Associate Director, Clinician Medical Monitor (MD Required)

Pfizer - Pearl River, NY (30+ days ago)4.2


Pfizer Vaccines is developing an investigational S. aureus vaccine and currently conducting a large vaccine efficacy study among adults undergoing spinal fusion surgery. For more information, please see the study website: https://strivestudy.com/ This position would provide an opportunity to join the S. aureus vaccine 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

In collaboration with GCPL, and Pfizer Vaccine Clinical Research and Development Operations colleagues and Alliance Partners, conduct the design of clinical studies to meet the stated objectives. Directs Clinical Scientists (CSs) in writing the synopsis and protocol
Approve and be accountable for protocols and amendments
Approve informed consents
Provide medical input into investigational site feasibility
Coordinate with the CS to review and approve processes for data capture and review
In conjuction with GCPL and Pfizer colleagues, organizing expert panels or consultant or advisory board meetings to provided input into clinical development plans, protocols and data analyses
PROVIDE STUDY TEAM WITH MEDICAL EXPERTISE DURING KEY ACTIVITIES

Protocol training for investigators
Issue resolution
Audit responses
Study closeout
Inspection Readiness
Review Informed Consent Forms (ICFs)
ACCOUNTABLE FOR SAFETY ACROSS THE STUDY

Ensures development of and adherence to Safety Review Plan (SRP). Consistent with SRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the Clinician (MD) may delegate these responsibilities to the study clinical scientist identified in the SRP. The specific components of safety data review are detailed in the Safety Data Review Guide - for Clinicians and in SAF09 SOP.
Review individual subject data (including AEs and other safety data), SAEs, and potentially clinically important findings as well as determining if follow up is needed
Participate in Safety Review Team (SRT), interact with Data Monitoring Committee (DMC)
Provide responses to questions on safety: reviews literature as needed to respond to safety questions or those posed by the SRT, DMC or other individuals or bodies involved with the study
STUDY LEVEL DATA REVIEW

Perform review of data generated by statistical analyses
Request additional tables or analyses as indicated
Perform reviews and procedures required for database finalization
Authors Clinical Study Reports
Authors clinical sections of regulatory documents (e.g., Investigator Brochure (IB), IND Annual Reports)
ANSWER AND RESOLVE MEDICAL AND SAFETY QUESTIONS FROM SITES

General protocol questions, questions on inclusion/exclusion, etc.
Ensures answers are consistent across study regions
INTERACT WITH REGULATORY AUTHORITIES (RA) AND INTERNAL REGULATORY AND AUDITING GROUPS ON A STUDY LEVEL
Data Monitoring Committee
Support RA interaction, accountable for providing responses to RA inspection observations and internal audits
Support RA updates and registration submissions
CONTRIBUTE TO ORGANIZATION OF KEY STUDY REVIEW COMMITTEES AND SUPPORT THE FUNCTION OF THE COMMITTEE ACTIVITIES

Steering Committee
Clinical trial efficacy endpoint Adjudication Committee
PRESENTATIONS AND PUBLICATIONS OF CLINICAL TRIAL RESULTS

Under the direction of GCPL and/or CTL, prepare and deliver reports of clinical trial results to Pfizer committees as well as to regulatory authorities and external medical and scientific committees or conferences.
QUALIFICATIONS

MD degree
Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year), and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year.
M.D. required, internal medicine or surgical certification is highly desirable. Training and experience in infectious diseases or infection control experience in the hospital setting is preferred
Knowledge of Good Clinical Practice
Experience in small molecule or vaccine clinical development and conduct of clinical trials for treatement or prevention of diseases in hospitalized patients is prefered
Experience in assessment of adverse events and safety among hospitalized patients participating in therapeutic clinical trials is prefered
Skilled in protocol design, interpretation, and medical monitoring
General therapeutic area knowledge
Excellent written and oral communication
Capacity to adapt to a fast-pace and changing environment
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.

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.

Eligible for Relocation Package
Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.