Job Description Associate Director, Clinical Pharmacology

 Role Description:

The associate Director of Quantitative Clinical Pharmacology will provide expertise in the area of clinical pharmacology and pharmacokinetic/pharmacodynamic support to the project teams at Mirati Therapeutics and will be responsible for the clinical pharmacology components (including protocols, analysis plans, study reports, etc.) of all relevant clinical studies and regulatory documents. In this role he/she will work closely with clinicians, statisticians, translation oncology, toxicology and regulatory affairs colleagues to create clinical development plans that include assessment of a drug’s efficacy, safety and pharmacologic properties.

Responsibilities:

  • Work as part of the clinical pharmacology/pharmacometrics team and in collaboration and interaction with other functions in multiple clinical development programs
  • Contribute to and implement an overall nonclinical and clinical PK/PD development strategy to support all stages of drug development
  • Prepare study synopses, protocols, study reports and regulatory documents to support the clinical and nonclinical pharmacology development
  • Identify/develop and apply new quantitative methods as needed to solve problems in pharmaceutical research and drug development
  • Implement and advance PK/PD modeling and simulation approaches focusing on immuno-oncology therapies
  • Play a key role in managing studies PK operations with CROs and contracted vendors and proactively providing technical input on quantitative issues
  • Contribute with project teams/partners to all regulatory documents including Investigator Brochures, EOP2 meetings, IND/NDA/IMPDs/sNDAs
  • May participate in multidisciplinary teams in supporting due diligence efforts for new business opportunities that are under consideration and managing clinical pharmacology alliance with current and potential partners

Education/ Skills Required: 

  • Pharm.D and/or PhD degree with training and/or expertise in one or more areas related to pharmacometrics, clinical pharmacology or preclinical ADME studies
  • 3 to 5 years of industry or consulting experience (may be combined with academic research) working in R&D, pre-clinical and or clinical environments
  • Experience in pharmacometrics, clinical pharmacology, pharmacokinetics, model-Based Drug Development in a project team setting in academia or industry
  • Experience with PK/PD modelling with strong quantitative skills
  • Broad translational and clinical development expertise with emphasis on Pharmacometrics
  • Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management and filings is preferred
  • Advanced user of modelling software such as WinNonlin Phoenix, NONMEM, S-Plus/R
  • Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment, balancing multiple responsibilities, projects and teams simultaneously
  • Ability to work well with external vendors and collaborators with courtesy and professionalism
  • Good communication skills (written, oral presentation)