Senior Director, Real-World Evidence and Epidemiology, Pneumococcal Vaccines

Senior Director, Real-World Evidence and Epidemiology, Pneumococcal Vaccines

• United Kingdom - Cambridge
• United States - Washington - Bothell
• United States - New York - New York City
• United States - Pennsylvania - Collegeville
• United States - Massachusetts - Cambridge

We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place. To fully realize Pfizer's purpose - Breakthroughs that change patients' lives - we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

This position will assume a leadership and global role within the Vaccines Real-World Evidence (RWE) and Epidemiology group, Bacterial and Vector Borne Disease Team, with a focus on pneumococcal conjugate vaccines (PCVs). The senior director will lead RWE and epidemiologic studies generating evidence on disease burden, vaccine effectiveness, and vaccine impact to support the pneumococcal franchise. Evidence generated from these studies will be used to inform vaccine recommendations and utilization of licensed PCVs and the development and licensure of next-generation PCVs.

This is a high-level position that requires skill and experience with field epidemiology, infectious disease surveillance, and database studies. The role will involve managing the scientific aspects of complicated long-term projects, interacting with external experts on pneumococcal disease and vaccines, and integrating within a multi-disciplinary team at Pfizer. This position is part of a newly formed Vaccines RWE/epidemiology team and will work cross-functionally with collaborators spanning PCV Medical teams, Research Units, and the Chief Medical Officer organization (Medical Evidence Generation, Regulatory, Safety, Data Sciences & Analytics, Medical Enablement & Quality) to design, execute, and disseminate results from studies. Example studies include those focused on burden of disease and serotype distribution, as well as studies to evaluate the effectiveness and impact of PCV20 on disease outcomes, including Phase 4 effectiveness studies conducted as post-approval commitments for regulatory agencies. Because the PCV asset resides within Bacterial and Tick-Borne Diseases group, the position may also work on related pipeline vaccines.

Role Responsibilities

In this role, you will:

• Lead epidemiology studies- both field studies involving primary data collection and secondary analyses of real-world data.
• Author and review study protocols, reports, presentations (internally and at scientific conferences), and peer-reviewed manuscripts.
• Provide input to all aspects of study design (e.g., methodology, protocols, analytic plans) for high priority epidemiologic and other scientific studies of importance for pneumococcal vaccine issues such as Vaccine Technical Committee recommendations, schedules, public payer options, relative value compared to other pneumococcal vaccines.
• Develop innovative approaches to answering global questions - primarily those related to epidemiology - related to pneumococcal disease as they apply to pneumococcal vaccines.
• Identify, establish, and maintain relationships with external partners that can collaborate on high-priority global studies.
• Work with internal and external experts in statistics and data analysis to analyze and interpret data from pneumococcal vaccine studies.
• Be accountable for the collection of epidemiologic and other scientific data necessary for developing pneumococcal vaccine product labels.
• Provide subject matter expertise and thought leadership to advance Pfizer's use of RWE/Epi for regulatory purposes and to develop high-value vaccines.

Qualifications

• Advanced degree, including a PhD in Epidemiology or a related discipline and 7+ years of relevant experience in the pharmaceutical, academic and/or medical or public health environments; an MD with 5+ years of relevant experience as previously stated; or an MPH or another relevant Master's degree and 10+ years of relevant experience previously stated.
• Subject matter expertise in vaccinology and infectious disease epidemiology.
• Strong epidemiological and statistical methods skills used in observational and non-interventional studies.
• At least 5 years of experience in vaccine-related or vaccine-preventable disease related medical/scientific activities including research, clinical development, epidemiological, and immunization programs.
• Experience operating within large cross-functional matrices and collaborating with multiple partners.
• Strong technical expertise, analytic ability, creative problem-solving, and communication skills.
• Proven hands-on experience leading and executing non-interventional (NI) studies from protocol design, delivery of results and clinical study report.
• Experience directing analyses of real-world data, for example using large databases from health care systems containing ICD-10 codes or claims data.
• Excellent verbal and written communication skills including scientific writing skills as evidenced by lead authorship in at least 5 peer-reviewed publications in English.
• Strong interpersonal skills.
• Demonstrated strong work ethic, and proven track record of delivering high quality results within timelines.
• Able to review, evaluate, interpret, and present complex data and understand the emerging safety and efficacy profile of Pfizer pneumococcal vaccines.
• Significant cross-functional leadership experience.
• Documented ability to manage projects to completion.
• Documented ability to take a relevant vaccine or vaccine-preventable disease epidemiology project from start to end including conception, design, protocol, analytic plan, implementation, analysis, and reporting and interpretation of results.

Role Summary

This position will assume a leadership and global role within the Vaccines Real-World Evidence (RWE) and Epidemiology group, Bacterial and Vector Borne Disease Team, with a focus on pneumococcal conjugate vaccines (PCVs). The senior director will lead RWE and epidemiologic studies generating evidence on disease burden, vaccine effectiveness, and vaccine impact to support the pneumococcal franchise. Evidence generated from these studies will be used to inform vaccine recommendations and utilization of licensed PCVs and the development and licensure of next-generation PCVs.

This is a high-level position that requires skill and experience with field epidemiology, infectious disease surveillance, and database studies. The role will involve managing the scientific aspects of complicated long-term projects, interacting with external experts on pneumococcal disease and vaccines, and integrating within a multi-disciplinary team at Pfizer. This position is part of a newly formed Vaccines RWE/epidemiology team and will work cross-functionally with collaborators spanning PCV Medical teams, Research Units, and the Chief Medical Officer organization (Medical Evidence Generation, Regulatory, Safety, Data Sciences & Analytics, Medical Enablement & Quality) to design, execute, and disseminate results from studies. Example studies include those focused on burden of disease and serotype distribution, as well as studies to evaluate the effectiveness and impact of PCV20 on disease outcomes, including Phase 4 effectiveness studies conducted as post-approval commitments for regulatory agencies. Because the PCV asset resides within Bacterial and Tick-Borne Diseases group, the position may also work on related pipeline vaccines.

Role Responsibilities

In this role, you will:

• Lead epidemiology studies- both field studies involving primary data collection and secondary analyses of real-world data.
• Author and review study protocols, reports, presentations (internally and at scientific conferences), and peer-reviewed manuscripts.
• Provide input to all aspects of study design (e.g., methodology, protocols, analytic plans) for high priority epidemiologic and other scientific studies of importance for pneumococcal vaccine issues such as Vaccine Technical Committee recommendations, schedules, public payer options, relative value compared to other pneumococcal vaccines.
• Develop innovative approaches to answering global questions - primarily those related to epidemiology - related to pneumococcal disease as they apply to pneumococcal vaccines.
• Identify, establish, and maintain relationships with external partners that can collaborate on high-priority global studies.
• Work with internal and external experts in statistics and data analysis to analyze and interpret data from pneumococcal vaccine studies.
• Be accountable for the collection of epidemiologic and other scientific data necessary for developing pneumococcal vaccine product labels.
• Provide subject matter expertise and thought leadership to advance Pfizer's use of RWE/Epi for regulatory purposes and to develop high-value vaccines.

Qualifications

• Advanced degree, including a PhD in Epidemiology or a related discipline and 7+ years of relevant experience in the pharmaceutical . click apply for full job details