Job Description

Job Description

The Medical Director / Medical Monitor provides medical and scientific oversight across clinical trials and post-marketing activities to ensure compliance with company SOPs, client requirements, Good Clinical Practice (GCP), and global regulatory standards. This role serves as the primary medical authority for assigned programs, delivering expert medical consultation to clients, investigators, and internal project teams throughout the pharmaceutical product lifecycle. The position supports clinical development, pharmacovigilance, regulatory submissions, and business development activities, with a strong focus on neurology therapeutics.

Key Responsibilities

Medical Oversight & Leadership

• Provide end-to-end medical oversight for contracted clinical trial and pharmacovigilance activities across development and marketed products.
• Act as the medical authority for assigned projects, ensuring scientific integrity, patient safety, and regulatory compliance.
• Ensure all delegated pharmacovigilance and clinical activities are executed in accordance with applicable regulations, ICH guidelines, client SOPs, and internal company policies.
• Serve as a medical mentor and subject matter expert to cross-functional teams.

Clinical Trial Support

• Monitor all safety variables across clinical trials, including:
• Adverse events (AEs) and serious adverse events (SAEs)
• Laboratory abnormalities
• Changes in patient medical status
• Concomitant medications and protocol compliance
• Unblinding requests
• Provide medical review and assessment of:
• SAEs, AESIs, and clinical outcome events
• Safety narratives and case evaluations
• Discuss and resolve medical concerns with principal investigators and sponsors, including interpretation of inclusion/exclusion criteria and protocol deviations.
• Apply sound medical judgment to clinical decision-making related to investigational products.
• Perform ongoing data review per contract and Data Validation Plans, including coding listings and full safety datasets, to identify potential safety signals.

Pharmacovigilance & Marketed Product Support

• Medically review adverse event data from all sources (solicited, spontaneous, literature, and post-marketing programs).
• Lead and contribute to:
• Signal detection and evaluation activities
• Aggregate safety assessments
• Risk management activities (RMP, REMS)
• Scientifically review and approve periodic safety reports, including:
• PSUR / PBRER
• DSUR
• Support labeling updates, dossier maintenance, and ongoing benefit-risk evaluations.

Medical Writing & Regulatory Contributions

• Provide medical review and/or authoring support for:
• Clinical Study Reports (CSR)
• IND/NDA safety sections
• Individual Case Safety Reports (ICSRs)
• Signal detection reports
• CTD modules
• Labeling reconciliation documents
• Ensure medical accuracy, completeness, and regulatory compliance of all deliverables.
• Collaborate with biostatistics, data management, and regulatory teams on integrated safety analyses.

Training, Communication & Client Interaction

• Deliver therapeutic area and protocol training to internal teams and external stakeholders as requested.
• Attend and present at investigator meetings, sponsor meetings, and client teleconferences.
• Provide clear, timely, and effective medical consultation to clients, investigators, and project teams.
• Maintain open and proactive communication to ensure alignment with study objectives and regulatory expectations.

Business Development Support

• Support business development activities by providing medical expertise for proposals, bid defenses, and client discussions.
• Contribute to feasibility assessments and strategic planning from a medical and safety perspective.

Education & Experience

• MD with Board Certification in Neurology.
• Minimum experience meeting one or more of the following:
• ≥2 years of clinical experience treating patients within neurology or a related subspecialty
• 1–2 years of clinical trial experience within a CRO, pharmaceutical company, or as a principal investigator
• ≥2 years of direct experience in Pharmacovigilance or drug safety
• Equivalent combinations of education, training, and relevant experience may be considered.

Knowledge, Skills & Competencies

• Deep therapeutic expertise in Neurology
• Strong analytical, problem-solving, and decision-making abilities
• Excellent written and verbal communication skills
• Working knowledge of safety databases and terminology (e.g., MedDRA)
• Solid understanding of FDA, EMA, ICH, and GCP guidelines
• Familiarity with biostatistics, data management, and clinical operations
• High attention to detail and ability to manage complex, sensitive data independently
• Strong interpersonal, influencing, and team-building skills
• Proficiency in standard computer applications
• Ability to mentor and train junior staff
• Fluency in written and spoken English

Working Conditions

• Schedule: Monday–Friday, 7:00 AM – 4:00 PM EST
• Location: East Coast–based (time-zone requirement)
• Travel: Up to 10% (domestic US and occasional EU travel)
• Previous pharmaceutical or CRO industry experience strongly preferred

Job Tags

Similar Jobs