Associate Director, Preclinical & Translation ...

The Associate Director Preclinical and Translation Pharmacology will lead efforts in drug metabolism and pharmacokinetics (DMPK) and preclinical pharmacokinetics (PK), pharmacodynamics (PD), and pharmacometrics analyses to support the development of novel RadioConjucate [RCs] therapeutics. This role will play a pivotal role in advancing oncology RC drugs from discovery through clinical stages. This position requires expertise in preclinical pharmacology, translational science, and a deep understanding of small molecules, peptides, monoclonal antibodies (mAbs), bispecific T-cell engagers (BiTEs), and antibody-drug conjugates (ADCs). The ideal candidate will design and execute strategies to integrate pharmacokinetics (PK), pharmacodynamics (PD), and safety and efficacy biomarker data, ensuring seamless translation of preclinical findings into clinical success. The role also includes operational responsibilities, such as managing relationships with contract research organizations (CROs) and external vendors, ensuring high-quality and timely delivery of data and relevant reports.Responsibilities• Preclinical Pharmacology and DMPK Leadershipo Design and oversee in vitro and in vivo DMPK studies, including absorption, distribution, metabolism, and excretion (ADME) evaluations for different modalities.o Optimize lead candidates by integrating PK/PD relationships, exposure-response data, and preclinical biomarker assessments.o Implement preclinical PK/PD/PMX strategies to effectively translate and guide First in Human(FIH) dose selection, with a focus on integrating pharmacokinetics (PK), pharmacodynamics (PD), safety and toxicokinetic (TK), Biodistribution and efficacy studies.• Pharmacometrics and Translational Modelingo Lead the development of NCA analysis, physiologically based PK [PBPK], mechanistic/semi mechanistic PK/PD and exposure-response models to support dose selection and Phase I clinical trial design.o Use quantitative tools (e.g., population PK, PBPK, and systems pharmacology) to enhance understanding of drug behavior and therapeutic potential.• Cross-functional Collaborationo Partner with discovery, toxicology, clinical pharmacology, and regulatory teams to ensure translational consistency across programs.o Contribute to target validation and candidate selection processes by integrating DMPK data with efficacy and safety profiles.• Regulatory and Documentation Supporto Prepare and authoring PK/PD/DMPK and preclinical pharmacometrics sections for regulatory submissions (e.g., IND) and authoring protocols and IBso Represent the DMPK andpreclinical/translational pharmacometrics functions in regulatory meetings and discussions.• CRO and Vendor Managemento Identify, select, and manage relationships with CROs and external vendors to support preclinical and translational studies.o Negotiate contracts, set study timelines, and ensure the delivery of high-quality, reproducible data.o Oversee external study execution, including ADME, PK/PD, biomarker development, and efficacy studies, ensuring alignment with project goals.o Monitor vendor performance and ensure compliance with regulatory and scientific standards.• Therapeutic Modality Expertiseo Provide strategic leadership for RCs across various therapeutic modalities, including small molecules, peptides, monoclonal antibodies (mAbs), bispecifics (e.g., BiTEs), and antibody-drug conjugates (ADCs).• Leadership and Mentorshipo Supervise and mentor junior scientists in DMPK and pharmacometrics.o Drive innovation in preclinical translation through implementation of state-of-the-art methodologies and technologies.Qualificationso PhD, PharmD, or equivalent in pharmacokinetics, pharmacology, pharmaceutical sciences, or a related discipline.o At least 5+ years of experience in preclinical DMPK and pharmacometrics analyses in the pharmaceutical/biotechnology industry.o Demonstrated expertise in integrating DMPK data into preclinical and clinical development plans.o Experience with regulatory submissions and interactions is preferred.o Proficiency in PK and pharmacometrics software (e.g., Phoenix NLME, NONMEM, Monolix, and R).o Strong understanding of PK, PD, DMPK principles, including in vitro ADME, and bioanalysis techniques.o Familiarity with therapeutic modalities such as small molecules, peptides, mAbs, BiTEs, and ADCs is essential.o Strong leadership and mentoring abilities.o Excellent communication, negotiation, and interpersonal skills.o Strategic thinker with the ability to work effectively in a fast-paced, cross-functional environment.Key Competencies• Expertise in oncology drug development across small molecules and monoclonal antibodies, BiTE, and ADCs• Deep understanding of translational science and biomarker strategies.• Proficiency in integrating preclinical pharmacology into clinical decision-making.• Strong operational and project management skills for CRO and vendor oversight.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran. 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Created: 2025-02-01