Associate Director, Translational Research and Non-Clinical Lead

EVOLVEIMMUNE THERAPEUTICS INC•Branford, CT

3d•Onsite

About The Position

EvolveImmune Therapeutics is seeking an Associate Director, Translational Research and Non-Clinical Lead to join their Translational Sciences team. This role will lead the translational research and non-clinical development for the company's EVOLVE project portfolio. The successful candidate will be responsible for developing and implementing strategies for translational and non-clinical safety/pharmacology assessments to support clinical positioning and IND-enablement of development candidates. This position involves working with patient-derived tissue samples and organoids to gain insights into the differentiation and mode of action of emerging assets. The role includes overseeing junior laboratory scientists, managing data generation for non-clinical in vitro assays, and potentially utilizing bioinformatics. Strong collaboration, communication, leadership, and a proven track record in biopharma are essential.

Requirements

PhD in Immunology or related field with at least 5 years of relevant industry experience
Experience in working with primary human tissues/model, oncology biologic drug safety, pharmacology and toxicology assessments and successful submissions of regulatory documents (INTERACT/pre-IND) and non-clinical study packages to FDA
Proven ability to manage complex projects to achieve milestones in a timely manner, including managing internal work, collaborations with external consultants and CROs
Strong verbal and written communication and presentation skills
Track record of success as defined by publication, patent and/or drug development record

Nice To Haves

Experience with bioinformatics is a plus.

Responsibilities

Establish organoids/primary cell systems to evaluate drug responses in complex human tissues
Evaluate target expression including development of IHC assay
Define and execute the non-clinical safety, pharmacology and toxicology strategy for each program including overseeing dose modeling, establishing exposure response and determining efficacious and FiH doses
Lead efforts to plan and execute in-house and external IND enabling studies with adherence to GLP (Good Laboratory Practice) and other regulatory guidelines where appropriate
Manages CRO partnerships, study design, monitoring, and data reporting
Partner with the Immunobiology, Biotherapeutics teams to facilitate the progression of programs from discovery to clinical development
Partner with Regulatory, CMC and Clinical Development teams to support IND
Prepare documentation for regulatory submissions, including INDs
Mentor our scientific team and support individual career development for team members
Contribute to our company’s communication strategy to drive the visibility and recognition of our scientific strategy and company milestones in presentations to our Board of Directors, investors, collaboration partners, and through presentations at external scientific conferences
Work with project management to develop timelines and budgets, and ensure deliverables are achieved in a timely fashion
Ensure compliance with all health and safety protocols