Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research and Development

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.

• 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 Country Medical Leads, RWE/Epidemiology, and HEOR to understand key global and local (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 appropriate
• 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
• 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
• Designs secondary data analysis plans of BioMarin clinical and real-world data to support program strategy
• 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
• Presents 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.

• 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.

• PharmD/PhD/MD with 5+ years clinical and/or medical affairs experience conducting observational and Phase IIIb/IV studies within the biopharmaceutical industryor, MS/MPH with 10+ years similar experience
• Has 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 objectives
• Experience responding to regulatory agency, IRB/Ethics Committee questions regarding study designs and protocol conduct

• Subject matter expertise in a global competitive environment for executing medical affairs programs/studies; rare disease experience desirable
• Novel prospective observational and interventional study designs
• Understanding of statistical and data analysis, research methods and design
• Study 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

• 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.

• The 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

Candidate Profile

 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.