Associate Director, Translational Research and Non-Clinical Lead
EVOLVEIMMUNE THERAPEUTICS INC
Summary
Lead the translational research and non-clinical development for the EVOLVE project portfolio, developing and implementing strategy for translational and non-clinical safety/pharmacology assessments to support clinical positioning and IND-enablement of development candidates.
Job description
What You'll Work On
- 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 and other regulatory guidelines where appropriate
- Manage 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 company communication strategy through presentations to Board of Directors, investors, collaboration partners, and 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
What You Bring
- 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
Requirements
- PhD in Immunology or related field
- At least 5 years of relevant industry experience
- Experience working with primary human tissues/models
- Experience with oncology biologic drug safety, pharmacology and toxicology assessments
- Experience with 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
- Experience 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
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Parental Leave
- 4 Weeks PTO
- Paid Holidays
- Cellphone Reimbursement
- 401(k) Plan
- Life Insurance
- Disability Insurance
- Annual Incentive Compensation
- Equity
Company overview
EvolveImmune Therapeutics Inc. is an innovative biotechnology company headquartered in Branford, Connecticut, focused on developing next-generation cancer immunotherapies. Founded in 2020, the company specializes in creating first-in-category, multifunctional biotherapeutics designed to overcome cancer-driven immunodeficiency in both solid tumors and hematological cancers. EvolveImmune's proprietary EVOLVE platform pioneers unique trispecific T cell engagers with integrated CD2 costimulation, addressing critical challenges of cancer cell resistance to current immunotherapies. The company's lead internal drug candidate, EVOLVE104, is scheduled to enter clinical trials in 2025. With approximately 57 employees and backed by top-tier life science investors including Pfizer Ventures, Solasta Ventures, and Takeda Ventures, EvolveImmune is advancing a pipeline of novel immunotherapies that aim to provide more effective and durable anti-tumor responses while reducing T cell exhaustion and cytokine release syndrome risks.