Senior Clinical Scientist – Oncology

Role Overview

• May lead or support a study or studies, depending on size/complexity.
• Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)
• Responsible for trial design and endpoint development in collaboration with CD
• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports
• Sets up/supports SAC, DMC, adjudication committees
• Collaborates with medical writer, participates in governance committee review
• Reviews/updates informed consent
• Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)
• Monitors data issues requiring clinical input
• Prepares scientific slides, attends and presents protocol information at Investigator Meeting
• Scientific lead on Clinical Trial Team (CTT)
• Coordinates planning of lab, bio specimens and imaging specifications
• Co-authors newsletters with SM
• Participates in Database lock activities
• Collaboratively plans CSRs, CTDs/WMAs with medical writing
• Supports publications/presentations as needed
• Reconciles and review all protocol deviation classifications in SPECTRUM
• Assesses and prepares protocol deviation list for CSR
• Collaborates with medical writing to develop trial results communication for investigators
• Provides scientific assessment for Operational Reviews
• Supports SM/MW activities as needed to achieve CTT deliverables.
• Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)
• May act as mentor to other CSs

Requirements

• BS/BA in Life Sciences with 7+ yrs clinical research experience
• MS/PhD in Life Sciences with 5+ years clinical research experience
• If no degree in Life Sciences, must have significant experience in clinical development (>11 years)
• Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead CS required.
• Medical monitoring experience required
• Oncology experience required
• Excellent Excel and PP skills required
• Excellent written and oral communication skills
• Ability to travel up to 15% (might include international travel)
• Applicants must be legally authorized to work in the Canada or US, and should not require, now or in the future, sponsorship for employment visa status.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.