Director, Medical Monitor (MD), VRD

$213,500 - $355,800/Yr

Pfizer - Pearl River, NY

Full-time - Mid Level

Pearl River, NY

Chemical Manufacturing

About the position

The clinician medical monitor is responsible for providing medical and scientific expertise for Clinical Trials, ensuring patient safety and overseeing the design, execution, monitoring, delivery, and reporting of clinical studies. This role involves developing strategies for obtaining worldwide approval for compounds, participating in committees, and aiding in new business development.

Responsibilities

• Accountable for safety across the study.
• Provide medical advice for all medical issues during risk assessment and mitigation planning.
• Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP).
• Perform and document regular review of individual subject safety data and cumulative safety data with the safety risk lead.
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports.
• Participate in the Safety Review Team to evaluate medical benefits/risks.
• Review literature to respond to safety questions posed by various teams.
• Communicate safety information to sites and respond to safety questions.
• Provide medical input during development and updates to the clinical development plan.
• Design clinical studies to meet stated objectives and ensure regulatory compliance.
• Support study team with clinical input for monitoring guidelines and data quality planning.
• Conduct medical review and interpretation of efficacy and safety data from clinical trials.
• Ensure the medical and scientific validity of study reports and disclosures.
• Provide protocol specific training to study team and investigators.
• Interact with healthcare professionals during the study to ensure compliance and safety.
• Support study team in issues resolution, study closeout, and audit responses.
• Author clinical sections of regulatory documents and may co-author publications.
• Interact with regulatory authorities and build a network of Key Opinion Leaders.

Requirements

• Medical degree (M.D./D.O. or equivalent).
• 4+ years' work experience in clinical research.
• Licensed by a health authority to prescribe medicines for at least one year.
• Ability to critically evaluate medical/scientific information.
• Excellent written and oral communication skills.
• Understanding of clinical program design and execution.
• Experience in the pharmaceutical industry related to clinical research programs.
• Ability to manage multiple studies and influence peers.

Nice-to-haves

• Documented work experience/knowledge of statistics.
• Training and experience in infectious diseases and/or infection control.
• Experience with investigational clinical trials.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage