Job In Pharma – on behalf of an important client – is seeking a:
The Research Scientist (MD) will lead the development of oncology clinical protocols, oversee the execution of the clinical research studies, and ensure the compliance of department, company and regulatory standards and procedures across the assigned clinical development program. The successful person in this role will provide mentoring and guidance to the clinical research scientists on the team.
The Research Scientist (MD) will work closely with the clinical research scientists in the Medical Science Team, in collaboration with other functional disciplines, The Research Scientist will represent the Clinical Sciences team in internal governance and committee meetings relating to the overall clinical development strategy and operational implementation of the clinical studies in the clinical development plan. In addition, he/she will represent the company at external meetings including, but not limited to FDA/EMA interactions and other national regulatory agencies.
Essential Duties (at trial level)
1. Overseeing clinical trial set-up activities:
• Author, review, and approve the clinical trial protocol within the specified timelines.
• Review and approve the master Informed Consent Form (ICF), Statistical Analysis plan (SAP) within the specified timelines.
• Review and approve the Data Monitoring Committee (DMC or equivalent) charter.
• Provide compound, disease and Clinical Protocol related training, as applicable.
2. Managing clinical trial activities:
• Perform medical review and safety analysis of clinical trial subjects, ensure comprehensive medical monitoring
• Review and approve all the required listings prior to database lock.
• Communicate timely with the trial team of any change in scope, timelines, budget and quality affecting any of the trial coordination.
3. Managing Serious Adverse Event (SAE) reporting process:
• Detailed and timely review of the SAE Reports to verify the content and meet the expedited reporting timelines
• Coordinate answers to questions of Regulatory Authorities, IECs/IRBs and Investigators.
• Evaluate if new safety information requires an amendment to the clinical trial protocol and/or ICF for on-going clinical trials.
• Ensure that, if applicable, follow-up information on the SAE is collected.
4. Interaction with the medical community
• Ensure timely interaction with the clinicians, advocacy groups and other experts.