Associate Director, Translational Research and Non-Clinical Lead

EVOLVEIMMUNE THERAPEUTICS INC•Branford, CT

22d•$150,000 - $185,000•Onsite

About The Position

EvolveImmune Therapeutics is hiring an Associate Director, Translational Research and Non-Clinical Lead to join its Translational Sciences team in Branford, Connecticut. The role leads translational research and non-clinical development across the company’s EVOLVE project portfolio, developing and implementing strategies for translational and non-clinical safety and pharmacology assessments that support clinical positioning and IND-enablement of development candidates. The position uses patient-derived tissue samples and organoids to investigate emerging assets, including their differentiation and modes of action, and oversees junior laboratory scientists conducting translational research and non-clinical in vitro assays such as MABEL and in vitro safety assays. Bioinformatics experience is a plus. The role collaborates across scientific, regulatory, manufacturing, clinical, and project management teams; manages CRO relationships and IND-enabling studies; and contributes to regulatory submissions and company scientific communications. It also includes mentoring junior scientists and supporting their career development. This is a full-time, onsite position based in Branford, CT. EvolveImmune requires COVID-19 vaccination, with medical and religious accommodations considered.

Requirements

PhD in Immunology or a related field.
At least 5 years of relevant industry experience.
Experience working with primary human tissues or models.
Experience with oncology biologic drug safety, pharmacology, and toxicology assessments.
Experience with successful regulatory document submissions, including INTERACT or pre-IND submissions, and non-clinical study packages to the FDA.
Proven ability to manage complex projects and achieve milestones on time, including internal work and collaborations with external consultants and CROs.
Strong verbal and written communication and presentation skills.
Track record of success demonstrated through publications, patents, and/or drug development.

Nice To Haves

Experience in bioinformatics.

Responsibilities

Establish organoids and primary cell systems to evaluate drug responses in complex human tissues.
Evaluate target expression, including development of an IHC assay.
Define and execute the non-clinical safety, pharmacology, and toxicology strategy for each program, including overseeing dose modeling, establishing exposure-response relationships, and determining efficacious and first-in-human doses.
Plan and execute in-house and external IND-enabling studies in accordance with GLP and other applicable regulatory guidelines.
Manage CRO partnerships, including study design, monitoring, and data reporting.
Partner with Immunobiology and Biotherapeutics teams to advance programs from discovery to clinical development.
Partner with Regulatory, CMC, and Clinical Development teams to support INDs.
Prepare documentation for regulatory submissions, including INDs.
Mentor scientific team members and support their individual career development.
Contribute to company communications that present its scientific strategy and milestones to the Board of Directors, investors, collaboration partners, and external scientific conferences.
Work with project management to develop timelines and budgets and ensure timely delivery of milestones.
Ensure compliance with health and safety protocols.