Pre-Clinical Director - San Diego, CA | Biospace
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Pre-Clinical Director

Xeris Pharmaceuticals, Inc.

Location:
San Diego, CA
Posted Date:
7/11/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Xeris is an emerging pharmaceutical company dedicated to the development of patient-friendly injectable drugs to address important unmet medical needs while improving patient compliance, lowering total costs of treatment, and having a positive impact on patient and caregiver quality of life. With this singular focus on patient quality of life, each member of the Xeris team is working to develop novel products that improve upon existing products or enable delivery of novel drug substances, allowing for treatments not previously possible.  

Position Summary

Xeris is looking for a Pre-Clinical Director to join our team in San Diego, CA.  The Pre-Clinical Director is responsible for evaluating project objectives and contributing scientific expertise into the design, implementation and validation of various in-vivo pharmacology and toxicology studies to support drug development programs and progression of Xeris development candidates.

Responsibilities

•   Identify existing rodent and non-rodent animal models at off-site CROs that can be utilized for testing of candidate drugs
•   Lead the selection of test facilities for conduct of studies
•   Prepare protocols, timelines and budgets for preclinical studies
•   Routinely report progress in a timely and concise manner to teams and Senior Management
•   Anticipate, identify, and work collaboratively to resolve issues affecting progression of studies
•   Prepare project timelines and monitor outsourced studies, critically review study results and report and approve study reports prior to finalization by the test facility
•   Work closely with internal research personnel and provide key interface between research and development
•   Interact with the R&D team to identify new indications and drug product concepts
•   Identify key bioanalytical CRO’s and manage outsourced bioanalytical programs adhering to GLP requirements
•   Model and predict human dose, pharmacokinetics and therapeutic window to support development decisions on candidate molecules
•   Prepare internal reports and nonclinical sections of regulatory documents
•   Maintain up to date knowledge of regulatory agency nonclinical/clinical pharmacology and toxicology regulations/guidelines
•   Participate in cross-functional development-team activities
•   Other responsibilities and duties as required


Requirements

•   A PhD in Pharmacology, Toxicology, or related area is required with at least 10 years of experience in design, planning, conduct, monitoring and reporting of pharmacology disease models, pharmacokinetics, toxicology, drug metabolism and/or clinical pharmacology
•   In depth knowledge of animal models of drug pharmacokinetics and safety
•   A solid understanding of statistical methods for evaluating in vitro and in vivo preclinical studies
•   Excellent communication skills, including the ability to speak, write and understand English to comply with written procedures, instructions, SOPs and other documents
•   Demonstrated problem-solving and organizational skills
•   A successful track record of leadership, project management, and cross functional teamwork
•   Must be detail-oriented, innovative and able to work in a hands-on manner within the team
•   A passion for working in a small, entrepreneurial and collaborative environment
•   Excellent time and fiscal management skills
•   Brings a wealth of experience in design and execution of animal studies and assessment of therapeutic candidates in these models
•   Has a deep understanding of non-clinical drug safety and associated regulation’s
•   Anticipates and solves technical problems