Vice President Research And Development (Cambridge)

Thymmune Therapeutics is a preclinical biotechnology company based in Cambridge, MA applying proprietary insights in thymic engineering to develop and commercialize immune cell therapy products addressing significant opportunities with unmet clinical need across immunology. Building on work from leading labs, Thymmune has strong IP positioning and is backed by early investors and founders of successful high-profile biotechnology companies. Our innovation and value-driven organization is seeking to hire an experienced and visionary Vice President, Research & Development to lead the R&D team and advance the technology. This strategic leader will be responsible for overseeing the development and execution of innovative research strategies, driving product development from concept through commercialization, and ensuring alignment with our company's growth objectives. The ideal candidate will bring a deep understanding of long-term drug delivery systems, with a proven track record of successful R&D leadership in the biotechnology sector. They should possess exceptional strategic planning skills, a strong ability to foster crossfunctional collaboration, a demonstrated aptitude for managing complex projects and a history of driving innovation. This role requires a blend of scientific expertise, business acumen, and leadership skills to navigate the evolving landscape of immune cell therapy and deliver groundbreaking solutions that enhance patient outcomes. Key Responsibilities: Oversee research, translational and nonclinical study strategy, design, and execution for the pipeline. Collaborate with cross-functional project teams for design, coordination, and execution of research, translational and nonclinical development strategies. Develop and present Pharmacology, Biodistribution, Immunology, and Toxicology strategies, plans and data at project team meetings and to management to support project objectives. Provide oversight for establishment of research scale processes and associated analytical methods. 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 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. 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. Develop contingency plans and backup scenarios to proactively mitigate unforeseen circumstances. Establish, implement, and proactively manage effective R&D programs, processes, and strategies designed to meet corporate goals and objectives. Oversee and manage the R&D pipeline, including discovery, research , preclinical, and clinical development, ensuring alignment with corporate objectives. Collaborate with internal and external stakeholders, including the Regulatory, Manufacturing/CMC, Quality, and external consultant to determine new product development strategy from product inception to market launch. Engage with clinical Key Opinion Leaders, describing the platform, preclinical and clinical opportunities to enable patient recruitment. Facilitate access to real world and clinical trial datasets. Recruit, lead and mentor the R&D team, comprising scientists, engineers, and technicians. Build and execute translational plans that allow patient selection and stratification, early markers of clinical activity, as well as providing key mechanistic insights. Maintain a clear channel of communication with senior management team regarding program progress, risks, challenges, and opportunities. Effectively manage all aspects of the research and development effort including participation in program teams. Develop research proposals to collaborate with institutions, co-operative groups, and pharmaceutical companies on development studies. Oversee the R&D budget, allocating resources effectively to prioritize key projects and ensure efficient use of funding. Stay abreast of market trends, competitive landscape and emerging technologies to inform decision-making and identify opportunities for innovation. Participate in Senior Staff meetings and planning sessions, and regularly make presentations to Thymmune senior management. Represent the organization at scientific conferences and events. Contribute to the overall intellectual property position of the company by actively encouraging and managing invention and patent applications. 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 Required Bachelors/Masters degree required, with a degree in Pharmacokinetics, Biology, Pharmacology, Immunology, or a related discipline preferred. 14+ years experience (with Bachelors/Masters degree) in a leadership role overseeing drug development programs in biotechnology or pharmaceutical industry, preferably in Cell and Gene therapy At least 7 years of supervisory experience. Cell therapy experience is a must. A background/experience in iPSC-derived cell therapies is strongly preferred. Experience managing a team of colleagues with advanced degrees (e.g., Ph.D.) including professional development and performance management. Extensive experience and proven success in translational and nonclinical study design and execution of IND-enabling activities leading to successful regulatory submissions. A commitment to generating data of the highest integrity, complying with regulatory requirements and ethical standards. Excellent project management, organizational and leadership skills. Comprehensive understanding of the entire drug development process, including basic knowledge of regulatory environments, clinical development, and Chemistry, Manufacturing, and Controls (CMC). Proven experience building and leading development teams focused on milestonebased scientific discoveries. Proven experience in a critical role responsible for shaping companys research and development strategy and advancing its mission. Preferred Ph.D. degree with at least 15 years of experience is preferred. Excellent communication and collaboration skills across levels and functions. Ability to work independently and collaboratively in a highly dynamic work environment. Strong initiative, accountability, and willingness to take ownership and drive projects to completion. Ability to set priorities, work independently and deliver results in a timely manner. Sound strategic, technical, operational, and ethical judgment with uncompromising integrity. Prior experience with the preparation of toxicology data using FDA SEND (Standard for Exchange of Nonclinical Data) format.

Created: 2025-09-24