Associate Director, Patient Centered Outcomes Science

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

Bio Marin 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.

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 novo COA tool development to fill evidentiary gaps.
• Serve as a 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 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: draft and finalization of PCOS components of interventional and non‑interventional study protocols,…