**Remote or Hybrid in SRC (San Rafael Campus) & Opened in London**

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.

• Collaborate with key cross-functional stakeholders (e.g., clinical, medical, regulatory, advocacy, commercial, global study operations, data science) to:
• Lead PCOS data and evidence generation planning and execution to meet cross-functional stakeholder needs 
• Identify, select, and implement fit-for-purpose COA tools in the interventional and non-interventional studies to support regulatory approval, labeling claims, and commercial success
• Drive de novo COA tool development to fill evidentiary gaps
• Contribute as key subject matter expert (SME) for qualitative and quantitative observational studies 
• Prospectively plan for and deliver on key PCOS projects (qualitative, quantitative; COA, DHT, Patient Preference Information) to meet stage-gate, regulatory, and commercial milestones throughout the product lifecycle
• Lead PCOS publication planning strategy for PCOS-led activities

• Work with program manager to develop PCOS risk mitigation plans (i.e., identify risks, scenario planning, facilitate cross-functional input to enable decision-making) for assigned programs
• Coordinate PCOS-specific communication across cross-functional teams (CDT, IET, GRT, SET, AT)
• Collaborate with PCOS leadership on strategic department and organizational strategy development and execution
• Stay current on global best practices for PCOS strategy development and implementation

• Develop and integrate PCOS strategy into the CDP, IEP, and TPP
• Lead development of robust clinical outcome assessment (COA) endpoint strategy to support clinical development plans for assigned early- and late-stage programs
• Lead PCO strategy to be incorporated in the TPP
• Produce comprehensive PCOS Plans that are included in the IEPs
• Ensure fit-for-purpose clinical outcome assessment (COA) tools are selected and implemented in clinical trials and observational studies and that the study design and data analysis plans are optimized for interpretability
• Oversee PCOS project execution quality – propose, facilitate and implement plans to resolve issues and execute corrective actions
• Lead development strategy for de novo COA tool development
• Lead the design and execution of quantitative and qualitative PCO studies:
• Select and manage vendor bidding process
• Partner with legal, finance, and compliance teams to execute contracts and manage book of work
• Oversee CRO teams
• Oversee drafting and finalization of study materials, qualitative analysis plans (QAPs), statistical analysis plans (SAPs) and Psychometric Analysis Plans (PAPs)
• Oversee development of final study reports and dissemination deliverables
• Act as key SME:
• Drafting and finalization of PCOS components of interventional and non-interventional study protocols, and other qualitative and quantitative study protocols and Statistical Analysis Plans
• Authoring and reviewing PCOS-relevant sections of regulatory submission materials, site and KOL training materials, investigator and ad board meeting materials, study handbooks and other materials ensuring data and messaging accuracy and alignment
• Supporting PCOS strategy development and implementation for natural history and RWE evidence studies
• Organize and drive cross-functional working groups and teams to meet PCOS strategic objectives across the portfolio

• Represent PCOS on cross-functional teams and sub-teams
• Communicate PCOS information and activities to internal and external stakeholders (including senior leadership)
• Help develop and disseminate the most current PCO best practices throughout the organization (via email, presentations, desk procedures, reference documents and repositories) to foster enrichment and education of cross-functional stakeholders
• Represent PCOS on internal and external scientific and advocacy working groups
• Partner with various stakeholders to transition products from development to marketed stage and to fulfill post-marketing requirements
• Within cross-functional teams, foster a culture that promotes respect, teamwork, collaboration, openness, and appreciation

• A Master’s or doctoral degree in the field of Epidemiology, Public Health, Psychology, Psychometrics, Health Research, clinical (medicine, pharmacy or nursing) or related is required
• 5 + year experience with PhD; 8+ years with Master’s
• Experience in Patient Focused Drug Development, including Outcomes Research or other related function at a global pharmaceutical or biotechnology company, preferred. Experience interacting with regulators, policy makers, and experts in the field is preferred.

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.

The salary range for this position is: $156,600 to $234,800. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit: https://careers.biomarin.com/benefits.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.