AffyImmune Therapeutics (“Affy”), a clinical stage biotechnology company focused on developing technologies that expand the utility and improve the safety and efficacy of cell-based immunotherapy for cancer, is seeking a Clinical Scientist to help advance the use of CAR T therapy for solid tumors. As part of the clinical development team, you will provide the scientific expertise necessary to design and advance clinical studies and programs.

Reporting to the Senior Vice President of Clinical Development, you will join a small team at a dynamic startup. You will collaborate within and outside the company to help us advance our clinical development. With your scientific acumen, vision, and attention to detail, you will leave an indelible mark on Affy.

Location: Remote (This job posting does not apply to Colorado applicants.) with 10-25% travel required.

CLINICAL DEVELOPMENT SCIENTIST, CELL THERAPY/IMMUNO-ONCOLOGY (ASSOC. DIRECTOR/DIRECTOR, DOE)

Responsibilities:

Clinical Trial Support (60%)

• Assist in the development of site and CRA training materials and present at SIVs and Investigator meetings.
• Deliver quality study strategy and design, including analysis and interpretation of data throughout the study, including leading clinical data review with Data Management; reviewing clinical narratives; and monitoring clinical data for specific trends.
• Serve as product, protocol, and project subject matter expert to support internal and external customers.
• Provide guidance on protocol, procedures, and the development of eCRF design and study plans
• Liaise with monitors to understand any trends on data management issues and work to develop solutions. Participate in any CRA meetings.
• Review / query clinical trial data – monitor data quality and ensure appropriate quality measures are in place.
• Ensure consistency of study execution to facilitate data analysis and regulatory filing.
• Support study specific vendor interaction and coordination.
• Perform other duties as assigned.

Program Support (25%)

• Review study feasibility, perform risk assessments and identify and execute mitigation and contingency planning efforts, with Clinical Operations.
• Provide input on study/program timelines
• Maintain understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific meetings, maintaining relationships with KOLs, and tracking literature.
• Serve as a clinical science lead on immuno-oncology clinical studies and contribute to program-level activities.
• Review and enhance the technical and scientific robustness of program-level clinical development plans.
• Contribute to development of end-to-end clinical development strategy.

Regulatory Support (15%)

• Contribute to the development of clinical trial documents, e.g., study protocol, informed consents, CRF, Orphan Annual Reports, Investigators’ Brochure, IRB responses, and other study-related documents. Author relevant sections of clinical and regulatory documents.
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and Affy SOPs for all products and services delivered for designated studies.
• Support regulatory interactions, including through briefing documents, presentations, questions, and responses.

Qualifications:

• Advanced degree in Life Sciences (MS with 7+ years of experience or MD, PhD or PharmD with 4+ years of experience) preferred. Prior cell therapy and/or immuno-oncology experience a plus.
• Working knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations. GCP/ICH experience including writing and/or reviewing study protocols, procedures manuals, ICFs, and clinical study reports a plus.
• Ability to understand assigned clinical protocol(s), their requirements, and support program-specific data review and trend identification.
• Proven planning/project management skills
• Outstanding written and oral communication skills for clinical, business, and scientific audiences.
• Strong sense of urgency and excellence in prioritization, planning, and execution
• Strong interpersonal skills and ability to thrive in a matrix environment.
• Highly adept at solving complex, cross-functional problems.
• Demonstrated scientific capability as evidenced by publications, patents, research reports, or presentations.
• Effective verbal and written communication skills within and outside the company
• Flexibility to work on multiple projects as the portfolio evolves over time.
• Meticulous attention to detail, including capacity to conduct thorough self-reviews.
• Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
• Highly organized, collaborative, and motivated in a fast-paced startup environment.
• Comfort with Microsoft Office (PowerPoint, Excel, Word, OneDrive, Project, Visio).

This is a salaried, benefit-eligible position.