The Director of ADME/PK will be involved in the design, execution, analysis, interpretation and communication of nonclinical ADME/PK studies of small molecule and their associated delivery system to provide nonclinical ADME/PK profiles and risk assessment to support drug development. This position requires strong intellectual leadership, working at the interface of discovery and development teams and will serve as the nonclinical subject matter expert. The incumbent will design, conduct, and interpret nonclinical ADME/PK and investigational studies; will advise management on the pharmacokinetic aspects of the project and will effectively communicate with worldwide regulatory agencies to bring our drugs to patients as quickly as possible. This is an ideal position for an independent individual with a strong background in discovery and preclinical ADME/PK who enjoys working in a team-oriented and highly cross-disciplinary environment.
- Design, plan, monitor and conduct nonclinical ADME/pharmacokinetic studies to support drug candidate nomination and through the lifecycle of small molecule candidates in-house and at contract research organizations.
- Interpret ADME/ pharmacokinetic data to inform the design of pharmacology and toxicology studies.
- Interpret pharmacokinetic data to inform human dose projections.
- Conduct or be accountable for PKPD modeling activities to estimate efficacious dose and exposure range in humans along with therapeutics margins for nonclinical studies.
- Serve on research project teams as preclinical pharmacokinetics representative.
- Collaborate closely with bioanalytical scientists and toxicologists.
- Draft nonclinical pharmacokinetic sections of regulatory documents.
- PhD degree in pharmaceutics, pharmacokinetics, pharmacology, or related discipline.
- Minimum 10 years-experience in the pharmaceutical industry in the area of preclinical drug discovery and/or development.
- Experience in the conduct, analysis and interpretation of in vitro and vivo ADME/PK studies.
- Experience with small molecule pharmacokinetics and drug development.
- Experience with PKPD model development and human dose projections preferred.
- Must be detail oriented with strong documentation and organizational skills.
- Excellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholders.
- Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders.
- Strong research background and interest in understanding PK data in the context of complex biology.
- Proven ability to work independently and be self-motivated.
EEO & Employment Eligibility
Turning Point Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Turning Point Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Turning Point Therapeutics is an E-Verify employer.
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