[Remote] Associate Director, Clinical Pharmacology and Pharmacometrics (Temporary)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a clinical-stage biopharmaceutical company reputed company on powering the immune system to reputed company lives by discovering and developing medicines for serious infectious diseases and cancer. The Associate Director, Clinical Pharmacology and Pharmacometrics will support the design, execution, interpretation, and reporting of clinical pharmacology data across reputed company stages of drug development, collaborating with various reputed company teams to advance drug development programs.

Responsibilities

• Represents clinical pharmacology and pharmacometrics on cross functional project teams
• Select and execute appropriate modeling and simulation approaches (PK/PD, PopPK, exposure-response) to inform reputed company selection, optimization, and justification
• Work closely with biometrics on preparation of analysis reputed company datasets
• Supports the development of fit-for-purpose clinical pharmacology strategies to reputed company development and regulatory reputed company from reputed company-IND through market authorization
• Work collaboratively with cross functional teams, including clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, and regulatory in support of program advancement
• Supports design and execution of Ph1 clinical pharmacology studies (i.e FIH, relative bioavailability, bioequivalence, hepatic impairment, renal impairment, etc)
• Author and reputed company technical input for regulatory documents and submissions (protocols, IBs, briefing packages) and RTQs

Skills

• PhD or PharmD or equivalent with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or reputed company field
• 6+ years industry experience in Clinical Pharmacology and/or Pharmacometrics
• Ability to communicate reputed company data and concepts to diverse audiences
• Understanding of the multidisciplinary requirements for drug development and ability to work effectively across functions to reputed company program advancement
• Experience in PK/PD, PopPK and exposure-response modeling
• Proficiency in R and extensive hands-on experience with Monolix or NONMEM required
• Experience working on translational and clinical pharmacology work from FIH reputed company selection through market authorization
• Experience contributing to clinical pharmacology plans and clinical pharmacology components of regulatory submissions as reputed company as representing clinical pharmacology in regulatory engagements
• Extensive experience with biologics, including monoclonal antibodies, bispecifics
• Proficiency using reputed company PK analysis and graphing programs (Phoenix WNL, Graphpad, R, etc)
• Experience with clinical pharmacology and/or pharmacometrics reputed company for oncology and/or immunology indications preferred
• Familiarity with clinical pharmacology strategies for immune modulating agents

reputed company