Role Summary
The Associate Director, Clinical Pharmacology and Pharmacometrics will report to the Executive Director, Clinical Pharmacology and Pharmacometrics and will be responsible for leading clinical pharmacology and pharmacometrics activities within the organization. Working in a collaborative environment, you will be responsible for providing scientific leadership in cross-functional teams to advance VeraβΓΓ΄s drug candidates from IND through Phase IV.
Responsibilities
- Provide clinical pharmacology and pharmacometrics expertise to program and study teams throughout the drug development lifecycle.
- Develop & implement clinical pharmacology and pharmacometrics plans, considering all aspects (strategic, scientific, translational, and clinical).
- Analyze and interpret results from clinical pharmacology and pharmacometrics data analysis, and recommend appropriate actions based on results.
- Serve as lead author and key contributor for clinical pharmacology sections of clinical and regulatory documents.
- Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes.
- Collaborate with Biostats, Data Management, Clinical Operations & Medical to support development projects.
Qualifications
- PhD with 5+ years relevant industry experience (clinical pharmacology, quantitative pharmacology, clinical PK/PD).
- Ability to analyze and interpret PK, PK/PD and pharmacometrics data utilizing sound scientific principles.
- Experience with the use of software packages such as Phoenix, R, NONMEM for PK, PK/PD and pharmacometrics data analysis and modeling and simulation.
- Strength in delivering results on agreed timelines to advance VeraβΓΓ΄s pipeline.
- Excellent oral and written communication skills and ability to effectively collaborate with cross-functional teams and contribute to decisions.
- Experience working in a matrix environment.
- Experience managing collaborations with contract research organizations (CROs), consultants, pharmaceutical partners and other outside organizations.
- Ability to think critically and solve problems, possess a quick and analytical mind, a fast-learner who works well in an organization that highly values intellectual capacity and scientific contributions.