Madrigalpharma
Director of Preclinical Toxicology & ADME
Madrigalpharma, Conshohocken, Pennsylvania, United States,
We are seeking a highly experienced and motivated Director of Preclinical Toxicology & ADME to join our dynamic team. This leadership role will be instrumental in driving the preclinical drug development process, focusing on preclinical candidate toxicology as well as on the absorption, distribution, metabolism, and excretion (ADME) properties of new drug candidates. The successful candidate will have substantial experience as Study Director managing preclinical studies hands-on and through external Contract Research Organizations (CROs), with expertise in both non-GLP and GLP (Good Laboratory Practice) environments.Position Responsibilities:
Lead and manage the preclinical toxicology and ADME function, providing scientific and strategic leadership in the design, execution, and interpretation of preclinical studies.Oversee the development and implementation of toxicology strategies as a Study Director to support the selection and optimization of drug candidates.Manage relationships with CROs, ensuring the successful outsourcing, execution, and quality control of toxicology studies in both non-GLP and GLP settings.Collaborate closely with cross-functional teams, including medicinal chemistry, pharmacology, clinical development, and regulatory affairs, to ensure alignment of outsourced toxicology and ADME studies with overall project goals.Interpret and integrate data from toxicology and ADME studies to assess the safety and efficacy profiles of drug candidates.Provide expert guidance on preclinical toxicology and ADME aspects in the preparation of regulatory submissions (e.g., IND, NDA, MAA).Keep abreast of the latest advancements in toxicology, ADME, and drug metabolism, incorporating new approaches and technologies into the drug development process.Contribute to the overall strategy and direction of the preclinical development function within the company.Qualifications:
Ph.D. in Toxicology, Pharmacokinetics or a related field.A minimum of 10 years of experience in preclinical toxicology and ADME within the pharmaceutical or biotechnology industry.Must (or preferable to) have DABT (Diplomate of the American Board of Toxicology) certification.Extensive experience managing preclinical studies through external CROs, with proven ability to oversee outsourced toxicology and ADME work in both non-GLP and GLP environments.Proven track record in leading and delivering successful drug development programs, with a strong understanding of the drug discovery and development process.Expertise in designing, executing, and interpreting ADME and toxicology studies.In-depth knowledge of regulatory requirements and guidelines for preclinical safety assessment.Strong leadership and management skills, with the ability to inspire and guide a team of scientists.Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.Experience in metabolic disease drug development is highly desirable.Preferred Qualifications:
Experience with small molecules, biologics, or both.Familiarity with toxicology platforms including, in vitro toxicology and metabolic investigations, predictive and omics-based toxicology approaches and in vivo toxicology and pathology.Familiarity with emerging technologies in ADME, such as in vitro and in silico modeling, PKPB modeling, Phoenix WinNonlin, bioanalytical platforms, and in vitro cell based ADME platforms.Publications in peer-reviewed journals or presentations at scientific conferences in relevant fields.Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
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Lead and manage the preclinical toxicology and ADME function, providing scientific and strategic leadership in the design, execution, and interpretation of preclinical studies.Oversee the development and implementation of toxicology strategies as a Study Director to support the selection and optimization of drug candidates.Manage relationships with CROs, ensuring the successful outsourcing, execution, and quality control of toxicology studies in both non-GLP and GLP settings.Collaborate closely with cross-functional teams, including medicinal chemistry, pharmacology, clinical development, and regulatory affairs, to ensure alignment of outsourced toxicology and ADME studies with overall project goals.Interpret and integrate data from toxicology and ADME studies to assess the safety and efficacy profiles of drug candidates.Provide expert guidance on preclinical toxicology and ADME aspects in the preparation of regulatory submissions (e.g., IND, NDA, MAA).Keep abreast of the latest advancements in toxicology, ADME, and drug metabolism, incorporating new approaches and technologies into the drug development process.Contribute to the overall strategy and direction of the preclinical development function within the company.Qualifications:
Ph.D. in Toxicology, Pharmacokinetics or a related field.A minimum of 10 years of experience in preclinical toxicology and ADME within the pharmaceutical or biotechnology industry.Must (or preferable to) have DABT (Diplomate of the American Board of Toxicology) certification.Extensive experience managing preclinical studies through external CROs, with proven ability to oversee outsourced toxicology and ADME work in both non-GLP and GLP environments.Proven track record in leading and delivering successful drug development programs, with a strong understanding of the drug discovery and development process.Expertise in designing, executing, and interpreting ADME and toxicology studies.In-depth knowledge of regulatory requirements and guidelines for preclinical safety assessment.Strong leadership and management skills, with the ability to inspire and guide a team of scientists.Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.Experience in metabolic disease drug development is highly desirable.Preferred Qualifications:
Experience with small molecules, biologics, or both.Familiarity with toxicology platforms including, in vitro toxicology and metabolic investigations, predictive and omics-based toxicology approaches and in vivo toxicology and pathology.Familiarity with emerging technologies in ADME, such as in vitro and in silico modeling, PKPB modeling, Phoenix WinNonlin, bioanalytical platforms, and in vitro cell based ADME platforms.Publications in peer-reviewed journals or presentations at scientific conferences in relevant fields.Compensation:
Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.
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