Pfizer

Global Medical Affairs Lead, C. difficile Vaccine (MD)

Employer
Pfizer
Location
Collegeville, Pennsylvania
Salary
Competitive
Posted
January 12 2021
Ref
4802227
Position Type
Full Time
Organization Type
Pharma
The Global Medical Affairs Lead for C. difficile Vaccine is responsible for designing and executing the medical strategies leading to the licensure and introduction of the Pfizer C. difficile vaccine. This includes developing the evidence generation strategy, engaging external stakeholders, and collaborating with VRD and BU cross-functional teams to optimize medical benefit and support vaccine recommendations globally.

The Global Medical Affairs Lead for C. difficile vaccine is the lead for engaging the worldwide medical community to identify the unmet medical need for C. difficile vaccine. He/she will manage relationships and actively build networks with key opinion leaders in the infectious diseases and vaccinology field, Vaccine Technical Committees (VTCs), healthcare policy makers, and payers, to obtain strategic input and establish research partnerships. He/she will develop a multi-disciplinary research agenda that clearly defines the burden of CDI, target age groups, risk factors, and outcomes and includes vaccine effectiveness and other post-licensure evaluations. He/she will develop vaccine target product profiles with cross-functional partners, provide input on the clinical program needed to obtain recommendations / reimbursement, and contribute to the regulatory strategy to optimize vaccine label. He/she will collaborate with commercial and market access teams to develop appropriate, scientifically accurate marketing and access strategies, and propose medical tactics to support these activities.

This is a dynamic role that requires a firm understanding of the epidemiology of infectious diseases, vaccine preclinical and clinical development, as well as the ability to objectively interpret technical and commercial information in order to optimize clinical development as well as lifecycle strategies. Leadership for local licensing and VTC recommendations are also needed.

ROLE RESPONSIBILITIES
  • Works closely with WRD to identify the unmet medical need for C. difficile vaccine and develops a cross-functional multi-disciplinary research agenda including epidemiology, clinical trials, outcomes research, policy, and implementation operationalized by clinical affairs/development operations/statistics/HEOR and subject matter experts
  • Ensures clear cross-functional goals are established & agreed to.
  • Operationalizes various evidence generation activities including exploration of research collaborations, independent research support, preparing study data for medical queries, analysis and interpretation of data.
  • Acts as key point of accountability for all scientific inquiries and communications regarding the C. difficile vaccine program.
  • Works closely with the Scientific Affairs Lead C. difficile vaccine to develop a holistic medical affairs plan where all the evidence generating activities are fully integrated and operationalized.
  • Primary responsibility to review all regulatory documents for C. difficile vaccine.
  • Defines overarching strategic portfolio opportunities and objectives for near, mid, and long term for C. difficile vaccine
  • Ensures strategic alignment between BU and WRD in defining product concepts, supports POM/POC development paths and participates in Program Strategic Groups for early candidates.
  • Provides medical input to clinical trial and safety study protocols.
  • Is responsible for proactively keeping up to date and informing the Vaccines BU team of new clinical/scientific activities by competitors (e.g. new, relevant clinical trials disclosed in the public domain, emerging data, etc.).
  • Creates the publication strategy/implementation for C. difficile vaccine in partnership with internal and external research groups.


Basic qualifications
  • MD with 10 or more years experience
  • At least 4 years of medical and scientific experience in vaccines, essential.
  • Able to influence and succeed through others. Able to form excellent relationships with key stakeholders in BU and WRD.
  • Demonstrated ability in the design, initiation, and reporting of clinical studies as part of an integrated clinical plan.
  • 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.
  • Strong work ethic and proven track record of delivering high quality within timelines.
  • Entrepreneurial and motivated to challenge dogma and the status quo.
  • Innovative in identifying new opportunities and finding new ways to create value.


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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Regular travel within the US and internationally to interact with local Pfizer teams and external investigators, meet with key stakeholders, attend conferences, etc.

Last Date to Apply for Job: January 19th, 2021

Additional Location Information: This position can work remotely/on site in the U.S or Europe

Eligible for Employee Referral Bonus

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Sunshine Act

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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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