Global Safety Pharmacology

Where

Groton, CT

What you'll be doing

Perform all regulatory responsibilities in compliance with applicable regulatory standards. Responsible for the scientific oversight of investigative, screening or technology-based labs and assays to assure scientific credibility, quality, and data integrity. Manage a team of 5 direct reports with responsibility for global performance management functions, mentoring and training staff; contribute to GSP-wide talent planning and management. Scientific and document review of reports for exploratory, mechanistic, screening and GLP studies when results pertain to lead specific area of expertise; scientific input into protocols and study design for CVMED RU studies. Contribute to due diligence assessments. Provide subject matter expertise, scientific training, oversight and/or mentoring to study directors, investigative teams, laboratory personnel. Responsible for developing strategic plans for the laboratory, identification of new methods and technologies, development/monitoring of strategic alliance projects with external investigators. External influence activities e.g. publications, presentations, professional societies, planning symposia, cross industry collaborations, review of draft regulatory guidances (ICH, FDA, CHMP). Developing new technologies, assays, screens, etc. Participating in cross-function activities (e.g. Councils, Scientific Boards, Practice networks, etc.).

What your background should be

Appropriate board certification preferred (e.g. DABT, DACVP or other specialty). Prior experience in a preclinical safety and/or efficacy assessments, experience with disciplines relevant to CVMED RU desirable (for example, endocrinology, cardiovascular structure and function, vascular biology, renal physiology, metabolic disorders). Prior publications and presentations in specialty area. Identifies and develops scientific strategies to support longer term goals and set direction and strategy for CVMED discipline and GSP broadly. Excellent team skills. Able to work with colleagues at all levels, including those at remote sites. Able to stimulate and challenge colleagues scientifically. Able to develop a research plan to address safety related issues making use of emerging technologies. Needs to develop plans to address current and future portfolio challenges. Able to be future looking. Required to make complex decisions and troubleshoot in ambiguous situations with very high uncertainty of successful outcome for some of solutions attempted.

Required Schooling / Training

MSc/BSc biological sciences. PhD in pharmacology preferred.

Who is the client company

This is a leading research-based biopharmaceutical company.

If you are interested in this position, send your resume to apply@kochdavis.com