Clinical Scientist interpreting WES/WGS data and classifying variants for SeqOne, a clinical genomics company. Supporting rare - disease diagnostics through regulated, patient - centered genomic reporting.
About the role
- Senior Clinical Scientist leading HIV clinical trials for ICON Strategic Solutions’ sponsor-dedicated research programs. Managing medical monitoring, protocol execution, data review, and investigator collaboration.
Responsibilities
- May lead or support one or more studies depending on size and complexity
- Accountable for clinical/scientific execution of the protocol when serving as lead
- Serve as clinical point of contact for scientific issues and questions for internal and external stakeholders
- Support trial design and endpoint development in collaboration with Clinical Development
- Lead Medical Monitoring activities, including Medical Monitoring Plan development and SAE report review
- Set up and support SAC, DMC, and adjudication committees
- Collaborate on protocols and amendments and participate in governance committee review
- Author protocol clarification letters and contribute to study-specific documents
- Review and update informed consent materials
- Provide scientific input for data management activities and monitor clinical data issues
- Monitor central laboratory reports and other external safety data
- Prepare scientific slides and present protocol information at Investigator Meetings
- Serve as scientific lead on the Clinical Trial Team
- Coordinate laboratory, biospecimen, and imaging specifications
- Participate in database lock activities
- Collaboratively plan CSRs and CTDs/WMAs with medical writing
- Support publications and presentations as needed
- Reconcile and review protocol deviation classifications in CTMS
- Prepare protocol deviation lists for CSR
- Collaborate on trial results communications for investigators
- Provide scientific assessment for operational reviews
- Support Study Manager and Medical Writer activities to achieve Clinical Trial Team deliverables
- Provide clinical specifications for interactions with external vendors
- May mentor other Clinical Scientists
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, 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)
- 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 and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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