Senior Clinical Scientist - Oncology - Home Based

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Scientist – Oncology – Home Based based in United States .** Take on a key scientific leadership role supporting the development and delivery of oncology clinical trials in a remote, sponsor-dedicated environment. You will contribute to clinical study design, protocol development, medical monitoring, and the interpretation of safety and clinical data. Working closely with cross-functional teams, medical writers, investigators, and external stakeholders, you will help ensure scientific rigor and high-quality trial execution. Your expertise will support critical decisions throughout the clinical development lifecycle, from study planning to database lock and results communication. You will also contribute to regulatory documentation, publications, and continuous improvements in trial quality. This opportunity combines scientific leadership, collaborative research, and the potential to make a meaningful difference in the development of treatments for patients worldwide. ### Accountabilities - Lead or support one or more oncology clinical studies, depending on study size and complexity, ensuring scientific integrity and appropriate execution of study protocols. - Serve as the primary clinical and scientific contact for internal and external stakeholders, addressing scientific questions and supporting interactions with investigators, study sites, and ethics committees or institutional review boards. - Contribute to clinical trial design and endpoint development in collaboration with clinical development leadership. - Lead medical monitoring activities, including developing Medical Monitoring Plans, reviewing serious adverse event (SAE) reports, and supporting safety assessments. - Establish and support Safety Advisory Committees, Data Monitoring Committees, adjudication committees, and other relevant study oversight groups. - Collaborate with medical writers on protocol development and amendments, participate in governance reviews, prepare protocol clarification letters, and contribute to study-specific documentation. - Review and update informed consent documents and provide scientific input into data management deliverables, including electronic data capture systems, data review plans, and case report forms. - Monitor clinical data issues requiring scientific input, review central laboratory reports and external data, and identify safety concerns or clinically significant values. - Prepare scientific presentations and slides, participate in investigator meetings, and communicate protocol requirements and scientific information to study teams. - Act as the scientific lead within the Clinical Trial Team (CTT), collaborating with study management, medical writing, and other functions to achieve study milestones. - Review study specifications, initiate randomization and allocation requests, and coordinate relevant approval schedules and allocation system requirements. - Coordinate laboratory requirements, biological specimen handling, and imaging specifications to ensure alignment with study protocols. - Contribute to study newsletters, database lock activities, Clinical Study Reports (CSRs), regulatory submission documents, and other clinical development deliverables. - Review and reconcile protocol deviation classifications, prepare deviation listings for clinical study reports, and support consistent documentation of study compliance. - Collaborate with medical writing teams on communicating trial results to investigators and support scientific publications and presentations as needed. - Provide scientific input for operational reviews, support interactions with external vendors, and supply clinical specifications for systems such as interactive voice response systems (IVRS) and electronic patient-reported outcomes (ePRO). - Mentor other Clinical Scientists and provide additional support to study management and medical writing teams to ensure timely, high-quality deliverables. ## Requirements - Educational background and clinical research experience: - Bachelor's degree in Life Sciences or a related discipline, with at least seven years of clinical research experience. - Alternatively, a Master's degree or PhD in Life Sciences, with at least five years of clinical research experience. - Candidates without a Life Sciences degree must have significant clinical development experience, typically exceeding 11 years. - At least two years of pharmaceutical or clinical drug development experience working as a lead Clinical Scientist. - Demonstrated experience in medical monitoring, including the review and assessment of clinical safety information. - Strong oncology clinical research experience and a solid understanding of oncology trials and their scientific requirements. - Excellent proficiency in Microsoft Excel and PowerPoint for data review, analysis, and scientific presentations. - Strong written and verbal communication skills, with the ability to present complex scientific information clearly to diverse audiences. - Ability to collaborate effectively with multidisciplinary teams, investigators, medical writers, study managers, and external stakeholders. - Strong analytical thinking, attention to detail, scientific judgment, and organizational skills. - Ability to manage multiple study deliverables and priorities while maintaining scientific quality and compliance. - Willingness and ability to travel up to 15% of the time, potentially including international travel. - Must be legally authorized to work in Canada for a Canada-based position and must not require current or future employer sponsorship for an employment visa. ## Benefits - Competitive compensation: Competitive base salary, with performance-related incentive opportunities. - Health coverage: Medical, dental, and vision benefits, where applicable. - Retirement benefits: Access to retirement savings and pension plans, depending on location and eligibility. - Financial protection: Life assurance and disability coverage. - Employee well-being: Employee assistance programmes and resources supporting personal and professional well-being. - Professional development: Structured training, ongoing learning opportunities, and career development pathways. - Remote work arrangement: Home-based work for eligible candidates in Canada. - Collaborative environment: Opportunity to work with multidisciplinary clinical research professionals in a sponsor-dedicated model. - Meaningful scientific impact: Contribute to oncology clinical trials and the development of treatments that may improve patient outcomes worldwide.