Associate Director, Nonclinical Program Development (Biotech)

Location: Hybrid in Boston, Massachusetts, United States; minimum two days on-site per week, currently Tuesday and Wednesday

Salary: $181,000–$214,000 USD annually, plus potential discretionary bonus and long-term incentive award.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Support nonclinical toxicology and integrated safety strategies across the immunology and inflammation pipeline.
• Plan and manage study timelines, risks, deliverables, repositories, and cross-functional action plans.
• Oversee CRO and vendor execution, including study start-up, protocol review, monitoring, quality oversight, data delivery, and final reports.
• Author and coordinate nonclinical study reports, IND-enabling documentation, CTD sections, briefing materials, and health authority responses.
• Identify safety risks, interpret emerging data, and develop mitigation strategies for development programs.
• Bridge nonclinical findings with clinical biomarker strategies, sample collection, laboratory readiness, and first-in-human monitoring.

Requirements

• Advanced degree in toxicology, pharmacology, immunology, biology, biomedical sciences, or a related field.
• 7+ years of relevant biotechnology, pharmaceutical, CRO, academic, consulting, or translational research experience.
• Experience with nonclinical toxicology strategy, IND-enabling studies, GLP studies, safety pharmacology, PK/PD, toxicokinetics, and biodistribution.
• Background in immunology, inflammation, autoimmune or immune-mediated diseases, T-cell biology, cell therapy, biologics, gene therapy, or other novel modalities.
• Experience supporting first-in-human readiness, clinical biomarker strategy, translational safety monitoring, and regulatory submissions.
• Strong program management, CRO/vendor management, cross-functional coordination, risk tracking, and scientific communication skills.

Culture & Benefits

• Work in a fast-moving, resource-conscious biotech environment with a hands-on operating model.
• Collaborate with multidisciplinary internal teams, academic partners, consultants, and CROs.
• Hybrid work schedule with flexible arrangements.
• Benefits may include health and wellness coverage, paid time off, public holidays, and additional leave according to local requirements.