Clinical Scientist 2305-5828

This is a clinical-stage biotechnology company that places special emphasis on high-mortality cancers.

Territory: New Jersey/New York
Therapeutic Area: Oncology

The Clinical Scientist’s role is as a lead on the clinical trial team and medical monitoring team. This is a collaborative role working cross-functionally in developing, reviewing, and interpreting clinical data/medical protocol deviations, and related study materials.

Essential Duties and Responsibilities

• Ensures CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
• Collaborates to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
• Completes safety and efficacy data analysis to identify safety signals as well as identify different patient populations that can drive in patients’ benefit.
• Reviews periodic study reports for outliers, ranges, and potentially problematic data; identifies and communicates root causes and suggests possible solutions, documents data observations, and follows pre-established processes and procedures.
• Oversees different disease and treatments landscapes amongst the oncology field to identify and select areas for clinical development.
• Maintains availability to the sites and project team, including the Sponsor to ensure that medical questions or medical aspects of project-related questions are answered or communicated for resolution.
• Develops/updates the Medical Monitoring Plan (MMP), circulating it for approval within the company and with Sponsor.
• Reviews project specific plans, including the Safety Management Plan (SMP).
• Supports protocol development, revisions, submission, and approval, including collaboration with study steering committee and principal investigators and communication with the FDA.
• Reviews medical literature in the scope of preparation for project-related documents and provides input for preparation of the respective documents.
• Trains CRAs and other team members on different topics, including medical and/or safety aspects of the project or therapeutic area/indication.
• May provide medical review of study data, as per the MMP/Medical data review plan, for clarifying and resolving data inconsistencies, query management, trend assessment, etc.
• May review requests from Regulatory Authorities and/or Ethic Committees/IRBs and related activities with preparation of responses, when requested.
• Works closely with other functional groups and departments, including but not limited to Safety/Pharmacovigilance, Project Management, Clinical Operations, Data Management, Biostatistics and QA to ensure that medical operational functions are executed effectively as per contract.
• Supports the production of trial-related interim analyses, hypothesis testing, publications, and presentations.

Qualifications (Education & Experience)

• Advanced degree in science or engineering; PhD or MD preferred, Physician Assistant, Nurse Practitioner (NP), Advanced Registered Nurse Practitioner (ARNP), or Advanced Practice Registered Nurse (APRN) — in Oncology.
• Minimum of 3 years of direct oncology experience.
• Research experience post-training, including but not limited to CRO, Pharma, or Biotech.
• Prior experience across the spectrum of Medical Monitoring activities, including Medical review of safety information.
• Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH).
• Prior experience in development and delivery of therapeutic area/ protocol-specific training and presentations.
• Strong understanding of biostatistics.