Senior Director, Biomarker and Cdx

Full Time On-Site/Hybrid Medical Affairs Director Biomarker CDx 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 Senior Director, Biomarker and CDx to help advance the use of CAR T therapy for solid tumors. As part of the clinical development team, you will play a primary role in the crafting and operationalization of Affy’s biomarker and companion diagnostic strategy.

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 regulatory expertise, organization, and enthusiasm, you will leave an indelible mark on Affy.

Location: Hybrid (2 days per week in Natick, Mass. HQ)

SENIOR DIRECTOR, BIOMARKER AND CDX

Responsibilities:

• Clinical Biomarker Strategy and Operations (65%)
• Lead the clinical biomarker function to develop and deliver the biomarker strategy for AffyImmune’s clinical programs.
• Build and maintain fit for purpose biomarker plan for all clinical stage programs.
• Design, execute, and analyze clinical biomarkers of target engagement, safety, pharmacodynamics, and efficacy.
• Lead generation of key clinical assay reagents, such as positive controls for immunogenicity assays, as well oversee development and validation of the following key clinical protocol called out clinical assays, such as immunogenicity assays (Anti-drug antibody assays), Flow cytometry based immunophenotyping assays, ddPCR based vector copy number assays (VCN), multiplexed IHC in tumor FFPE tissues, and exploratory biomarkers, among others
• Manage outsourced biomarkers assays at external vendors to ensure delivery of high-quality data.
• Provide oversight of clinical biomarker vendors, including development and tech transfer of assays, and validation and clinical readiness.
• Coordinate between CRO/vendor assay development group and clinical team, when necessary.
• Ensure compliance of Context of Use (COU) clinical biomarkers with clinical trial registration requirements.
• Partner closely with AffyImmune’s Clinical Operations team to provide technical oversight and troubleshooting of clinical sample analysis, as well as clinical sample collection and processing expertise.
• Companion Diagnostic Support (20%)
• Support development of IHC based trial eligibility and CDx assays for clinical trial programs at qualified vendors, working in conjunction with regulatory and clinical development functions.
• Maintain functional awareness of regulatory, compliance, and relevant guidelines and Agency Guidance for CDx development and commercialization.
• Operational Support (15%)
• Contribute to the development of clinical trial documents, e.g., study protocol, informed consents, CRF, monitoring plan/conventions, tracking forms and other study-related documents.
• Internal lead for biomarkers and companion diagnostic at study team meetings.
• Oversee clinical biomarker sample operations in collaboration with Clinical Operations team.
• Author relevant sections of clinical and regulatory documents.
• Perform other duties as assigned.

Qualifications:

• PhD + 8 or MS + 12 years of biotech experience; prior oncology or cell and gene therapy sector-experience required. Experience authoring and reviewing SOPs and validation documents to support regulatory filings.
• Proven track record of high-impact contributions to clinical trial biomarkers and endpoints, and regulated assay development and validation in support of early and late phase clinical trials.
• Experienced and well-versed with FDA Guidance related to immunogenicity assay development and validation, bioanalytical validation of clinical assays, and industry whitepapers for state-of-the-art method validation of clinical assays. This individual will apply FDA recommendations to validation and deployment of key primary, secondary and exploratory endpoint supporting clinical assays.
• Understanding of the regulatory and commercialization requirements for CDx.
• Experience with, at a minimum, immunohistochemistry, flow cytometry assays, molecular biology biomarker assays, and vector copy number (VCN) assays in a regulated setting.
• Outstanding written and oral communication skills for clinical, business, and scientific audiences.
• Strong sense of urgency and excellence in prioritization, planning, and execution in line with corporate and changing program goals
• Strong interpersonal skills and ability to thrive in a matrix environment with internal and external stakeholders.
• Highly adept at solving complex, cross-functional problems.
• Experience in managing external collaborations, contract laboratories, timelines, and budgets.
• 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.