Our pharmaceutical client here in MA and laboratories in the mid-west is growing and looking to hire a Sr. Scientist, Investigational Toxicology – De-risking (REMOTE) to their growing team! This newly created role will provide scientific input, program management and toxicology support to Nonclinical activities across the company’s R&D pipeline (small molecule/oncology). This position will report to the Senior Director, Nonclinical R&D, Toxicology, ADME/DMPK and can work remotely with travel to their research facility in the mid-west. Responsibilities include but are not limited to:
- Ensures scientific and operational excellence across the toxicology and safety pharmacology activities.
- Collaborates closely with Nonclinical R&D Team, consultants, and external CRO partners to ensure studies are fit for purpose, completed on time, on budget and meet quality standards.
- Contribute to writing and editing nonclinical safety study research reports to support regulatory filing including pre-IND, IND, IND annual updates, IB, as well as relevant sections to support US and International regulatory filings.
- Track and manage timelines for Nonclinical R&D studies across various stakeholders identifying interdependencies, milestones, and risks.
- Align internal business needs and expectations with external CRO partners.
- Ensure compliance with global non-clinical safety studies regulatory guidelines.
- Ensure completion of non-clinical safety studies to support program timelines and goals.
Requirements:
- Ph.D. in Toxicology or related field and 5+ years of toxicology experience in the pharmaceutical industry.
- Experience in investigational toxicology safety assessment of small molecules in discovery.
- Demonstrated knowledge and full understanding of GLP regulatory requirements, Standard Operating Procedures (SOPs), company practices, and industry standards.
- Ability to apply project management principles including, but not limited to, identifying critical paths, building and communicating timelines, defining milestones and methods for setting expectations and accountability for deliverables within Non-Clinical R&D functions.
- Strong functional knowledge and experience of Toxicology, ADME/DMPK, Formulation & Analytical, and Bioanalytical workflows.
- Strong leadership competencies and management experience, including selecting CROs and overseeing the relationship.