Pfizer

Global Pneumococcal Vaccines, Scientific Affairs Lead for China and Asia, MD

Employer
Pfizer
Location
Remote, California
Salary
Competitive
Posted
May 03 2021
Ref
4810896
Position Type
Full Time
Organization Type
Pharma
This position will assume a leadership and global role within the MDSCA pneumococcal vaccines asset, with a focus and direct responsibility for scientific work in China specifically and more broadly within developed countries of Asia (Taiwan, Japan, Korea, etc.). Work also will include supporting staff working outside of the global pneumococcal group in developing areas of Asia, such as Indonesia, The Philippines, and India. Within these regions, the position will have as a first priority supporting epidemiologic and other studies of pneumococcus and pneumococcal vaccines among the pediatric population of China, particularly studies required to achieve licensure or as Post Approval Commitment. These studies in the past have included disease burden and serotype distribution, carriage, immunogenicity, safety, and vaccine effectiveness. Similar studies may be of interest for informing adult pneumococcal vaccination in China. Additional projects may include studies in other areas of Asia related to adult and pediatric pneumonia and invasive pneumococcal disease surveillance, carriage and transmission, genomics, immunogenicity, immunology, and vaccine impact and effectiveness. The position will support primarily next generation vaccines under development (PCV20 and next-generation pneumococcal conjugate vaccines, PNG) but to the extent required also existing vaccines (PCV13 pediatric and adult). The position will have responsibility for overseeing and ensuring the scientific success of studies within the region of responsibility by working with Pfizer's Emerging Markets team (who has responsibility for China and developing areas of Asia), the International Developed Markets team (who has responsibility for developed Asian countries), as well as colleagues in global medical affairs, vaccine research and development, regulatory, commercial, public affairs, and health economics and outcomes research and in country with Development China group for all clinical projects related to China. Using medical expertise, the position will provide input into clinical aspects of studies such as clinical case definitions, clinical decision-making algorithms, antibiotic use and implications, interpretation of clinical outcomes, and safety. The position will work extensively with external partners - such as Gavi, WHO, local government officials, and local researchers - to provide input at all phases of studies (concept, design, protocol, assessment of implementation, interpretation, presentation and publication of results).This position will develop full expertise in the regulatory environment and requirements in China and will participate in the regulatory strategy including preparation for VCLT discussion, scientific revision to critical reports and medical documents for regulatory submissions and if needed interactions with CDE (China FDA) that could include consultation meetings, pre-CTA meetings or follow up meetings. The position will be supported by a Clinical Affairs team that has responsibility for study implementation, budget management and tracking, contracting, and statistics/analysis to ensure implementation success. This is a high-level position that requires skill and experience with field epidemiology, managing the scientific aspects of complicated long-term projects, interacting with world experts on pneumococcal disease and vaccine, experience operating in varied cultural settings, and integrating within a multi-disciplinary team at Pfizer. Depending on experience, interest, need and time availability, this position could also support other Pfizer vaccine assets in Asia such as meningococcal, coronavirus, RSV, and C. difficile vaccines.

