/Disabled </span><br /><br /><span style="font-family: sans-serif , arial , helvetica;font-size: 11.0pt;">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.</span></p>
Job details
How this role compares
Computed from every other active Other / Corporate Functions role in our database, not just this employer's listings.
We don't have enough classified peer data for this role yet, so there's no comparison to show. This happens when a posting's title/category doesn't match any taxonomy rule -- it's excluded rather than compared against the wrong peer group.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.