Role summarylead end-to-end patient centered outcomes (pco) strategy and evidence generation across development to post-market for biomarin products. Collaborate with cross-functional partners to deliver data that meets regulatory, clinical, and patient access needs. Manage development and deployment of coa tools and pcos studies. Location: remote or hybrid in src (san rafael campus) and london.responsibilitiesstrategy & planningcollaborate 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 needsidentify, select, and implement fit-for-purpose coa tools in the interventional and non-interventional studies to support regulatory approval, labeling claims, and commercial successdrive de novo coa tool development to fill evidentiary gapscontribute as key sme for qualitative and quantitative observational studiesprospectively 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 lifecyclelead pcos publication planning strategy for pcos-led activitiesoperational executiondevelop and integrate pcos strategy into the cdp, iep, and tpplead development of robust clinical outcome assessment (coa) endpoint strategy to support clinical development plans for assigned early- and late-stage programslead pco strategy to be incorporated in the tppproduce comprehensive pcos plans that are included in the iepsensure 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 interpretabilityoversee pcos project execution quality – propose, facilitate and implement plans to resolve issues and execute corrective actionslead development strategy for de novo coa tool developmentlead the design and execution of quantitative and qualitative pco studies:select and manage vendor bidding processpartner with legal, finance, and compliance teams to execute contracts and manage book of workoversee cro teamsoversee 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 deliverablesact as key sme:drafting and finalization of pcos components of interventional and non-interventional study protocols, and other qualitative and quantitative study protocols and sapsauthoring 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 alignmentsupporting pcos strategy development and implementation for natural history and rwe evidence studiesorganize and drive cross-functional working groups and teams to meet pcos strategic objectives across the portfoliocross-functional influencerepresent pcos on cross-functional teams and sub-teamscommunicate 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 stakeholdersrepresent pcos on internal and external scientific and advocacy working groupspartner with various stakeholders to transition products from development to marketed stage and to fulfill post-marketing requirementswithin cross-functional teams, foster a culture that promotes respect, teamwork, collaboration, openness, and appreciationqualificationsa master’s or doctoral degree in the field of epidemiology, public health, psychology, psychometrics, health research, clinical (medicine, pharmacy or nursing) or related is required5 + year experience with phd; 8+ years with master’sexperience 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. #j-18808-ljbffr