Medical Officer

Roles & Responsibilities
• Act as Medical Monitor for assigned clinical trials, providing oversight of safety and efficacy data in compliance with SOPs and study documents
• Work closely with the Head of Pharmacovigilance and Medical Monitoring on corporate and project-level activities
• Provide safety oversight across the full clinical study lifecycle, including assessment of safety events and protocol deviations
• Evaluate adverse events, serious adverse events (SAEs), expedited reports, and other protocol-defined safety events
• Review SAE narratives, IND/IDE safety reports, CIOMS reports, DSURs, and other aggregate safety reports
• Review and approve MedDRA and WHO Drug coding
• Monitor regulatory safety communications (e.g., FDA MedWatch alerts) and recommend actions for study teams
• Provide medical input into protocol development with a focus on safety, inclusion/exclusion criteria, study design, and halting rules
• Ensure medical and scientific quality of safety sections in protocols, investigator brochures, informed consent forms, CRFs, and related documents
• Develop and support study documents including Safety Monitoring Plans, Medical Monitoring Plans, Communication Plans, and Training Plans
• Support preparation of safety sections for annual reports and clinical study reports
• Participate in safety oversight committees (DSMB/DMC/SMC), review charters and minutes, and address safety-related queries
• Engage with sponsors, investigators, regulatory authorities, and study partners as required
• Support bid preparation and bid defense meetings as a medical expert
• Deliver medical training to internal stakeholders and provide broad medical consultancy as contracted
• Contribute to corporate quality assurance, SOP development, internal audits, and continuous process improvement activities

Qualification
• Medical degree (MD / MBBS / MBBCh or equivalent)

Experience
• Minimum 2 years of professional experience
• Combination of clinical practice and pharmaceutical medicine experience (clinical research, pharmacovigilance, medical affairs, or regulatory) preferred
• Experience in safety or medical monitoring and SAE reporting preferred

Skills
• Strong clinical judgment and medical decision-making ability
• Expertise in safety evaluation and medical monitoring in clinical trials
• Understanding of regulatory submissions and clinical research processes
• Ability to communicate complex clinical issues clearly and scientifically
• Strong cross-functional collaboration and leadership skills
• Excellent written and verbal communication skills

About the Company
Emmes Group is a global clinical research organization with more than four decades of experience advancing medical discovery. Originally established as a key clinical research partner to the US government, Emmes has expanded into public-private partnerships and commercial biopharma, with leading capabilities in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.