Head of Preclinical Safety (Job Code #HPS)

FLX Bio is seeking a talented scientist familiar with preclinical safety and toxicological assessments of small molecules. This position will be responsible for designing and executing non-GLP and GLP safety assessments of FLX Bio’s portfolio of preclinical development assets.

 

Position Description

This individual will design strategies and work-flows for safety assessments from the drug discovery to clinical candidate stage.  During the drug discovery phase this position will be responsible for coordinating early in silicoand in vitrotoxicology evaluations on promising molecules.

  • Evaluate and strategically implement established in vitro toxicology assays and in silicotools that support drug discovery
  • Provide accurate interpretation of results
  • Participate in the selection of development candidates with improved chances of being successfully progressed into clinical development

 

When the preclinical candidate has been selected, she/he will play a leading role the IND-enabling studies.

  • Establish and implement strategies for the nonclinical safety pharmacology and toxicology evaluation of development programs
  • Using internal facilities and external CROs for higher species, oversee studies to determine doses for the GLP study
  • Identify and oversee the CROs to carry out an appropriate in vitroand in vivo GLP toxicology program
  • Work with consultants as needed to explore specific issues
  • Interpret all safety pharmacology and toxicology/toxicokinetic study data and manage CROs to complete accurate and representative final study reports
  • Establish safety margins to inform the clinical and regulatory strategy
  • Take a primary role in writing the nonclinical sections of INDs, IB’s and other regulatory documents
  • Assemble and edit non-clinical safety assessment documents to fulfill regulatory requirements (e.g. Investigational New Drug Applications (INDs), Investigational Brochures (IB), Regulatory Briefing Documents, Common Technical Documents (CTD)) in support of the New Drug Application (NDA) in the US and Market Authorization Applications (MAA) in the EU
  • Attend face-to-face and teleconference meetings with regulatory agencies if needed

 

Represent the Preclinical Development/Toxicology perspective at FLX

  • Set high standards of excellence in toxicological science
  • Participate/Lead Preclinical development teams to advocate toxicology perspective
  • As a member of the expanded management team identify and solve key issues important to preclinical development at FLX

 

The successful candidate will contribute to a fast paced and energetic environment that both recognizes individual contributions but also strongly values a vibrant and collaborative team environment. They will demonstrate a sense of urgency in meeting aggressive, time-sensitive goals.

 

Key Qualification Include

 

Ph.D. in Toxicology or Related Science; DABT preferred

 

5+ years of industrial experience in conducting IND enabling toxicological studies with small molecules

 

Consistent track record of delivering successful toxicology packages and regulatory documents that have facilitated multiple clinical trials

 

Excellent leadership, and problem-solving skills. Team player with strong mentoring skills

 

Excellent written and communication skills

 

Other qualifications could include

 

Familiarity with pharmacokinetic studies and their analysis.

 

Familiarity with in vitro and in silico predictions of PK and ADMET properties.