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All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Provides leadership on behalf the US Medical Affairs team. The position will focus on the Meningococcal B vaccine, with additional effort across franchise assets dependent on business needs.
Primary efforts will be assigned to Lead the US Medical Affairs program on the Meningococcal B vaccine and any other meningococcal vaccine.
• Collaborates with the respective Brand Team Leaders in developing product strategy and ensuring consistency of approach and deliverables for US Medical Affairs activities.
• Ensures that US medical plans supporting the asset(s) are successfully developed and executed to achieve short- and long-term objectives.
• Champions US needs and priorities for their asset(s).
• Ensures clear cross-functional goals are established & agreed to.
• Accountable for US Medical Plans.
• Accountable for delivery of US Development and Lifecycle Plans and US Medical Strategies.
• Partners with Men B commercial leads and ensures alignment on key strategies, deliverables & communication.
• Serves as US project champion, effectively negotiating with & influencing key internal & external stakeholders.
• Key point of accountability in the US for all inquiries and communications regarding the medical / development aspects of the asset.
• Ensures US Medical Affairs activities are fully supported and establishes focused partnership with regional teams/colleagues.
• Business Plan Development: Leads the development of strategies and tactics to support Asset needs, and ensures delivery of Medical Plans for the assets. Oversees and coordinates medical input into brand strategies and tactics ensuring US medical needs are met.
• Sales Training: Support POAs and US Sales training needs through partnership in developing materials and provide expert medical presentations and education. Support development of training modules.
• Commercial support: Partners with US commercial team to provide medical input and review and is accountable to ensure alignment on US key strategies, US deliverables & US communication.
• Publication Subcommittee (PSC) Membership: Collaborate with Clinical Development and Clinical Affairs global colleagues on key governance committee to support development of a strategic global and regional publication plans, participate in data analysis efforts, and lead or participate in manuscript, abstract, and poster development.
• Regulatory Support: Provides US medical support and guidance for label updates and responses to regulatory requests.
• Safety Support: Provides US medical support, analysis, guidance for safety updates, issues pertaining to regional business.
• Customer Insight Planning: Provides leadership for the development and implementation of Customer Insights Plans including medical Advisory Boards to gather expert guidance to advise medical planning. Provides US input into global Advisory Board planning and supports implementation and presentations (as needed).
• Medical Subcommittee Membership (MSC): Represents US Medical Affairs on key governance committee. Collaborates with Clinical Development and Clinical Affairs global colleagues to support development of global medical strategies. Manages regulatory and safety issues.
• Publication Subcommittee (PSC) Membership: Partners with Clinical Development and Clinical Affairs global colleagues on key governance committee to support development of a strategic global and regional publication plans.
• Medical Customer Planning: Leads the engagement of HQ Medical Team with the external community including KOLs and other external stakeholders to ensure that medical strategies reflect customer needs.
• Medical Affairs Alignment: Ensures effective cross-functional alignment in customer facing activities and represents the company externally in the therapeutic area.
• Coordinates and participates in key Medical Affairs activities including MA input for regulatory interactions and safety updates.
• Internal Communication: Represents the US team in internal forums, ensuring US needs are considered and represented in global strategies and plans. Develops and strengthen partnerships among key stakeholders.
• Field Based Medical (Regional Medical Research Specialists) Partnership: Leads the partnership with US Field Based Medical teams to align field and HQ regional team activities to ensure development of operational plans. Provides product insight and education and external interaction plans.
• Outcomes Research Partnerships: Leads partnership with Outcomes Research and Institutional OR Scientists to develop strategies and design research to support regional business.
• Build organizational capability: Builds trust among team members and broader stakeholders by setting a highly visible example of medical excellence.
• Advanced degree, PhD, and/or PharmD or equivalent qualifications required.
• Expertise in Vaccines and Disease area (Meningococcal B).
• 10+ years Pharmaceutical experience preferred.
• Highly motivated with demonstrated track record of high performance and producing outstanding results.
• Capable of comprehending and communicating in a clear, concise manner a large amount of scientific information.
• Proven ability to facilitate open discussion and debate among key stakeholders and build internal and external relationships through partnering, anticipating needs, fulfilling expectations.
• Very strong strategic skills including creativity and effectiveness in proactively identifying and addressing challenges.
• Significant cross-functional leadership/management experience.
• Demonstrated excellence in leadership behavior.
• Expertise in vaccines and Immunization programs with an established international KOL network.
• Knowledgeable of the commercial, regulatory, policy and environmental issues that drive immunization.
• Experienced in managing projects to completion including management budgets (with demonstrated fiscal responsibility).
• 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. Publications in internationally renowned medical peer-reviewed journals would be a distinctive advantage.
• Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to set budgets.
• Proven ability to influence and succeed through others and to form excellent relationships with key cross-functional stakeholders.
• Demonstrated strong work ethic, and proven track record of delivering high quality within timelines.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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