Supports the Meningococcal Vaccines Franchise Lead and Medical Leads in the development of a single, aligned global medical position on the data pertaining to MenACWY vaccines for communication internally and externally.
*Collaborates with the respective regional Team Leaders in developing product strategy and ensuring consistency of approach and deliverables for Global and Regional Medical Affairs activities.
Ensures that MenACWY vaccines medical plans are successfully developed and executed to achieve short- and long-term objectives and support the Global Medical plans for the Meningococcal Vaccines Franchise.
*Ensures clear cross-functional goals are established & agreed to support MenACWY vaccines.
*Partners with MenACWY commercial leads specifically and ensures alignment on key strategies, deliverables & communication.
*Serves as meningococcal vaccines champion, effectively negotiating with & influencing key internal & external stakeholders.
Responsibilities
*Supports the Medical Subcommittee for meningococcal vaccines and its functioning.
*Supports the oversight and execution (with the clinical affairs/devs operations/AP) of all clinical and epidemiological life cycle studies for Men vaccines with a focus on MenACWY vaccines
*Serves as subject matter expert for MenACWY and Meningococcal vaccines in general, and ensures consistency of communication of data, both internally and externally, by partnering with critical stakeholders within the Vaccines BU or the parallel customer facing organizations.
*Responsible for developing and updating as needed a risk:benefit assessment through the Product Benefit Risk Committee (P-BRC) for MenACWY assets.
*Responsible for the delivery of the appropriate communication of the risks and benefits of MenACWY vaccine globally.
*Support the Franchise and Medical Leads by providing medical contribution to required Health Hazard Assessment for any of the vaccines within the meningococcal vaccine portfolio.
*Supports the Franchise and Medical Leads with driving global consensus and alignment around the medical and scientific interpretation of the overall Meningococcal data set. Potentially leads team members and leverages additional line expertise to achieve the team goals.
*Co-responsible for the delivery of global medical activities in support of the men Franchise operating plan within time, cost and quality parameters. Assists with managing resources required to deliver such activities.
*Co-Responsible with Medical Lead to understand and facilitate all regional and local medical activities in support of the MenACWY vaccines specific components of the overall Meningococcal Vaccines Franchise operating plan.
*Contributes to the development of a global Phase IV strategy for Meningococcal vaccines by interfacing with countries and regions.
*Supports the Meningococcal Franchise lead in the management of internal relationships (i.e., commercial, regulatory, regions, etc.) and ensures adequate management of external relationships in collaboration with the appropriate team members (e.g. key opinion leaders).
*Serves as project champion by engaging with and effectively negotiating with key internal and external stakeholders.
*Manages key interdivisional interfaces on project issues including commercial and regional organizations.
*Co-responsible with the Franchise and Medical Leads for ensuring regionally aligned medical input to the global commercial strategy and implementation and for ensuring medical representation to the Asset Team and Global Review Committee.
*Contributes to the development of publication strategy and implementation.
Qualifications
*Medical degree with experience in vaccinology, infectious disease epidemiology, vaccine clinical development and medical affairs
*At least 5 years of experience in vaccine-related medical/scientific activities including laboratory research, clinical development, epidemiological, and immunization programs.
*Vaccine and infectious disease area expertise to be credible both internally and externally.
*Ability to interact with KOLs and Government officials dealing with immunization programs/vaccine policy and vaccine recommendations at the highest levels.
*Demonstrated experience in leading a matrixed team.
*Demonstrated ability to lead across diverse cultures and geographies.
*Significant cross-functional leadership/management experience. Demonstrated excellence in leadership behavior.
*Knowledge of immunization programs and an established network of KOLs within the vaccine field and relationships with established academic institutions
*Knowledge of the commercial and environmental issues that drive development vaccine projects.
*Demonstrated ability in the design, initiation, and reporting of clinical studies as part of an integrated clinical plan.
*Prior experience in medical monitoring of clinical trials advantageous
*Proven ability to influence and succeed through others and to form excellent relationships with key cross-functional stakeholders.
PHYSICAL/MENTAL REQUIREMENTS
*Able to discuss scientific aspects of vaccine development regulatory issues and also comfortable in discussing commercial issues.
*Able to review, evaluate, interpret, and present complex data; understand the emerging safety and efficacy profile of the vaccine candidate, including providing a perspective with comparator vaccines.
*Excellent verbal and written communication skills including scientific writing skills and strong interpersonal skills.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Willingness to travel internationally as required to support medical activities with regional colleagues, External KOLs and attendance at relevant international congresses
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