Job Description
Location: Watertown, MA (onsite)
Science/ Focus: Small Molecule
Job Overview: This role involves driving nonclinical safety strategies, overseeing scientific studies, ensuring regulatory compliance, and authoring regulatory safety documents for clinical development support.
Primary Job Responsibilities: - Drive the nonclinical safety strategy and execution of programs to assist in lead selection, candidate nomination and to fully support clinical development.
- Provide scientific leadership and oversight of all in vitro and in vivo nonclinical safety studies, including genetic and general toxicology, safety and secondary pharmacology, and developmental, reproductive and juvenile toxicology testing.
- Ensure nonclinical safety assessment studies are compliant with US FDA and OECD GLP regulations and with global nonclinical safety guidances and guidelines, maintaining up-to-date knowledge of evolving regulatory requirements.
- Author all nonclinical safety-relevant portions of regulatory documents, including pre-IND, IND and annual updates; IB and updates; DSUR and updates; PIP/PSP, as well as briefing booklets for US and ex-US regulatory meetings and filings.
Primary Job Requirements :
- DVM/PhD (highly preferred), DVM, or PhD in toxicology, pharmacology, or related field.
- 12+ years of experience in nonclinical safety assessment in the biotechnology, pharmaceutical, or CRO industries, with at least 5 years in a senior leadership role.
- Deep knowledge of genetic and general toxicology, safety and secondary pharmacology, DART and related regulatory requirements (e.g., FDA, EMA, ICH guidelines).
- Proven track record in the successful design, execution, and management of nonclinical safety programs.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
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