Primary responsibilities include all aspects of preclinical development including the design, execution, management and regulatory submissions of all non-clinical safety studies during the course of preclinical development and clinical development of the company’s drug development programs. You will:

·         Plan and design all nonclinical studies, including non-GLP and GLP studies (safety pharmacology and toxicology studies), primarily through contract research organizations (CROs);

·         Manage the budget for non-clinical safety studies;

·         Manage contracts and coordinate activities with CROs; Serve as study monitor;

·         Prepare study reports and regulatory documents, including investigator’s brochures, INDs and NDAs;

·         Contribute to and participate in meetings and interactions with regulatory agencies;

·         Work closely with other functional areas such as Biology, Medicinal Chemistry, DMPK, CMC and Clinical;

·         Provide strategic preclinical expertise to cross-functional project teams as the in-house preclinical expert.

Qualifications / Experience:

·         Demonstrated expertise in nonclinical study design and management with small molecule drug candidates;

·         Demonstrated track record of successful regulatory filings;

·         Excellent understanding and experience in PK/TK studies;

·         Excellent track record in successful  contracting and managing safety studies with reputable CROs;

·         Ph.D. in toxicology, pharmacology, physiology, biology, or related discipline. DABT preferred but not required;

·         Minimum of 10 years of preclinical safety experience in the pharmaceutical/biotechnology industry experience;

·         Experience with pre-IND through Phase 1-3 programs and associated regulatory filings;

·         Experience in interacting with U.S. and European regulatory authorities in person, by teleconference and in correspondence;

·         Experience in interacting with corporate partners in person, by teleconference and in correspondence;

·         Highly motivated; well organized; multi-tasking;

·         Strong critical thinking and analytical skills;

·         Excellent communication and presentation skills;

·         Excellent team management skills