Associate Director / Director, Toxicology

Location
Cambridge, MA, US
Posted
Aug 26, 2020
Ref
1045
Discipline
Science/R&D, Toxicology
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Overview

Black Diamond Therapeutics is a next-wave cancer precision medicine company. Black Diamond is pioneering the development of selective medicines for patients with genetically defined cancers driven by oncogenes activated by allosteric mutations. Using its mutation, allostery and pharmacology (MAP) computational and discovery platform, Black Diamond is uncovering new ways to functionally assess the mutational landscape of individual oncogenes - to discover and validate new targets and develop novel approaches to creating highly selective therapeutics.

Black Diamond is currently seeking a Toxicology project lead with postgraduate training in toxicology or related discipline and preferably board-certified in general toxicology (DABT) and/or pathology (DACVP). Reporting to the VP Preclinical Development, the incumbent will be the toxicology and safety pharmacology lead on project teams developing small molecule modulators as precision cancer medicines. We are looking for a consummate team player seeking a collaborative environment in which to grow their career in drug development.

Responsibilities
  • In partnership with functional/project leaders, set the preclinical/regulatory toxicology strategy and plans for Black Diamond's programs in late discovery and early development.
  • Establishment and oversight of activities at CROs, including non-GLP pilot toxicity studies and GLP toxicology studies to support development of multiple drug candidates.
  • Be the functional area representative for Toxicology on project teams; collaborate with medicinal chemistry and CMC to ensure synthesis, formulation, and delivery of test articles for use in toxicology studies. Collaborate with DMPK in the design and integration of DMPK activities into toxicology studies.
  • Design, analyze and interpret preclinical toxicology studies in support of program goals, in an individual contributor role.
  • Author and review study reports and prepare relevant sections of regulatory documents, including pre-IND packages, INDs, clinical trial applications (CTAs), Investigator Brochures, special protocol reviews, regulatory Briefing Documents and NDAs/MAAs.

Qualifications
  • An advanced degree and 7-10+ years of experience in the biotech/pharmaceutical industry, with a focus in toxicology, pathology, safety pharmacology or related discipline. DABT or DACVP preferred.
  • Previous experience in managing nonclinical toxicology/safety programs, and design, execution, and regulatory reporting of GLP toxicology and safety pharmacology studies is required. Experience in drug development and regulatory submissions, including IND/CTA is desired.
  • Technical depth and a broad understanding of preclinical safety assessment, preferably with experience in oncology.
  • Experience leading Toxicology programs on projects from late discovery through development.

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs.

Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.