Pfizer Vaccines has a very active vaccine pipeline and is currently developing several vaccines. This position is to join the COVID vaccine program and/or the RSV vaccine program. Both are conducting large vaccine efficacy studies. This position would provide an opportunity to join a very dynamic team as physician/medical monitor and work on clinical trials and other related vaccine development work.
Pfizer’s Pearl River site has been involved in vaccine development for over 100 years. Currently, hundreds of staff at the site support Pfizer’s large vaccine pipeline as well as its approved vaccines creating a large vibrant professional community committed to vaccine development. The site is in commuting distance of Westchester County NY, upper Manhattan, and Bergen County NJ.
Role Summary
The Clinician Medical Monitor (CMM) is accountable for providing medical and scientific expertise and oversight for Global Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies to ensure patient safety. Additional study level activities include presentation of study results to internal and external committees or advisory boards, presentation of data at international scientific meetings and publication of study results in peer-reviewed journals.
The CMM will also act as a medical monitor for select clinical trials, including phase 2B and phase 3 registration studies, The CMM is accountable for patient safety for subjects participating in Pfizer clinical trials and provides medical guidance during the design, execution, and reporting for clinical studies.
In addition to study level activities, the CMM will participate in program level activities including authoring/reviewing safety and efficacy summaries, clinical overviews, investigator brochures, risk management plans, periodic safety update and clinical sections of product labels.
In addition to work on specific assets the CMM will participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews, and provide assistance to new business development on market opportunities and the target product profile.
Role Responsibilities
DESIGN PROTOCOL AND STRATEGY
PROVIDE STUDY TEAM WITH MEDICAL EXPERTISE DURING KEY ACTIVITIES
ACCOUNTABLE FOR SAFETY ACROSS THE STUDY
STUDY LEVEL DATA REVIEW
ANSWER AND RESOLVE MEDICAL AND SAFETY QUESTIONS FROM SITES
CONTRIBUTE TO ORGANIZATION OF KEY STUDY REVIEW COMMITTEES AND SUPPORT THE FUNCTION OF THE COMMITTEE ACTIVITIES
PRESENTATIONS AND PUBLICATIONS OF CLINICAL TRIAL RESULTS
Qualifications
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.
Other Job Details:
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.