Study Portfolio Strategy Lead provides pharmacoepidemiology expertise in regulatory and technical strategy for the Safety Surveillance Research (SSR) post-approval pharmacoepidemiology study portfolio, including regulatory communications, feasibility assessment, study design, and interpretation of study results, to ensure high quality and compliance with regulatory obligations and internal Pfizer requirements.ROLE RESPONSIBILITIES
- Ensures SSR deliverables are of high quality and in compliance with regulatory commitments and Pfizer policy and SOP requirements
- Drives continued innovation for epidemiologic and safety studies, implementing best-in-class approaches for study design, data collection and analysis and alignment with the evolving regulatory, scientific, and technological environment
- Works with SSR scientist and SSR Study Implementation Lead to design fit-for-purpose scientific and regulatory communication strategy for post-approval research activities
- Conducts detailed review of SSR deliverables for feasibility and technical quality prior to review and sign-off by Head of SSR
- Core member of technical review committee
- Collaborates with EUQPPV office on alignment of Pfizer policies and SOPs to legislation updates re: PASS and other post-marketing studies
- Participates on external working groups (e.g., leadership and membership in PhRMA, IMI, ISPE or other scientific bodies, scientific presentations and publications)
- Influences the external environment regarding best practices for safety epidemiological studies using real world evidence (e.g., scientific conferences and peer-reviewed journals)
- including but not limited to, partnering with regulatory agencies and academic opinion leaders, especially in the Asia/Pacific region
- Consults on the design, implementation and communication of key RWE safety studies outside the US/EU, such as safety studies conducted in the Asia-Pacific region
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.
- Doctoral degree in Epidemiology/Quantitative Public Health discipline or Doctor of Medicine (MD or equivalent) with a Master's degree in Epidemiology/Quantitative Public Health discipline with 15 years or more in Epidemiology in the pharmaceutical industry.
- 15+ years experience applying epidemiologic methods to study safety required.
- Excellent verbal and written communication skills in English required; excellent communication skills in an Asian language a plus.
- Educational or work experience in an Asian country strongly preferred
- Demonstrated ability to build and transform scientific/medical/operational teams in a complex matrix structure.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization regarding complex information and analysis.
- Ability to simultaneously manage multiple complex projects, effectively prioritizing and raising key issues as appropriate.
- Leading edge knowledge of the principles, concepts and theories of Epidemiology and advanced knowledge of principles and concepts of drug development and post-marketing safety assessment.
Technical Skill Requirements
Other Job Details:
- Demonstrated ability to develop above-asset regulatory and research strategies for safety assesment
- Experienced in support of compounds in all phases of drug development and commercialization. This includes leading development of and carrying out epidemiology research strategies for development projects and marketed products, implementing epidemiological studies and evaluations, and working on regulatory dossiers.
- Experienced in program oversight and internal and external communication
- Experienced in working with key external investigators, academics, vendors and health authorities
- Experience working in public-private partnerships or similar collaborations
- Demonstrated ability to achieve results in large matrix organizations
- Demonstrated ability to influence the direction of the discipline and its uses for regulatory and safety strategies
Last Date to Apply for Job: October 22nd, 2021
Additional Location Information: New York, NY; Collegeville, PA; Groton, CT; Peapack, NJ; Milan, Italy; Sandwich, UK; Cambridge, UK; Walton Oaks, UK
#LI-PFE 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.