Medical Director/Medical Monitoring- Neurology

Work Schedule Monday to Friday Standard working hours: 7:00 AM – 4:00 PM EST Candidate should preferably be located on the U.S. East Coast for operational alignment with sponsors and global teams. Travel requirement: up to 10% (domestic U.S. and occasional Europe travel) Position Overview The Medical Director / Medical Monitor provides scientific and medical oversight across clinical development and post-marketing safety activities for neurological products. The role ensures that all clinical trial and pharmacovigilance activities comply with: Sponsor requirements ICH-GCP guidelines FDA and EMA regulations Internal SOPs and working procedures The physician acts as the primary medical expert supporting: Clinical trial safety monitoring Medical review of adverse events Signal detection and risk management Aggregate safety reporting Regulatory documentation Sponsor and investigator interactions This role combines: Clinical expertise in Neurology Clinical research oversight Pharmacovigilance leadership Regulatory medical writing support Cross-functional collaboration Key Responsibilities 1. Clinical Trial Medical Oversight Safety Monitoring Conduct ongoing medical monitoring for assigned clinical studies. Review: Adverse Events (AEs) Serious Adverse Events (SAEs) Adverse Events of Special Interest (AESIs) Laboratory abnormalities Clinical outcome events Concomitant medications Protocol deviations affecting patient safety Medical Review Activities Assess causality, severity, expectedness, and clinical significance of safety events. Evaluate eligibility concerns related to: Inclusion/exclusion criteria Protocol compliance Subject continuation/discontinuation decisions Participate in unblinding decisions when medically justified. Investigator & Sponsor Support Serve as medical contact for investigators and sponsors. Provide clarification on protocol-related medical questions. Participate in: Investigator Meetings Sponsor Governance Meetings Safety Review Committees Data Monitoring Committee interactions Clinical Data Review Review safety listings and coding outputs. Validate MedDRA coding consistency. Identify emerging safety trends or protocol risks. Collaborate with: Clinical Operations Data Management Biostatistics Regulatory Affairs 2. Pharmacovigilance & Drug Safety Responsibilities Case Processing Oversight Perform medical review of: Individual Case Safety Reports (ICSRs) Serious adverse events from clinical trials Spontaneous post-marketing reports Literature safety cases Solicited safety reports Aggregate Safety Reporting Contribute to and medically review: PSURs (Periodic Safety Update Reports) PBRERs (Periodic Benefit-Risk Evaluation Reports) DSURs (Development Safety Update Reports) Signal detection reports Benefit-risk assessments Signal Detection & Risk Management Participate in signal detection and evaluation activities. Support: Risk Management Plans (RMPs) REMS documentation Labeling updates Safety surveillance strategies Benefit-risk evaluations Regulatory Support Assist in preparation and review of: IND/NDA submissions CTD safety modules Clinical Study Reports (CSRs) Investigator Brochures Safety narratives 3. Medical Writing & Scientific Contributions Interpret clinical efficacy and safety data. Review scientific accuracy of: CSRs Safety summaries Regulatory documents Publications and presentations Support preparation of medical responses for health authorities. 4. Cross-Functional Collaboration Work closely with: Pharmacovigilance teams Clinical operations Regulatory affairs Biostatistics Medical writing Quality assurance Sponsors and CRO leadership Provide: Medical guidance Safety consultation Therapeutic expertise Training and mentorship 5. Training & Leadership Conduct protocol and therapeutic-area training. Mentor junior physicians and PV staff. Support process improvements and SOP development. Participate in inspection/audit readiness activities. Required Qualifications Education MD or equivalent medical degree Board Certification in Neurology required Experience Candidates should have one or more of the following: ~2 years of direct neurological clinical practice experience 1–2 years of clinical trial/CRO/pharmaceutical industry experience ~2 years of pharmacovigilance or drug safety experience Industry experience in: CROs Biotech Pharmaceutical companies is strongly preferred. Required Technical Knowledge Regulatory & Clinical Knowledge Strong understanding of: FDA regulations EMA guidelines ICH-GCP Pharmacovigilance regulations Clinical trial safety oversight Safety & PV Expertise Experience with: SAE review Signal detection Aggregate reports Risk management Benefit-risk analysis MedDRA coding terminology Clinical Development Knowledge Working understanding of: Biostatistics Clinical operations Data management Regulatory submissions Core Competencies Medical & Scientific Skills Deep therapeutic expertise in Neurology Strong analytical and clinical judgment Ability to interpret complex safety data Communication Skills Excellent verbal and written communication Ability to present to investigators and sponsors Strong stakeholder management skills Organizational Skills Ability to prioritize multiple studies/projects Detail-oriented with strong documentation practices Ability to work independently in a global matrix environment Leadership Skills Mentoring and coaching abilities Cross-functional collaboration Influencing without direct authority Typical Day-to-Day Activities A normal day may include: Reviewing SAEs and medical queries Attending sponsor safety meetings Discussing protocol issues with investigators Reviewing safety listings and signal outputs Contributing to aggregate safety reports Advising clinical operations teams Preparing medical input for regulatory submissions Conducting therapeutic training sessions