JOB DESCRIPTION:
 Generate Clinical Pharmacology Development Plan for compound candidates (Phase I to III).
 Maintenance and execution of the plan through close collaboration with other Early Drug Development and Clinical Research & Development departments. ·
 Assist in the planning, implementing, interpreting and reporting of clinical pharmacology components of Phase I to III studies.
 Lead clinical pharmacokinetic studies in healthy subject and special population.
 Analyze data to determine the pharmacokinetics of the compound.
 Familiar with population pharmacokinetics study designs and analytical methodology.
 Assist in the characterization of the safety and tolerance of test compounds in healthy volunteers and/or patients.
 Collaborate with Experimental Medicine in the determination of PK/PD relationship with the appropriate pharmacodynamic response or biomarkers.
 Generate clinical pharmacology documents in support of global regulatory submission.
 Other responsibilities include: 1. Oversees the activity of contractors, consultants and CRO's as assigned by the Director, Clinical Pharmacology. 2. Track progress of all assigned programs and associated trials and deliverables 3. Assists the Director in formulating budgets for assigned studies and works with Operations Department and Director in selecting CRO's, obtains contracts and authorizes grant payments to be processed against grants. Tracks grant payments against contracts and annual Clinical Pharmacology budget. 4. Assures GCP. 5. Forecasts drug supply needs for assigned trials. 6. Identifies and selects study sites. 7. Performs various departmental, organizational and/or administrative duties as assigned by the Director, Clinical Pharmacology. 8. Some travels will be required.
JOB REQUIREMENTS:
 A Ph.D. or Pharm.D. or equivalent in the life sciences with at least 3 years of relevant industrial clinical research experience in clinical pharmacology is required.
 Knowledge of drug development, clinical research concepts and practices, pharmacodynamics and clinical pharmacokinetics, and FDA regulations regarding conduct of clinical studies (GCP) is highly desired.
 The incumbent must demonstrate the ability to design, coordinate, and analyze clinical pharmacology studies.
 The incumbent must possess excellent analytical and problem solving skills.
 The incumbent should have well developed oral communication and interpersonal skills as well as excellent writing skills.
 Broad knowledge of data processing methods and statistical analyses is preferred.
 The incumbent is required to have good project and time management skills so that tight deadlines can be met.
 The incumbent will represent Clinical Pharmacology at the multi-disciplined clinical project teams. The incumbent should communicate effectively issues to the appropriate parties.
 Excellent organization, managerial, and interpersonal skills are important.
 Ability and willingness to work within a matrix environment and ability to function as representative on project teams are required. Responsibilities
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