US Medical Director – Anti-Infectives Portfolio, MD

ROLE RESPONSIBILITIES

• Provide medical and operational oversight and leadership on key medical activities for the Anti-Infectives portfolios
• Responsible for all US-based regulatory and safety activities related to the Anti-Infectives portfolios in collaboration with the GMPE Leads
• Provide critical review of Medical Education Grants and Investigator Initiated Research proposals
• Serve as a Medical resource to HQ Medical Affairs, other Field Medical colleagues, and external Therapeutic Area investigators and researchers as appropriate
• Provide subject matter expertise and strategic leadership on reformulation efforts, abbreviated and supplemental submissions (aNDAs, sNDa, MMAs, aMMAs) and rapid response teams to assure appropriate support for US business deliverables
• Provide medical leadership/partnership in the management of safety issues and safety letters
• Partner with WPM, Pharm Sci, and Clinical Affairs in the coordination of clinical oversight of FDA-mandated post marketing studies
• Provide critical review and medical input, review and approval of promotional materials through the Review Committee
• provide medical input and review of launch materials; participate in launch activities such as field force training
• Partner with finance on budget planning and management
• Work closely with Field Medical team to help direct medical outreach activities and content creation
• Engage effectively in the knowledge transfer processes and synthesize large amounts of data/product information during the transition of products from Pfizer Therapeutic Area teams or from external acquisitions
• Manage any US medical peri-LoE strategy for anti-infectives, constructively engaging other business units as required
• Compliant with all required SOPs and compliance training
• Provide technical and scientific evaluation of Licensing and Acquisition and Business Development candidates and product enhancements in close collaboration with NA Commercial Development.
• Monitor global trends to identify opportunities for the assets in the portfolios.
• Coordinate external stakeholder interactions and activities.
• Provide oversight of medical and scientific activities of the Team.
• Embed medical professionalism and enhance the formation of a medical community across Hospital BU

Qualifications

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop, and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

• M.D., DO or equivalent
• 3+ years of experience
• Broad expertise in medical marketing and strong experience with regulatory and/or safety risk management issues.
• Experience in collaborating with internal and external stakeholders
• Experience in surgery or related discipline in hospitals
• Demonstrated ability to rapidly adopt and utilize new digital technology and other resources with medical customers and record medical interactions
• Familiarity with internal/external SOPs/Rules/Regulations regarding Pfizer/customer interactions and relationships, etc.
• Demonstrated expertise in oversight of medical affairs programs in late phase development or post-approval in the pharmaceutical industry.
• Industry expertise in the relevant disease area.
• Expertise in the disease area with an established KOL network.
• Successfully initiated and executed a major post approval medical program.
• Successfully interacted with regulatory agencies regarding indication and/or labeling issues.
• Knowledgeable of the commercial and environmental issues that drive asset success.
• Experienced in managing projects to completion (with demonstrated fiscal responsibility).
• Ability to analyze, review and interpret bodies of data.
• Search appropriate data bases/systems for clinical data and/or information.
• Develop verbal and/or written arguments in a logical and cogent manner.
• Demonstrated ability to work effectively on Review Committees
• Business acumen and experience in product growth activities, including product launch activities; knows the industry; knowledgeable in current and possible future trends, technology, and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace
• Creativity, integrity, and ability to work in a fast paced, flexible and focused environment
• Organizational Agility- Knowledgeable about how organizations work; knows how to get things done both through formal channels and the informal network; understands the origin and reasoning behind key policies, practices, and procedures; understands the cultures of organizations.
• Proactive, pragmatic, flexible person with excellent leadership qualities, strategic thinking, communication & presentation skills

Other Job Details:

• Last Date to Apply for Job ​: 06/30/2022
• Eligible for Employee Referral Bonus

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer 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. Pfizer 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. Pfizer is an E-Verify employer.