Associate Director, Medical Monitor VRD
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.
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 conjunction with GCPL and Pfizer colleagues, organizing expert panels or consultant or advisory board meetings to provide 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 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.
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.
· 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 treatment or prevention of diseases in hospitalized patients is preferred
· Experience in assessment of adverse events and safety among hospitalized patients participating in therapeutic clinical trials is preferred
· Skilled in protocol design, interpretation, and medical monitoring
· General therapeutic area knowledge
· Excellent written and oral communication
· Capacity to adapt to a fast-paced and changing environment
· Some travel may be required for the position
Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus