Head of Translational Science and Preclinical Pharmacology

Location
South San Francisco, California
Salary
TBD
Posted
Jun 08, 2018
Hotbed
NextGen Bio
Required Education
Doctorate/PHD/MD
Position Type
Full time

Surrozen is seeking a Head of Translational Sciences and Preclinical Pharmacology who is a highly experienced large molecule drug discovery professional with an outstanding track record. This position is responsible for planning and implementing all non-clinical studies including drug exposure, efficacy and toxicology studies across species. This position will work collaboratively with internal cross-functional teams and with consultants or potential external resources to plan and execute an overall development strategy for candidate molecules progressing from discovery research to clinical development.  A background in regenerative medicine is highly desirable and a proven ability to deliver large molecule therapeutics into the clinic is essential.

 

Key Responsibilities

  • Lead and identify multiple disease indications and establish specific in vivo models for those disease indications
  • Design, execute, and interpret nonclinical studies conducted in multiple species under non-GLP and GLP conditions
  • Ensure all preclinical development activities are conducted in line with regulatory standards and guidelines
  • Provide scientific leadership in all aspects of Surrozen’s preclinical development programs from early in vivo characterization to IND-enabling studies
  • Lead and work with CROs in assessing PK, PK/PD, target engagement, biomarkers, and toxicology, and establish the safety profile for preclinical development
  • Oversee collaborations with academic investigators or industry partners; work with key opinion leaders in specific disease areas
  • Generate comprehensive reports that assess the pharmacologic/toxicologic profile of drug candidates, and investigate toxicity relationships
  • Present analyses and interpretations of studies to regulatory agencies in meetings and documents including IND, annual reports, investigator brochures, special protocol assessments and market applications
  • Develop strong transparent relationships across the organization and collaborate with the large molecule process development team to deliver preclinical studies
  • Develop, mentor and guide a top-level, highly effective team
  • Contribute to clinical trial design
  • Manage and develop strategies to partner with regulatory agencies

Requirements

 

  • PhD or MD with at least 10 years of drug discovery/drug development experience, applied pharmacology or clinical practice
  • Strong knowledge of disease and injury models and current clinical treatments
  • Hands-on experience taking biologics through preclinical development into the clinic
  • Knowledge of, and experience complying with, the regulatory requirements of operating an in vivo facility and managing various preclinical and toxicological studies
  • Strong interpersonal skills and proven ability to work effectively in a multidisciplinary team environment
  • Strong leadership, people development, and influencing skills