Summary: Under administrative direction, provides medical expertise to assist with clinical product development in the Company’s specific therapeutic focus areas.
The Medical Monitor will serve as the medical expert for assigned clinical trials. This role will provide input into the design and conduct of clinical trials, assessment and interpretation of safety data, and contribute to investigator training. Available as a remote position from a home-based office.
Essential Duties and Responsibilities
- Working with program leadership and team members to further the company’s clinical development program by assisting in the design and conduct of clinical trials including the drafting of protocols and amendments and contributing to related clinical documents.
- Be the Medical Expert (“Medical Monitor”) for assigned clinical trials which includes being readily available to advise on trial-related medical questions or problems during the conduct of the trial.
- Lead medical aspects of medical monitoring, including CRO oversight for medical monitoring activities as needed
- Identifies study challenges during the conduct of the study and works with relevant stakeholders to ascertain and implement solutions
- Contribute to investigator training.
- Contribute to responses regarding IRB/ethics committee queries
- Assist in medical data review, assessment and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation.
- Work closely with the other departments providing medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Company Core Safety Information (CCSI), Investigator Brochure (IB), Risk Management Plans, Integrated Summaries of Safety and Efficacy, Clinical Study Reports and preparation of labels.
- Collaborate with safety/pharmacovigilance to implement the safety monitoring plan
- Attendance at teleconferences and face-to-face meetings for study activities as needed.
- Responsible for implementing alignment across policies/procedures and ensure that data generated meet monitoring and compliance with FDA, ICH guidelines and GCP.
- Works with team members in a matrix environment with the ability to work on multiple, complex projects in parallel
- Medical degree with strong leadership skills including 5-10 years direct experience in the pharmaceutical industry preferably in a medical monitoring role.
- US and EU experience preferred.
- Experience in IBD preferred but all therapeutic areas will be considered.
- Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs.
- Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders.
- Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing.
- Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities
- Medical degree (M.D.) in a scientific/technical or related field from an accredited college or university, and six (6) years pharmaceutical/clinical experience, including four (4) years in a supervisory or management capacity or an equivalent combination of education and