Open Position for Senior Clinical Research Scientist
The following is a description of the tasks and responsibilities for the Senior Clinical Research Scientist position at Rebiotix Inc.
Reports to: Clinical Management
Summary of Position
The Senior Clinical Research Scientist is responsible for leading or supporting assigned study-level activities for one or more clinical studies (Phase 1-4) with minimal supervision. This position is responsible for development and/or review of clinical study documents, as well as data analysis, interpretation, and presentation. They work closely with the Associate/Director, Clinical Research to provide scientific support for clinical development planning, study design/execution, and data monitoring to ensure successful implementation of high-quality clinical research programs for Rebiotix products. The Senior Clinical Research Scientist is responsible for collaborating within and outside the Clinical Department, as well as with external resources to meet the business and product development goals of Rebiotix.
Primary Duties and Responsibilities
Responsible for preparation and scientific input to the execution of Phase 1-4 clinical studies:
- Provides input to the design and implementation of clinical development plans, as directed by Clinical Management.
- Designs, authors, and/or reviews clinical study protocols that are scientifically and statistically sound, align with the Rebiotix strategic plan, and meet regulatory requirements.
- Acts as the lead scientist for clinical studies, fielding protocol-related inquiries from study investigators and site staff, IRBs, institutional review committees, etc.
- Collaborates cross-functionally, working closely with Clinical Operations, Regulatory, Quality, and Marketing.
- Actively participates and/or presents at advisory boards and Investigator Meetings.
- Assists with Investigator-initiated research programs, as needed.
- Provides content development and editorial assistance for scientific publications, professional meetings, and/or post-marketing study activities, including abstracts, manuscripts and presentations.
Supports interpretation and presentation of clinical study data.
- Assists in the review of clinical data during study conduct and following database lock, as appropriate.
- Contributes to the preparation of key clinical documents, including but not limited to: clinical study reports, statistical analysis plans, FDA briefing documents, investigator brochures, informed consents, study plans and start-up materials, IND annual reports, clinical overviews and summaries, and clinical modules of IND, BLA, or NDA submissions to regulatory agencies.
Maintains clinical and therapeutic expertise in areas relevant to Rebiotix clinical research strategy.
- Establishes, maintains, and applies expertise in targeted therapeutic areas and reviews literature to evaluate new therapeutic areas and potential indications.
- Synthesizes literature and competitive information for study designs and results for assigned therapeutic areas.
- Maintains knowledge as to developments and trends in applicable treatment landscape, including current treatment strategies and new therapeutic developments.
- Develops valuable clinical collaborative relationships with key opinion leaders (KOLs) to support Clinical Research initiatives.
Supports Clinical Quality and compliance.
- Ensures all activities and deliverables meet current standards of ICH Good Clinical Practice, federal regulations and guidelines, industry standards, Rebiotix policies and standard operating procedures (SOPs).
- Supports internal and external quality audits and regulatory body audit preparation.
- Authors or contributes to SOPs supporting development and execution of clinical studies.
Any other duties as assigned for business reasons.
Required and Preferred Qualifications
- Required Bachelor’s degree in Life Sciences, Computer Sciences, Mathematics, or health-related field.
- Preferred MD, PharmD, or PhD
- Required 3 or more years of progressive clinical research experience in biotechnology or pharmaceutical industry.
- Required Strong interpersonal skills and ability to collaborate with and influence physicians, regulators, and stakeholders.
- Required Excellent verbal and written communication skills required. Interpersonal and organizational skills are a must.
- Required Detail-oriented with excellent writing, communication and presentation skills.
- Required Well versed and current in GCP, ICH, FDA and other relevant regulations and guidances that govern clinical study conduct.