Senior Director Medical Affairs

Overview We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio. What You Will Do Leadership of the Medical Affairs OrganizationPeopleProactively manage and develop talent, while identifying new opportunities vs. emerging needs by reallocating resources, upskilling the team and recruitingCreate an empowering, compliant, collaborative, and innovation-focused work environmentBuild a culture of quality and compliance through training, oversight, and collaborationCountry Medical Affairs Plans (CMAPs)Strategically develop, execute, and deliver CMAPs, including tactical deliverables for each therapeutic area, such as post-licensure research, publication plans, investigator-initiated studies, and other knowledge transfer activitiesEnsure alignment of the CMAPs with global strategy and adherence to all relevant regulations, Policies and Standard Operating Procedures (SOPs)Manage the country-developed Protocol Concept Sheets (PCS), obtain regional and global approvals for new local data generation activities, and manage their executionMedical Affairs ManagementProvide oversight to the country medical information team, establish processes and systems to ensure that medical information requests (MIRs) from healthcare professionals are addressed in a timely manner and in alignment with the global scientific response documents and training materialsManage approved operating administrative (e.g., salaries & travel) and life cycle management budget (e.g., advisory boards, local data generation, etc.)Oversees all activities of local medical department employeesOversees inspections and inspections audits, answering inquiries by health authorities, ethical committees, and internal auditors in conjunction with Regulatory, Pharmacovigilance (PV) and Global Clinical Trial Operations (GCTO)Collaboration With Key Internal StakeholdersYou will represent Medical Affairs in cross-functional leadership teams and collaborations and advocate for the interests of the country with regional and global colleaguesCountry (or Cluster) Leadership TeamRepresents Medical Affairs and is the "medical voice" in the country executive management teamGlobal Clinical Development (GCD), Global Clinical Trial Operations (GCTO), and Global Clinical Scientific Affairs (GCSA)Support GCTO when requestedManage the submission and our roles in the conduct of investigator-initiated studiesLead country review of Compassionate Use Requests and Pre-License Patient Access (PLPA) programs and facilitates Chief Medical Officer (CMO) approval of these requestsOutcomes Research (OR), Market Access, Regulatory Affairs, HH, and PolicyInteract with OR, Market Access, and Global Medical Affairs experts to develop and manage observational, real-world effectiveness and epidemiologic studiesCollaborate with OR, market access, regulatory and commercial colleagues by providing scientific expertise and managing the medical aspects of submissions for regulatory, reimbursement or tenders for our company's entire portfolio of medicines and vaccinesProvide medical expertise to the commercial product teams, ensuring the scientific and medical value of our company's products across all therapy areasEngagement With Key External StakeholdersServes as external interface with key stakeholders, insurers/government leaders, selected professional societies, medical-scientific institutions, and the broader scientific community to lead and execute the medical research and implementation strategy for our company's innovative medicines, ensuring that the medical community is appropriately engaged with the information they need to support patient care needs (e.g., scientific advisory boards, scientific leader engagements, webinars, and presentations)Collaborates with OR, Market Access, and Commercial colleagues to engage payers, policymakers, and other decision makers in support of our company's