Job Description

Job Description

Job Description

Salary: $295,000 - $338,300

PURPOSE OF JOB:

The Senior Director, Toxicology & DMPK is responsible for providing nonclinical safety and DMPK expertise for the development of both oral, small molecules and biologics across the companys discovery and development pipeline. This individual will serve as the primary expert in predicting and characterizing human safety and exposure, integrating toxicology, ADME, and PK/PD insights to support candidate selection and clinical development. Reporting to the Chief Scientific Officer, the role is highly strategic and collaborative, interfacing with discovery biology, clinical pharmacology, regulatory affairs, and program leadership.

MAJOR DUTIES AND RESPONSIBILITIES:

• Provide scientific and strategic leadership for all toxicology and DMPK activities across small molecules and biologics
• Design and oversee preclinical toxicology and safety pharmacology plans, including GLP studies, mechanism-based investigations, and regulatory submission packages
• Select and oversee CROs to conduct GLP safety and toxicology studies
• Evaluate and strategically implement established in vitro toxicology assays and in silico tools that support safety assessment in drug discovery
• Collaborate with in-house vivarium team to design and coordinate in-house tolerability studies in rodents
• Direct the DMPK function encompassing in vitro ADME profiling, in vivo PK, and translational modeling to enable confident human dose projections
• Serve as the nonclinical safety lead on project teams and communicate risk assessments to senior management
• Partner with discovery and development teams to guide candidate optimization with respect to metabolic stability, clearance, and exposure margins
• Develop and maintain relationships with CROs, ensuring quality, timelines, and budget compliance
• Interpret results, and author, review, and approve nonclinical sections for INDs, IBs, and regulatory responses
• Lead and mentor DMPK scientists, cultivating innovation, scientific rigor, and operational excellence
• Keep abreast of regulatory and scientific developments relevant to safety assessment, translational toxicology, and model-informed drug development
• Represents nonclinical safety in interactions with regulatory agencies (e.g., FDA, EMA, PMDA)

EDUCATION REQUIREMENTS:

• Ph.D. in Toxicology or a related discipline (e.g., Pharmacology, Pharmaceutical Sciences, or ADME sciences), DABT preferred. Exceptional candidates with a Pharm.D. or M.S. and extensive (15+ years) experience leading nonclinical safety and DMPK programs will be considered.

EXPERIENCE REQUIREMENTS:

• 15+ years of experience, including at least 7 of those years independently leading toxicology and DMPK teams and programs.
• Proven track record leading integrated nonclinical safety and PK strategies supporting small molecule and biologic programs through IND and clinical phases.
• Deep understanding of ADME processes, species translation, IVIVE, allometric scaling, and human dose prediction methods.
• Experience managing GLP tox studies and authoring regulatory submissions in the US and ex-US.
• Knowledge of immunology or inflammation is a plus.

OTHER QUALIFICATIONS:

• Experience in designing toxicology and safety assessments for advanced stage clinical candidates.
• Excellent leadership and teamwork skills to allow effective interaction with both preclinical, clinical and regulatory team members.
• Excellent problem-solving skills, applying scientific methods to resolution of critical issues.
• Excellent written and oral communication skills with the ability to present internally and externally.
• Strong motivation, independence, and ability to work in a high-pace multidisciplinary environment with minimal supervision.
• The candidate should also enjoy operating in an exceptionally dynamic, high-achieving and cooperative environment where every voice matters.
• Cultivates an open, transparent, and collaborative environment.

PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS:

This position is preferred as on-site for local candidates. Hybrid flexibility may be considered for exceptional candidates.

California law requires pay information in job postings. The specific rate will depend on the successful candidates qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is $295,000 (entry-level qualifications) to $338,300 (highly experienced).

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