JOB SUMMARY:

Serves as the primary clinical pharmacology lead providing clinical pharmacology, translational and quantitative clinical pharmacology expertise to a multidisciplinary study team. Responsible for programs in clinical development and is the key expert on all clinical pharmacology & pharmacometrics matters relating to assigned clinical projects. Work in close collaboration with different functions including preclinical toxicology, preclinical pharmacokinetics, preclinical research, translational medicine, regulatory affairs, biometrics and clinical research.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Design and implement Clinical Pharmacology plans using traditional and model informed drug development approaches and will manage the clinical pharmacology study process from protocol development to final study reporting
• Evaluate and perform hands-on analysis of clinical PK/PD data; authorize PK clinical study reports

• Supports the development and execution of the quantitative clinical pharmacology strategy of nonclinical and clinical development teams
• Ensure appropriate planning and execution of data modelling/pharmacometrics activities in support of projects and perform advanced quantitative pharmacology and pharmacometrics analyses to support Zentalis portfolio.
• Manage external vendors to ensure high quality M&S deliverables and adherence to planned timelines/budgets.
• Maintain a current understanding of PK and PD literature and methodology, as well as the scientific literature related to the specific drug discovery projects

• Contribute to clinical development/ clinical pharmacology strategy and planning for clinical programs
• Ensure timely and accurate communication of study results and interpretation to appropriate internal drug development teams
• Provide PK/PD modeling to support dosing strategies for clinical programs
• Write and edit dose rationale sections of clinical protocols and investigator brochures, INDs, CTAs and NDAs
• Prepare Clinical Pharmacology components of regulatory submissions and represent the Clinical Pharmacology line at meetings with regulatory agencies and health authorities
• Ensure appropriate quality of documentation for internal department studies compatible with global regulatory submission requirements
• Other duties and projects as assigned

EDUCATION/KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

• PhD, MD, or PharmD with relevant expertise in pharmacokinetics, pharmacology or pharmaceutical science is required; minimum of 10-12 years of direct industry experience in conducting clinical stage drug development
• Expert level skills and expertise in modelling and simulation activities (NCA, population PK/PD modelling, literature meta-analyses, exposure-response analyses)
• Expert knowledge and hands-on experience in NONMEM or Monolix, R, and/or SAS.
• Additional experience with Stan, Phoenix/nlme, SAS, Python, Julia, or other mixed effects software is preferred
• Experienced in developing clinical pharmacology plans and in the preparation of regulatory submissions (including INDs, NDAs, BLAs and/or significant sNDAs/sBLAs)
• Experienced in responding to regulatory questions related to all aspects of clinical pharmacology
• Knowledge, Skills and Abilities
• Knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, oncology, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, and toxicology
• Population PK/PD analysis and PBPK modeling experience
• Experience in working with external CROs with timely delivery of clear and accurate well written study findings
• Strong knowledge of clinical drug development and FDA and ICH guidance documents is essential
• Excellent oral, written and presentation skills with the ability to stay organized across multiple projects