Clinical Medical Director / Medical Monitor

Position Overview

We are seeking an experienced Clinical Medical Director / Medical Monitor to support a biotechnology client's global clinical development programs. The primary focus of this role will be providing medical oversight for active Phase II and Phase III clinical studies, including data review, protocol support, investigator interactions, and strategic clinical guidance. The Medical Director will oversee multiple global clinical trials and serve as a key clinical expert within the development organization. The ideal candidate will possess significant sponsor-side Clinical Development experience and a strong understanding of global clinical trial execution. Important: Candidates with backgrounds exclusively in Medical Affairs or Drug Safety/Pharmacovigilance will not be considered.

Clinical Development & Strategy

• Assess clinical feasibility and clinical development strategies for assigned programs and studies
• Serve as the internal clinical expert for study execution and development planning
• Provide strategic clinical guidance across multiple development programs
• Support asset evaluations and business development due diligence activities

Medical Monitoring

• Review patient safety data and study endpoints
• Provide ongoing medical monitoring support for active clinical trials
• Respond to protocol and eligibility questions from investigators and study teams
• Assist in reviewing adverse events, serious adverse events, and medical narratives
• Participate in Safety Review Committee and Data Monitoring Committee activities as required

Study Design & Execution

• Develop and review: protocols, protocol amendments, Investigator Brochures, Case Report Forms (CRFs), Informed Consent Forms (ICFs), study manuals, and clinical documents
• Support study start-up, enrollment, conduct, and closeout activities
• Troubleshoot protocol and operational challenges during study execution

Investigator & External Interactions

• Serve as a primary medical contact for investigators and study personnel
• Lead investigator meetings and advisory boards
• Collaborate with key opinion leaders and clinical experts
• Provide medical responses to IRBs, investigators, and health authorities

Data Analysis & Reporting

• Partner with Biostatistics teams to review and interpret clinical data
• Author and review: Clinical Study Reports (CSRs), medical reports, regulatory documents, scientific publications, abstracts and presentations, white papers, and literature reviews

Regulatory Support

• Participate in FDA and other global regulatory authority interactions
• Author clinical sections of regulatory submissions
• Develop briefing packages and presentation materials
• Contribute to Clinical Development Plans and Target Product Profiles

Cross-Functional Leadership

• Work closely with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, and Project Management teams
• Present clinical updates and development strategies to internal and external stakeholders
• Ensure key development milestones remain on track

Required Qualifications

• MD required - Board Certified
• 7-10+ years of sponsor-side Clinical Development experience
• Experience serving as a Medical Director and/or Medical Monitor for clinical trials
• Extensive Phase II and Phase III clinical trial experience
• Experience overseeing multiple global studies simultaneously
• Strong protocol development and clinical document authorship experience
• Experience with: Investigator Brochures, Clinical Study Reports, Regulatory submissions, Clinical Development Plans
• Expertise in GCP, ICH guidelines, and global regulatory requirements
• Experience interacting with FDA and other health authorities
• Excellent communication, leadership, and cross-functional collaboration skills

Preferred Qualifications

• Rare Disease experience
• Cardiac surgery clinical research experience
• Hemostasis, bleeding disorders, blood products, transfusion medicine, critical care, cardiovascular, or perioperative medicine experience
• Global clinical trial leadership experience
• Biotech or pharmaceutical sponsor experience
• Participation in FDA, EMA, or international regulatory agency meetings