The Senior Director of Nonclinical Toxicology & Pharmacokinetics is responsible for overseeing the strategic direction, execution, and integration of nonclinical safety, pharmacokinetics (PK), and advanced modeling—including Quantitative Systems Pharmacology (QSP) to support drug development from discovery through clinical stages across all Therapeutic Areas. This role ensures that all Toxicology and Pharmacokinetic data support regulatory submissions and clinical development and thereby enable effective FIH transition and provide data-driven insights to inform decision-making. Strategic
Leadership:
Lead the nonclinical safety and PK/QSP strategy across all therapeutic areas.
Drive the integration of Tox/PK data into broader R&D strategies.
Serve as a key member of the NCD leadership team, contributing to strategy decisions, data review and risk assessments
Provides technical reports and advice to senior management, planning and engineering personnel
Scientific Oversight:
Oversee the design, execution, and interpretation of toxicology, ADME/PK/QSP/PBPK studies performed at CROs and provide scientific rationale and data interpretation for advancing candidates into early clinical development.
Lead Early Nonclinical Safety Assessments.
Guide the development and application of modeling approaches (e.g., QSP, PBPK, PK/PD) to support dose selection and nonclinical and clinical trial design.
Ensure integration of nonclinical data into clinical development plans and regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs).
Ensure compliance with GLP and ICH guidelines for nonclinical studies.
Cross-functional Collaboration:
Collaborate with relevant R&D functions to align Tox/PK insights and strategies with development goals.
Provide expert input into due diligence for in-licensing or partnership opportunities.
Collaborate with External Study Management for study execution at CROs.
Present findings at internal meetings, scientific conferences, and in peer-reviewed publications.
Team Leadership:
Build and mentor a multidisciplinary team of toxicologists, pharmacokineticists, and modelers.
Foster a culture of scientific excellence, innovation, and continuous learning.
Responsible for leadership and development of toxicology research employees at multiple relevant R&D locations PhD, DVM, or PharmD in Toxicology, Pharmacology, Pharmaceutical Sciences, or related field.
12+ years of experience in nonclinical drug development within the pharmaceutical or biotech industry with proven and deep understanding of pharmaceutical development-scientific and people leadership
Experience with a range of therapeutic modalities (e.g., small molecules, biologics) is a plus.
Proven expertise in toxicology, PK, and modeling (including QSP and PBPK)
Proven track record of leading cross-functional teams and managing complex development programs.
Deep understanding of regulatory requirements and industry best practices in toxicology and PK.
Strong leadership, communication, and cross-functional collaboration skills.
Proven experience leading cross-functional, multicultural and international product development teams
Excellent communication skills (English language)
Our Benefits
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