Clinical Development Scientist, Cell Therapy (Director/Senior Director, Doe)

Full Time On-Site/Hybrid Scientist Clinical Development Cell Therapy Apply for this Job 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: Hybrid (10-25% travel to Natick office, Clinical Sites, Conferences and Meetings, as required)

CLINICAL DEVELOPMENT SCIENTIST, CELL THERAPY (DIRECTOR/SENIOR DIRECTOR, DOE)

Responsibilities:

• Clinical Trial Support (60%)
• Clinical Synospis, Protocol and ICF development process including template creation, authoring, reviewing, adjudication and resolution of cross functional comments, in collaboration with Medical Writer
• Serve as drug product, protocol, and project subject matter expert for all stakeholders.
• Support pharmacovigilance activities (e.g. contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings)
• Supports and guides the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites). This could also include support for Case Report Form (CRF) development, and implementation of data capture tools.
• Work to improve the quality of reviews/ insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
• Provide guidance on clinical protocol, procedures, and the development of eCRF design and study plans
• Clinical Site facing activities: 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; develop and review clinical narratives; and monitor clinical data for specific trends.
• Liaise with clinical monitors to understand any trends on data management issues and work to develop solutions.
• Review / query clinical trial data – monitor data quality for trends, and ensure appropriate quality measures are in place; provide trends and escalate questions to Medical Monitor
• 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%)
• Contribute to clinical study and program timelines, review study feasibility, perform risk assessments and identify and execute mitigation and contingency planning efforts, with Program Management and Clinical Operations functions.
• Maintain understanding of CAR T and other cell therapy competitors and clinical developments in relevant therapeutic areas by attending scientific meetings, maintaining relationships with KOLs, and tracking literature.
• Support execution of Safety Review Committee, Data Safety Review Board and clinical advisory board meetings, including scheduling, agenda and presentation development and socializing of pre-reads to all attendees.
• Serve as a clinical science lead on study team meetings 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 Statistical Analysis Plans, IND and Orphan Annual Reports, Investigators’ Brochure, IRB responses, CSRs 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, andresponses.

Qualifications:

• Advanced degree in Life Sciences (MS with 9+ years of experience or MD, PhD or PharmD with 6+ years of experience) preferred. Prior cell therapy and/or immuno-oncology experience a plus.
• 3+ years as a Clinical Scientist or comparable role in Clinical Development, minimum 2 years Sponsor experience.
• 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.
• Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
• 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.
• 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.