Preclinical Toxicologist or Toxicological Pathologist

Location
Lexington, Massachusetts (US)
Posted
Jul 02, 2018
Discipline
Science/R&D, Toxicology
Required Education
Doctorate/PHD/MD
Position Type
Full time

Wave Life Sciences USA seeks a highly-motivated individual to join the Preclinical Development team in Lexington, Massachusetts. The candidate will be expected to provide scientific expertise and leadership across the portfolio by contributing to the safety assessment of novel therapeutic oligonucleotides intended for the treatment of rare diseases. The candidate should possess an in-depth understanding of toxicology and/or toxicologic pathology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies. Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is required. A background in neurochemistry, neuroanatomy and the safety assessment of drugs intended to treat diseases of the nervous system is a plus.

Responsibilities:

This position will be part of the Preclinical Development (PCD) team supporting early development in multiple areas including toxicology, DMPK, BA, and pharmacology, as a primary representative of PCD on Program Teams and in collaboration and interaction with other functions in multiple development programs. This position will also play a key role in managing studies at CROs and academic labs.

  • Design preclinical (safety pharmacology and toxicology) aspects for pre-candidate selection and development programs
  • Represent PCD at team meetings and coordinate between PCD and other functions including Bioanalytical, CMC, Regulatory Affairs, Clinical, and Discovery
  • Design toxicity studies; coordinate with Preclinical Outsourcing for placement and monitoring of the studies as well as the Bioanalytical group regarding integration of bioanalysis and toxicokinetics into these studies
  • Work with the Senior Director of PCD to manage the departmental budget
  • Work with the Preclinical Outsourcing Lead to place nonclinical studies and to manage all aspects of these studies to ensure on-time delivery of key data and study reports

If the incumbent is a toxicologic pathologist additional responsibilities may include:

  • Diagnose and interpret compound-related effects in animals including assessment of cause of death, target organs of toxicity and reversibility of toxicity by
  • Providing expert primary pathology reads on exploratory toxicity studies
  • Serve as the Peer Review Pathologist supporting GLP compliant toxicity studies performed at CROs
  • Work with research project teams to utilize and interpret animal models of diseases for efficacy assessment and PK/PD evaluation
  • Manage toxicologic pathology related program-specific plans and timelines

Education / Experience:

  • PhD in biology, toxicology or related field and/or DVM
  • Board certification in toxicology and / or pathology is highly desirable
  • 5+ years in preclinical safety assessment of novel therapeutic entities
  • Experience in any of the following areas is a plus: neuropathology, therapeutic oligonucleotides
  • Knowledge of GLP compliance and relevant ICH & FDA guidance documents
  • Experience in interfacing a preclinical function with QA, Regulatory Affairs, CMC, and Clinical functions
  • Outstanding interpersonal skills and verbal and written communication skills
  • Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment
  • Ability to work well with external CROs and collaborators with professionalism and discretion
  • Ability to travel to monitor out-sourced studies
  • Outstanding organizational skills/ability to prioritize and deliver in timely fashion