• Collaborate with key cross-functional stakeholders (e.g., clinical, medical, regulatory, advocacy, commercial, global study operations, data science) • 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.