Senior Clinical Scientist

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

📋 Description

• May lead or assist in a study or multiple studies, depending on their size and complexity.

• If in a leading role, responsible for the clinical and scientific execution of the protocol.

• Act as the primary clinical contact for scientific inquiries and issues for both internal and external stakeholders.

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

• Lead the Medical Monitoring team, which includes developing the Medical Monitoring Plan and reviewing Serious Adverse Event (SAE) reports.

• Establish and support Safety Advisory Committees (SAC), Data Monitoring Committees (DMC), and adjudication committees.

• Collaborate on protocols and amendments, participating actively in governance committee reviews.

• Write protocol clarification letters.

• Contribute to documents specific to the study.

• Review and update informed consent forms.

• Provide scientific input to data management tasks.

• Monitor data issues that require clinical insights.

• Oversee central lab reports and other external data for safety and critical values.

• Prepare scientific presentations and present protocol information at Investigator Meetings.

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

• Review specifications and initiate requests and approval timelines for allocations.

• Coordinate the planning of laboratory, biospecimen, and imaging specifications.

• Co-author newsletters alongside the Study Manager.

• Engage in database lock activities.

• Collaboratively plan Clinical Study Reports (CSRs) and Clinical Trial Documents (CTDs)/Wellness Management Activities (WMAs) with medical writing teams.

• Support publications and presentations as necessary.

• Reconcile and review classifications of protocol deviations in the Clinical Trial Management System (CTMS).

• Evaluate and prepare lists of protocol deviations for inclusion in CSRs.

• Work together with medical writing on communications related to trial results for investigators.

• Provide scientific evaluations for Operational Reviews.

• Assist the Study Manager and Medical Writer as needed to meet Clinical Trial Team (CTT) deliverables.

• Offer clinical specifications to the Study Manager for engagements with external vendors.

• May mentor other Clinical Scientists.

⛳️ Requirements

• Bachelor's or Master's degree in Life Sciences with over 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, must possess substantial experience in clinical development (over 11 years).

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

• Experience in medical monitoring is essential.

• Oncology experience is mandatory.

• Proficiency in Excel and PowerPoint is required.

• Exceptional written and verbal communication skills are necessary.

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

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

• Must not currently require, nor will require in the future, sponsorship for employment visa status.

• Employment with ICON is conditional upon possessing the legal right to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

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