Under the supervision of the Vice President of Clinical Development and Medical Affairs, the Clinical Scientist drives and executes the goals for the study design, plan, protocol development, implementation and monitoring of the company’s Phase I/II Oncology/Hematology clinical trials. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the department and the company to regulatory standards and procedures.
• Assist in or design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents.
• Provide clinical input for clinical protocol monitoring guidelines and analysis plans.
• Drive clinical interpretation of study data. Track emerging efficacy and safety profile of drugs in on-going clinical trials; inform Clinical Development team of changes in the efficacy/safety and/or risk benefit profiles as they occur.
• Provide input and/or prepare clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, clinical supplies package diagrams and labeling).
• Lead or assist in the development of publications – abstracts, manuscripts, slides, etc.
• In collaboration with team members (e.g., Clinical Operations, Data Management), assist in identifying / evaluating / monitoring vendors, monitoring clinical trial conduct/status.
• Assist in database finalization, reviews of study results, results interpretation and CSR’s.
• Assist in planning and conduct of investigator meetings.
• Assist with field site questions during conduct of trials as needed.
• Coaching and mentoring less experienced Clinicians as assigned.
• Bachelor’s level degree or equivalent required (graduate level degree preferred) in a scientific or clinical discipline (Clinical Pharmacy, Nursing) Phase I–III clinical trial experience preferred.
• 4-8+ year’s clinical development experience in the pharmaceutical industry, oncology preferred, clinical pharmacology and hematology experience an asset.
• Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts.
• Working knowledge of the IND/NDA process
• In depth knowledge of GCP/ICH guidelines
• Strong written and verbal communication skills as well as proven ability to interact with different functional groups
• Good organizational, time management and interpersonal skills, proficiency in computer and software skills
• Available for some travel, including overnight stays.
• Experience with regulatory submissions is an asset.