Associate Director, Translational Toxicology – Preclinical

Wave Life Sciences

Lexington (MA)

On-site

USD 170,000 - 230,000

Full time

3 days ago

Be an early applicant

Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

Benefits offered by this job

Medical, dental, vision insurance

Paid time off with company shutdowns

401K with matching

Employee Stock Purchase Program

Job summary

Wave Life Sciences seeks a highly motivated professional to join the Preclinical and Clinical Development Sciences team in Lexington, MA. The candidate will lead safety assessment efforts for novel therapeutic oligonucleotides, shaping nonclinical regulatory documents and coordinating with regulators to support hepatic, kidney, muscular and CNS targets.

The role requires 7+ years in preclinical safety, GLP knowledge, and strong leadership within a cross-functional team.

Qualifications

7+ years in preclinical safety assessment of novel therapeutic entities.
Experience with regulatory submissions and responses.
Knowledge of GLP compliance and relevant ICH & FDA guidance documents.

Responsibilities

Support development as a primary representative of PCDS on Program Teams.
Coordinate between PCDS and other functions including CMC, Regulatory Affairs, Clinical Operations, and Platform and Discovery Sciences.
Provide risk assessment and de-risking strategies for discovery programs.
Design preclinical strategies for Discovery and Development candidate molecules.
Coordinate toxicity study design and monitor outsourced studies; integrate bioanalysis and toxicokinetics.