ROLE RESPONSIBILITIES
  • Under the supervision of the Global Medical Lead for Pneumococcal Vaccines, and coordinating with the Emerging Markets team for China and developing countries of Asia, take the primary lead for developing the science related to pneumococcal vaccine (including PNG) public health decision-making and vaccine implementation in target regions of China and the remainder of Asia:
    • Act as the lead resource for ensuring integration of scientific information (epidemiology, carriage, disease burden, public health value, etc.) in the pneumococcal asset
    • Act as the lead resource for overseeing and coordinating scientific activities related to PNG ensuring integration of this information into the overall PNG development program
    • Define data gaps in target areas
    • Define research and data priorities
    • Lead epidemiology studies in the region - both field studies involving primary data collection and secondary analyses of real-world data.
    • Oversee the development of common strategies across study sites within the target regions and globally, including common protocols, case report forms, and databases
    • Develop innovative approaches to answering global questions related to pneumococcal disease as they apply to pneumococcal vaccines
    • Identify, establish, and maintain relationships with external partners that can collaborate with high priority global studies
    • Provide input to all aspects of study design (e.g., methodology, protocols, analytic plans) for high priority studies of importance for pneumococcal vaccine issues such as Vaccine Technical Committee recommendations, schedules, public payer options, relative value compared to other pneumococcal vaccines
    • Using medical expertise, assist with development of clinical case definitions, clinical decision-making algorithms, interpretation and assessment of clinical outcomes both for studies in Asia and globally as part of the global pneumococcal vaccines team.
    • Provide expertise to study team on how treatment policies and algorithms, particularly those related to antibiotic use, may affect study design and interpretation.
    • Provide expertise on vaccine safety concerns reported from Asia
    • Work with Epidemiology experts within Vaccines MDSCA and Emerging Markets to develop studies for post-licensure PNG vaccine effectiveness
    • Provide input into generic study designs that will be used globally for pneumococcal vaccine studies (e.g., surveillance methods; use of different diagnostic techniques such as chest x-rays; molecular methods; chest x-rays; carriage methods)
    • Assist with trouble shooting major scientific issues during study implementation, including through travel to study sites when appropriate
    • Work with internal and external experts in statistics and data analysis to analyze and interpret data from key pneumococcal vaccine studies.
    • Work with internal and external experts to publish data in peer-reviewed manuscripts, including taking the lead for writing the first draft of these manuscripts.
    • Work with internal and external experts to develop abstracts and present data for scientific congresses, including taking the lead for writing and presenting
    • Identify key topics appropriate for advisory boards related to pneumococcal vaccine issues (e.g., schedules, laboratory evaluation, carriage and transmission, public health burden)
  • Assist the global pneumococcal medical affairs team with developing various resources for internal use on science related to pneumococcal vaccines, with an emphasis on the target regions
  • Work with the Global Medical Lead and Scientific Affairs lead to define positions on global issues related to the science of pneumococcal vaccines and take the lead for publishing these positions.
  • Act as the initial scientific/epidemiology point of contact in the target regions for scientific questions related to pneumococcal vaccine commercial, regulatory, and policy issues and provide information/data to support internal staff working on commercial, regulatory, and medical affairs planning
  • Accountable for the collection of scientific data in target regions necessary for developing pneumococcal vaccine product labels.
  • Take the lead in writing original manuscripts each year (such as conceptual manuscripts, position manuscripts, systematic reviews, or where appropriate manuscripts based on original data).
  • Participate in the Epidemiology Sub-committee (ESC) and Medical Scientific Committee, both of which review external study proposals
  • Participate in the Pneumococcal Vaccine Leadership Team meeting


BASIC QUALIFICATIONS
  • Medical degree (MD) with experience and expertise in vaccinology and field-based epidemiology.
  • At least 10 years of experience in vaccine-related or vaccine-preventable disease related medical/scientific activities including research, clinical development, epidemiological, and immunization programs.
  • Recognized expert in vaccines or infectious diseases to be credible both internally and externally as evidenced by one or more of the following:
    • Lead or senior author of at least 5 peer-reviewed publications or book chapters
    • Principle or lead investigator for at least two major projects
    • Presenting author for at least 5 abstracts at international scientific congresses
  • Proven ability to interact with KOLs and Government officials dealing with immunization programs/vaccine policy and vaccine recommendations at the highest levels.
  • Demonstrated experience with participating in a matrixed team.
  • Demonstrated ability to lead across diverse cultures and geographies.
  • Significant cross-functional leadership experience.
  • Previous work experience on pneumococcal disease or vaccines
  • Documented ability to manage projects to completion.
  • Documented ability to take a relevant vaccine or vaccine-preventable disease project from start to end including conception, design, protocol, analytic plan, implementation, analysis, and reporting and interpretation of results.
  • Ability to understand subtle issues related to pneumococcal vaccinology and epidemiology
  • Able to review, evaluate, interpret, and present complex data; understand the emerging safety and efficacy profile of Pfizer pneumococcal vaccines
  • Understand the critical data elements related to assessing the public health value of pneumococcal vaccines, ability to oversee or conduct public health analyses of pneumococcal vaccine impact, and ability to interpret data and data limitations for both Pfizer and competitor pneumococcal vaccines.
  • Proficiency with MS-Office software (Word, Excel, Powerpoint)
  • Excellent verbal and written communication skills including scientific writing skills as evidence by lead authorship in at least 5 peer-reviewed publications in English
  • Strong interpersonal skills.
  • Proven ability to influence and succeed through others and to form excellent relationships with key cross-functional stakeholders.
  • Demonstrated strong work ethic, and proven track record of delivering high quality within timelines.
  • Willingness to travel (approximately 20%)
  • Fluent in English writing, reading, speaking
  • 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
  • Knowledge of immunization programs and groups such as Gavi/WHO, and an established network of KOLs within the vaccine field and relationships with established academic institutions
  • Knowledge of the commercial and environmental issues that drive pneumococcal vaccine development projects.
  • Ability to conduct independent data analyses and familiarity with a least one statistical software program (SPSS, Stata, R, etc.) (note that independent data analysis will not be part of the position's role)
  • Multiple languages a plus (particularly Mandarin or Japanese) but not required.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

20% travel

Other Job Details

Last Date to Apply for Job: May 10, 2021

Additional Location Information: This role can be based in Australia, New Zealand, Asia and U.S West Coast states (Pfizer site based and remote work option)

Eligible for Relocation Package : Yes

Eligible for Employee Referral Bonus

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.

Medical

#LI-Remote #LI-PFE

Similar jobs

Similar jobs