Director, Core Brands & Pipeline nonMD

The Medical Affairs (MA) Director, Core Brands & Pipeline is an integral member of the CV/Metabolism and Core Brands team reporting to the US MA Team Leader. The Director combines the medical expertise and understanding of the patient's and physician's point of view for the Core Brands and provides medical leadership and US product strategy in support of pro-active product maintenance and product defense initiatives as well as pipeline asset(s). The Director will also partner with Global MA on pipeline assets that require input from NA medical. The Director is part of a cross-functional environment where colleagues always understand and exhibit customer-focused medical professionalism with honor and integrity.

• Provides strategic medical oversight and leadership for overall (planned and adhoc) product maintenance and defense activities for the Core brands in US
• Provides medical leadership on Cross-Functional Medical Evaluation Committee ensuring a comprehensive assessment of the potential impact of amendments in product labeling for the overall benefit /risk of the product
• Provides medical affairs support to the Cross Pfizer BU HHA strategic initiatives as product expert
• Provides medical input and assessment of critical medicines in collaboration with PMC for the medically necessary products project for the US
• Provides medical input and review of clinical overviews and clinical efficacy section in support of PBRERs, ACOs, PSURs, ARs, product renewals etc
• Supports evaluation of Pfizer global supply (PGS) issues
• Partners with PGS, Regulatory, Safety, Legal, Communications and Medical Information on product inquiries, press releases and letters involving supply interruption or out of stock situations for Core brands in the US
• Supports PBRCs and present assessment of clinical efficacy at PBRCs, BU-BRCs and E-BRCs
• Supports reformulation efforts, reviews the abbreviated and supplemental submissions (aNDAs, sNDa, MMAs, aMMAs) and contributes to the rapid response teams
• Partners with the peri LOE team on US product transfers and team deliverables
• Provides subject matter expertise for product PLR conversions, RMP, REMS, label harmonization, and external and internal audits in the US as needed
• Collaborates with Global Medical Affairs, and as appropriate, Commercial Development, Clinical Development, research, and other cross-functional teams in setting the US strategic direction for the pipeline asset(s)
• Works within cross functional teams to develop a common interpretation of data, a shared understanding of how product attributes drive realistic product profiles and broad buy-in to the development strategies most likely to achieve optimal labeling, access, and pricing
• Contributes to the planning and timely, high quality execution of medical tactics in support of US pipeline asset(s)

BASIC QUALIFICATIONS

Education

• PhD, PharmD with a minimum of 7 years of industry experience

Experience

• Experience in medical affairs
• Ability to work successfully with cross-functional colleagues, including commercial
• Excellent interpersonal skills
• Ability to work well on multiple tasks and effectively prioritize
• Ability to manage a large and diverse portfolio of products
• Customer focus with patient safety first mindset
• Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture
• Uses his/her time effectively and efficiently
• Fluent in written and spoken English; excellent communication and presentation skills
• 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.
  

PREFERRED QUALIFICATIONS

• Experience supporting Pfizer Core Brands and/or pipeline asset
• Experience working with external scientific experts
• Experience with regulatory and/or safety risk management issues
• Knowledgeable about how organizations work; knows how to get things done both through formal channels and the informal network

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel: approximately ~20%

Other Job Details:

Last Date to Apply for Job: June 30th, 2021

Eligible for Employee Referral Bonus

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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.

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