Director/Senior Director Translational Research (nonclincal)

I'm working with a pioneering East Coast-based company specializing in cell therapy, and they are looking for a Director or Senior Director of Translational Research to lead the development of cutting-edge therapies targeting immunology diseases.

The role focuses on improving validation in animal models and preparing protocols and documents for IND submission and a great opportunity to be part of a growing team driving innovation in immunology and regenerative medicine, reporting into the CSO.

Director/Sr. Director, Translational Research will be integral to developing effective models using preclinical data to assess strategic emphasis on creating best in class treatments.

Key Responsibilities:

• Oversee translational and nonclinical study strategy, design, and execution for the pipeline.
• Collaborate with cross-functional project teams for design, coordination, and execution of translational and nonclinical development strategies
• Develop clinical biomarker testing strategies and assays for clinical trials’ immunological endpoint assessments, collaborate with the clinical team on all aspects of clinical trial patient sample collections, and communicate translational designs and findings with clinical investigators
• Perform independent investigational research within the field of study to provide leadership to advance optimization of the translational and in vivo nonclinical methodologies, technologies, and industry trends.
• Develop and present Pharmacology, Biodistribution, Immunology, and Toxicology strategies, plans and data at project team meetings and to management to support project objectives.
• Perform hands-on work with immunological assays and animal models, as needed.
• Author, review and approve nonclinical protocols and deliver high-quality data packages and reports to support the filing of regulatory documents for IND (or related) submissions.
• Establish and maintain effective relationships with CROs and consultants for the design and execution of nonclinical studies.
• Provide leadership for translational and nonclinical project management and ensure all nonclinical programs are completed within established timelines.
• Prepare and present translational and nonclinical project updates to the Executive Team.
• Collaborate closely with finance and operations teams.
• Develop contingency plans and backup scenarios to proactively mitigate unforeseen circumstances.
• Oversee relationships with CROs and internal labs to ensure the timely completion of assay development, qualification, and validation studies, delivering high-quality data for translational research projects.
• Develop early translational strategies, including indication prioritization, patient enrichment/selection, and on- treatment pharmacodynamic biomarkers.
• Employ pre-clinical models to establish exposure, biomarker, and efficacy relationships.
• Represent the organization at scientific conferences and events.
• Contribute to the preparation of regulatory submissions, scientific publications, and presentations, effectively communicating translational research outcomes.
• Maintain a professional and credible image with key physicians, consultants, suppliers, and co-workers.
• Actively work to promote team building and morale within the department.

Qualifications and Experience

• Master’s degree or PhD with over 5 years relevant experience.
• A background in Cell Therapies (Stem cell, T-cells or iPSC-derived cell therapies preferred)
• Experience managing a team and external vendors (CRO's and consultants etc)
• Experience with animal models and IND documentation!
• Extensive experience and proven success in translational and nonclinical study design and execution of IND-enabling activities leading to successful regulatory submissions.
• Strong knowledge of FDA regulatory requirements.
• A commitment to generating data of the highest integrity, complying with regulatory requirements and ethical standards.
• Excellent project management, organizational and leadership skills.
• Excellent communication and collaboration skills across levels and functions.
• Ability to work independently and collaboratively in a highly dynamic work environment.

Please apply directly to learn more or email me directly -