Senior Clinical Scientist

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

📋 Description

• May lead or assist with one or more studies based on their size and complexity.

• Responsible for the clinical/scientific implementation of the protocol when acting as the lead.

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

• Assist in trial design and endpoint formulation in partnership with Clinical Development.

• Oversee Medical Monitoring activities, including the formulation of the Medical Monitoring Plan and review of SAE reports.

• Establish and support SAC, DMC, and adjudication committees.

• Collaborate on protocols and amendments and engage in governance committee reviews.

• Draft protocol clarification letters and contribute to documents specific to the study.

• Review and revise informed consent materials.

• Provide scientific insights for data management tasks and monitor clinical data discrepancies.

• Supervise central laboratory reports and other external safety data.

• Create scientific slides and present protocol details at Investigator Meetings.

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

• Coordinate specifications for laboratories, biospecimens, and imaging.

• Engage in database lock activities.

• Collaboratively strategize CSRs and CTDs/WMAs with medical writing.

• Assist with publications and presentations as necessary.

• Reconcile and assess protocol deviation classifications in CTMS.

• Prepare protocol deviation inventories for CSR.

• Collaborate on communicating trial results to investigators.

• Provide scientific evaluations for operational reviews.

• Support the Study Manager and Medical Writer in achieving the deliverables of the Clinical Trial Team.

• Offer clinical specifications for interactions with external vendors.

• May mentor other Clinical Scientists.

⛳️ Requirements

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

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

• If lacking a degree in Life Sciences, substantial experience in clinical development (greater than 11 years) is required.

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

• Medical monitoring experience is a must.

• Experience in oncology is required.

• Proficiency in Excel and PowerPoint is required.

• Strong written and verbal communication skills are necessary.

• Willingness to travel up to 15% (potentially including 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.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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