Clinical Pharmacologist (Director or Associate Director) - PGxHealth

Position Description

Job Summary

This position has the primary responsibility for the evaluation, design and implementation of Phase I and Clinical Pharmacology development plans.

Essential Functions and Duties

• Directs the activities of a clinical pharmacology group in the analysis of in vivo and in vitro pharmacokinetics and drug metabolism studies working with a multidisciplinary team.

• Conducts and collaborates with others on the principles and theories of quantitative evaluation of new products and maintenance of existing pharmacokinetics and drug metabolism product lines through the application of state-of-the-art knowledge in pharmacokinetics and bioanalytical chemistry.

• May make decisions impacting clinical pharmacology goals and the success and relevance of individual clinical trials.

• Develops strategies in Phase 1 to ensure effective achievement of clinical and drug development objectives in R&D.

• Manages the design and preparation of clinical pharmacokinetics development strategies and study protocols, performing and supervising pharmacokinetics and pharmacodynamic studies and analyses, and preparation of clinical study reports and integrated summary documents.

• May provide feedback and direction for regulatory submissions preparation and review support for new or existing products. Works closely with clinical study management teams, biostatistics, data management, research and development, drug metabolism and therapeutics areas.

• Selects, develops and evaluates personnel to ensure the efficient operation of the function.


Qualifications

Education/Experience
• MD, or PhD or PharmD in life sciences/healthcare required
Experience
• 4-8+ years (Director), (2-3 years Associate Dir) of experience in the PK/PD, pharmaceutical, and/or biotech sectors
• 4-8+ years Director, (2-3 years Associate Dir) of clinical pharmacology or drug development experience, in an industry setting

Knowledge, Skills and Abilities

• Demonstrated strong leadership capabilities
• Demonstrated ability to interact internally and externally with sites, CROs, vendors, experts, and executive level management
• Demonstrated presentation skills
• Excellent communication skills; written and verbal


Working Conditions

Office Environment and some travel may be required.

NOTE: This job profile describes the duties and requirements of the position. Requirements stated are representative of minimum levels of knowledge, skills and/or abilities required to successfully perform the job. The employee may be asked to perform other job-related duties as required.

How to Apply

Application Instructions / Send a Resume