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As part of the BioMarin Integrated Evidence Function in the Global Medical Affairs department, the Patient Centered Outcomes Science organization is responsible for the successful development and execution of end-to-end Patient Centered Outcomes strategy— delivering evidence that meets regulatory, clinical, and patient access needs.
Job Responsibility:
Lead PCOS data and evidence generation planning and execution
Identify, select, and implement fit-for-purpose COA tools in interventional and non-interventional studies
Drive de novo COA tool development
Contribute as key subject matter expert for qualitative and quantitative observational studies
Prospectively plan for and deliver on key PCOS projects
Lead PCOS publication planning strategy
Work with program manager to develop PCOS risk mitigation plans
Coordinate PCOS-specific communication across cross-functional teams
Collaborate with PCOS leadership on strategic department and organizational strategy development
Stay current on global best practices for PCOS strategy
Develop and integrate PCOS strategy into the CDP, IEP, and TPP
Lead development of robust clinical outcome assessment endpoint strategy
Lead PCO strategy to be incorporated in the TPP
Produce comprehensive PCOS Plans
Ensure fit-for-purpose COA tools are selected and implemented
Oversee PCOS project execution quality
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
Oversee CRO teams
Oversee drafting and finalization of study materials
Act as key SME for drafting PCOS components of study protocols and regulatory submissions
Support PCOS strategy for natural history and RWE evidence studies
Organize and drive cross-functional working groups
Represent PCOS on cross-functional teams
Communicate PCOS information to internal and external stakeholders
Help develop and disseminate PCO best practices
Represent PCOS on internal and external scientific and advocacy working groups
Partner with stakeholders to transition products from development to marketed stage
Foster a culture that promotes respect, teamwork, collaboration, openness, and appreciation
Requirements:
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
What we offer:
Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans