Associate Director, Nonclinical Study Management

Kelly® Science & Clinical is seeking an Associate Director, Nonclinical Study Management for a direct hire opportunity with one of our clients, a precision immunology bio-therapeutics company focused on the development of disruptive therapies for the treatment of autoimmune, allergic, and inflammatory disorders. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Position Title: Associate Director, Nonclinical Study Management

Position Type: Direct hire

Salary: $180,000-205,000/year

Workplace: Onsite in the San Francisco Bay Area

Join a pioneering biotechnology company advancing a robust pipeline of next-generation biologics—ranging from bispecific antibodies to antibody-drug conjugates—designed to address significant unmet needs across immunology and allergy. We are seeking an accomplished Senior/Associate Director to lead nonclinical safety study management (Toxicology and Bioanalytical), driving the operational execution of in vitro and in vivo safety, pharmacokinetic, and tissue cross-reactivity studies supporting IND-enabling and clinical-stage programs. This critical role partners closely with Research, CMC, Quality, Regulatory, and Clinical functions to deliver high-impact nonclinical data within aggressive development timelines.

Key Responsibilities

• Independently manage all aspects of outsourced nonclinical studies: from test article forecasting, analytical logistics, and protocol authorship to IACUC approvals, real-time monitoring, data/report reviews, SEND dataset management, and archiving.
• Serve as the lead study manager for IND-enabling programs: build and refine the integrated nonclinical timeline, resolve formulation/material issues, run internal/external kickoff meetings with CROs, and oversee comprehensive report reviews.
• Drive the preparation and quality control of nonclinical modules and sections for regulatory submissions (IND, IB, NDA/BLA), including detailed summaries, narratives, and data visualizations.
• Offer scientific and technical expertise to anticipate, mitigate, and resolve study-related challenges; function as a subject matter expert in nonclinical study design for complex biologics and small molecules.
• Present study design and key findings clearly to internal teams, leveraging effective written and visual communication.
• Conduct literature reviews to inform study design, species selection, and risk/benefit assessments for novel modalities.
• Support CRO selection, qualification, and site visits; play a key role in vendor governance and ongoing performance oversight.
• Domestic travel (up to 15%) required, primarily for CRO relationship management and onsite study oversight.

Qualifications

Required:

• Bachelor’s degree (10+ years), Master’s degree (8+ years), or an equivalent combination of education and experience in pharmaceutical, biotech, or CRO drug development, in disciplines such as toxicology, pharmacology, biology, or biochemistry.
• Strong track record in GLP-regulated nonclinical safety study management and familiarity with FDA, ICH, and EMA guidelines.
• Hands-on experience designing and managing both biologic and small molecule studies (in vitro and in vivo).
• Solid background in toxicology, mammalian biology, and physiology, with a data-driven approach to study interpretation.
• Familiarity with animal welfare standards (USDA, AAALAC, OLAW) and IACUC processes.
• Exceptional organizational skills, attention to detail, and the capacity to simultaneously prioritize multiple projects on compressed timelines.
• Strong written and verbal communication, analytical, and interpersonal skills; demonstrated ability to work independently and lead cross-functional teams.

Preferred:

• Experience preparing for and supporting IND submissions, including authoring nonclinical modules (Module 2.6 and Module 4)
• Direct experience with bispecific antibodies, ADCs, or other complex biologic entities.
• Knowledge of tissue cross-reactivity (TCR) studies, immunogenicity assessment, and cytokine release testing.
• Prior hands-on work within immunology, allergy, or inflammation therapeutic areas.

Compensation & Benefits

• Competitive base salary, commensurate with qualifications and experience.
• Significant equity participation in a fast-growing, innovation-driven biotech organization.
• Annual performance-based bonus.
• Comprehensive health benefits for employees and dependents, including medical, dental, and vision.
• Company-supported 401(k) plan.
• Generous paid time off, paid holidays, and paid parental leave.

Diversity & Inclusion

Our client is an equal opportunity employer, committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, disability, or veteran status.