About the Role
Provide expert medical guidance during clinical development programs, focusing on trial design, safety monitoring, and data interpretation for gastrointestinal therapies.
Responsibilities
- Oversee clinical trial protocols to ensure medical accuracy and regulatory compliance
- Evaluate patient safety data and advise on risk mitigation strategies
- Collaborate with cross-functional teams to interpret clinical findings
- Support the development of study documentation including protocols and informed consent forms
- Serve as medical liaison during regulatory interactions
- Review adverse event reports and assess medical significance
- Ensure alignment of trial conduct with current standards of care
- Advise on patient recruitment strategies and eligibility criteria
- Contribute to medical monitoring plans and oversight procedures
- Participate in investigator meetings and training sessions
- Guide medical aspects of trial amendments and protocol deviations
- Assist in the preparation of clinical study reports
- Provide input on drug safety profiles and benefit-risk assessments
- Monitor emerging scientific data relevant to gastrointestinal diseases
- Support due diligence for new development programs
- Review clinical data for medical trends and signal detection
- Collaborate with biostatistics and data management teams
- Ensure timely resolution of medical queries from investigative sites
- Maintain up-to-date knowledge of regulatory requirements in clinical research
- Contribute to internal medical review boards and safety committees
Nice to Have
- Prior experience as a therapeutic expert in late-phase trials
- Involvement in multicenter international studies
- Familiarity with centralized monitoring techniques
- Experience with adaptive trial designs
- Knowledge of gastrointestinal biomarkers and endpoints
Compensation
Competitive salary and benefits package
Work Arrangement
Remote with potential for on-site collaboration
Team
Global clinical research team within a contract research organization
Therapeutic Focus
Specialized in gastrointestinal disorders including inflammatory bowel disease, irritable bowel syndrome, and gastrointestinal cancers
Regulatory Environment
Must understand Health Canada and international regulatory expectations for clinical trial conduct and reporting
Not applicable
