Senior Clinical Scientist

This is a fully remote position, open to applicants in Canada, +1 more country.

📋 Description

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

• Ensure the clinical and scientific execution of protocols when acting as the study lead.

• Serve as the primary clinical contact for scientific inquiries from both internal and external stakeholders.

• Oversee trial design and endpoint development in collaboration with Clinical Development.

• Manage Medical Monitoring activities, including the creation of Medical Monitoring Plans and the review of SAE reports.

• Establish and support the Scientific Advisory Committee (SAC), Data Monitoring Committee (DMC), and adjudication committees.

• Collaborate on the development of protocols, amendments, governance reviews, and study-specific documents.

• Draft protocol clarification letters and review/update informed consent documents.

• Offer scientific input for data management and oversee clinically significant data issues.

• Supervise central laboratory and external safety data monitoring.

• Prepare and deliver protocol information at Investigator Meetings.

• Act as the scientific lead for the Clinical Trial Team.

• Coordinate specifications for randomization, laboratory, biospecimen, and imaging.

• Engage in database lock activities and collaboratively plan Clinical Study Reports (CSRs) and Clinical Trial Documents (CTDs)/Work Management Agreements (WMAs).

• Assist with publications and presentations.

• Review classifications of protocol deviations and compile deviation lists for CSRs.

• Collaborate on the communication of trial results with investigators.

• Provide scientific evaluations for operational reviews.

• Support study management and medical writing efforts to meet team objectives.

• Mentor other Clinical Scientists as necessary.

⛳️ Requirements

• Bachelor's or Master's degree in Life Sciences with a minimum of 7 years of clinical research experience.

• Master's or PhD in Life Sciences with at least 5 years of clinical research experience.

• If lacking a degree in Life Sciences, extensive experience in clinical development (over 11 years) is required.

• A minimum of 2 years of experience in pharmaceutical and/or clinical drug development as a lead Clinical Scientist is mandatory.

• Experience in medical monitoring is essential.

• Background in Infectious Disease is required.

• HIV experience is highly preferred.

• Proficiency in Excel and PowerPoint is required.

• Strong written and verbal communication skills are essential.

• Willingness to travel up to 15%, which may include international travel.

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

• Must not require, now or in the future, sponsorship for employment visa status.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs that include medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and resources for wellbeing.

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

• Reasonable accommodations will be provided during the recruitment process.