Associate Director, Patient Centered Outcomes Science

Role Summary

Associate Director, Patient Centered Outcomes Science. This role leads the end-to-end Patient Centered Outcomes (PCO) strategy within BioMarin's Global Medical Affairs, focusing on delivering regulatory, clinical, and patient access evidence. You will collaborate with clinical, regulatory, advocacy, commercial, and data science teams to plan and execute PCOS data generation, develop fit-for-purpose COA tools, and oversee publication and risk mitigation activities. The position supports cross-functional strategy development and requires remote or hybrid work with presence at the SRC (San Rafael) campus and the London office.

Responsibilities

• 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 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 subject matter expert 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 the program manager to develop PCOS risk mitigation plans 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 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 and implement plans to resolve issues and take corrective actions.
• Lead development strategy for de novo COA tool development.
• Lead the design and execution of quantitative and qualitative PCO studies, including selecting and managing vendor bidding processes, contracting with legal/finance/compliance, overseeing CRO teams, and overseeing materials (QAPs, SAPs, PAPs) and final study reports.
• Act as key SME: draft and finalize PCOS components of study protocols; author PCOS-relevant sections of regulatory submission materials and training materials; support RWE 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 to internal and external stakeholders; disseminate PCO best practices; represent PCOS in scientific and advocacy groups; partner to transition products from development to marketed stage and fulfill post-marketing requirements.
• Foster a collaborative, respectful, and performance-driven culture within cross-functional teams.

Qualifications

• Required: 5+ years of experience with PhD; 8+ years with Master’s.
• Preferred: Experience in Patient Focused Drug Development, including Outcomes Research or related function at a global pharmaceutical or biotechnology company; experience interacting with regulators, policy makers, and experts in the field is preferred.

Education

• 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.

Skills

• Strategic planning and program leadership for PCOS initiatives
• Cross-functional collaboration across clinical, medical, regulatory, advocacy, commercial, and data science teams
• Clinical outcome assessment (COA) strategy development and implementation
• Qualitative and quantitative research design and analysis; QAPs, SAPs, PAPs
• Vendor management and contract execution; CRO oversight
• Regulatory submissions support and RWE experience
• Effective communication with internal and external stakeholders