Contact: Mr. Peter J. Kratimenos
President
Peter J. Kratimenos Associates
PO Box 6037
Plymouth, MA 02360

Email: pk@kratimenos.com
Tel: 508-830-0079
Fax: 508-830-4627
URL: www.kratimenos.com

Senior Director, Toxicology

The selected candidate will actively participate on drug development teams, including toxicology program and study design, dosage selection, study initiation and monitoring, report review and finalization. Responsible for leading risk assessments and for regulatory interactions. Also responsible for literature reviews, critical evaluations of in-licensing opportunities, and data summaries and presentations. Determine toxicology studies needed to support development projects. Initiate studies at approved contract facilities following appropriate processes for protocol development, contract implementation, test article procurement, and timeline commitments. Monitor studies for accuracy and timely completion, and review draft reports for completion and consensus of opinions. Prepare verbal and written summaries of study reports for internal discussions and for regulatory submissions. Coordinate tasks across departments for efficiencies and synchronization to support team objectives. Anticipate problems and opportunities and raise issues and suggested resolutions to supervisor or appropriate team leader. Management of staff at multiple contract facilities must be carefully addressed in order to ensure the timing requirements of the internal project teams. Contributions to, and cross-functional review of, various regulatory documents requires careful time management, mature communication and diplomacy skills, and attention to continuing improvements in existing processes. Position may include supervisory responsibilities.

Requirements:
Ph.D. or equivalent in Toxicology, Pathology, Pharmacology, Chemistry, or related health science field. Board Certification (e.g. DABT, ACVP) desired but not essential. Ten or more years of experience in pharmaceutical non-clinical safety evaluation required, with at least 3 of those years including responsibilities for risk assessments, FDA interactions and project decision making. Working knowledge of GLP regulations, ICH guidance documents and experience conducting and monitoring toxicology studies essential. Strong oral communication skills and demonstrated proficiency at technical writing are essential. Working knowledge of drug metabolism and/or kinetics would be a plus. Demonstrated leadership/supervisory strengths desired. Extensive interactions across departments and external study monitoring responsibilities require solid time management and effective communication skills. This position requires an individual with excellent organizational, written and oral communication skills, high degree of self motivation, and effective problems solving skills in addition to time management, task management and mature communication and team skills are essential. As all studies are conducted externally, a fair amount of traveling (e.g. 10-20%) could be expected, depending upon project assignments.

Contact for confidential, immediate response:

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Mr. Peter J. Kratimenos
President
Peter J. Kratimenos Associates
PO Box 6037
Plymouth, MA 02360

Email: pk@kratimenos.com
TEL: 508-830-0079
FAX: 508-830-4627
URL: www.kratimenos.com
***Specializing In All Aspects of Technical Recruitment***
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