Director, Clinical Scientist

Accountabilities Lead Clinical Study Design: Drive or contribute to the design, refinement, and amendment of oncology clinical studies in collaboration with internal teams and external scientific stakeholders. Develop Clinical and Regulatory Documentation: Partner with medical, regulatory, and cross-functional colleagues to author and review clinical protocols, protocol amendments, regulatory submissions, meeting packages, and other essential documentation. Oversee Clinical Data Quality: Collaborate with Clinical Operations, Data Management, and Contract Research Organizations (CROs) to establish and implement data quality plans, conduct internal medical data reviews, and identify emerging safety trends across assigned studies. Provide Clinical Scientific Guidance: Serve as a key contact for clinical inquiries from CRO medical monitors and other stakeholders, providing scientific insight and helping resolve study-related questions. Support Study Start-Up and Execution: Work with Clinical Operations and CRO partners to develop and maintain essential study resources, including informed consent forms, laboratory manuals, electronic data capture materials, and safety monitoring plans. Monitor Patient Safety: Participate in safety review meetings and track, analyze, and review documentation relating to potential safety events, supporting appropriate evaluation and follow-up. Drive Study Enrollment and Site Engagement: Build collaborative relationships with investigators, clinical site staff, CROs, and internal colleagues to support enrollment, address operational challenges, and facilitate effective study execution. Develop Scientific Communications: Lead or contribute to communication strategies for ongoing and completed studies, including key opinion leader (KOL) engagement, advisory boards, medical congresses, publications, and scientific meetings. Prepare Scientific Materials: Write and review abstracts, posters, presentations, meeting content, and other publicly distributed scientific materials, coordinating reviews and approvals with relevant internal stakeholders. Coordinate Scientific Submissions: Manage submissions to scientific meetings, conferences, and other appropriate venues, ensuring materials are accurate, timely, and aligned with study objectives. Interpret Clinical and Translational Data: Evaluate clinical findings alongside immunology and immuno-oncology translational data to inform study decisions, scientific communications, and broader development strategies. Anticipate and Resolve Study Challenges: Take a proactive approach to clinical study execution by identifying potential obstacles early, developing practical solutions, and supporting consistent delivery across clinical programs. Requirements: Education: Master's degree or equivalent required in a relevant scientific or healthcare discipline. A PhD, PharmD, or MD is preferred. Professional Experience: At least 5 years of relevant overall experience for candidates with a PhD or comparable advanced degree, including a minimum of 2 years conducting or supporting hematology or oncology clinical studies. Oncology Clinical Research Knowledge: Understanding of clinical trial design, study execution, clinical data interpretation, and the scientific and operational considerations involved in oncology drug development. Clinical and Regulatory Documentation: Experience authoring, reviewing, or contributing to clinical protocols, amendments, regulatory documentation, meeting packages, abstracts, posters, and scientific presentations. Data Interpretation Expertise: Ability to analyze clinical data and interpret immunology and immuno-oncology translational findings to support evidence-based decisions. Clinical Safety and Data Quality: Familiarity with clinical data review, safety monitoring, data quality processes, and collaboration with clinical operations and CRO teams. Scientific Communication: Excellent written and verbal communication skills, with the ability to translate complex scientific findings into clear, accurate, and compelling materials for varied audiences. Cross-Functional Collaboration: Demonstrated ability to work effectively with medical, regulatory, clinical operations, data management, translational research, and external partners. Stakeholder Management: Strong relationship-building skills and the ability to collaborate with investigators, clinical site personnel, medical monitors, and scientific experts. Strategic and Analytical Thinking: Strong scientific judgment, attention to detail, and the ability to identify challenges, synthesize complex information, and recommend practical solutions. Organization and Execution: Ability to manage multiple priorities, coordinate deliverables, and maintain high standards of scientific quality and accuracy in a fast-paced clinical development environment. Work Location: Must be able to work remotely from the United States. Benefits: Competitive Base Salary: Annual pay range of $192,000–$239,000 USD, with actual compensation determined by experience, skills, certifications, and work location. Additional Compensation: The total compensation package may include performance bonuses, stock or equity awards, and other applicable variable compensation. Potential Benefits Package: Eligibility for employee benefits, subject to the applicable company plan and terms. Remote Work: Opportunity to work remotely within the United States. Scientific Impact: Contribute to clinical development programs addressing significant unmet needs in oncology. Professional Growth: Collaborate with experienced clinical and scientific professionals across multidisciplinary, global development programs. Meaningful Mission: Help advance cancer research and the development of investigational therapies intended to improve patient outcomes and quality of life. Collaborative Environment: Work alongside clinical, regulatory, translational, and operational teams in a science-driven organization focused on scientific rigor, integrity, and purposeful execution. #J-18808-Ljbffr Jobgether