Senior Clinical Scientist – Oncology

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Lead or assist with studies based on their size and complexity.

• Act as the clinical point of contact for scientific inquiries and concerns from both internal and external stakeholders.

• Oversee trial design and endpoint development in partnership with the Clinical Director.

• Manage the Medical Monitoring team, which includes the creation of the Medical Monitoring Plan and the review of SAE reports.

• Establish and support the setup of SAC, DMC, and adjudication committees.

• Collaborate on protocols and amendments, and take part in governance committee reviews.

• Draft protocol clarification letters and assist in the creation of study-specific documents.

• Review and revise informed consent materials.

• Offer scientific input to study management regarding data management tasks.

• Monitor data discrepancies, central laboratory reports, and external safety data.

• Create scientific presentations and deliver protocol information at Investigator Meetings.

• Function as the scientific lead on the Clinical Trial Team.

• Review specifications and initiate requests for allocation and randomization.

• Coordinate specifications related to laboratory, biospecimens, and imaging.

• Co-author newsletters and engage in database lock activities.

• Collaboratively develop CSRs and CTDs/WMAs in conjunction with medical writing.

• Assist with publications and presentations.

• Reconcile and assess protocol deviation classifications, and prepare protocol deviation lists for CSRs.

• Work with medical writing on communications regarding trial results.

• Provide scientific evaluations for Operational Reviews.

• Support study management and medical writing efforts to meet Clinical Trial Team goals.

• Provide clinical specifications for interactions with external vendors.

• Mentor other Clinical Scientists as necessary.

⛳️ Requirements

• BS/BA in Life Sciences with 7+ years of clinical research experience.

• MS/PhD in Life Sciences with 5+ years of clinical research experience.

• If lacking a degree in Life Sciences, must have substantial experience in clinical development (over 11 years).

• At least 2 years of experience as a lead Clinical Scientist in pharmaceutical and/or clinical drug development is required.

• Experience in medical monitoring is essential.

• Oncology experience is a must.

• Proficiency in Excel and PowerPoint is necessary.

• Strong written and verbal communication skills are required.

• Willingness to travel up to 15% (including possible international travel).

• Must be legally authorized to work in Canada or the US.

• Must not require current or future sponsorship for employment visa status.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Comprehensive health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.