Sr. Principal Scientist Toxicologist

1 Legacy, Inc; Framingham (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Preclinical Safety Project Team Representative in Framingham, Massachusetts. The role involves providing scientific expertise in Toxicology and Safety Pharmacology for drug discovery and development. Candidates must have a PhD or DVM, along with strong experience in biotherapeutics development and regulatory document preparation. This position requires collaboration with various functions and adherence to scientific standards.

Qualifications

• PhD or DVM required; post-doctoral experience preferred.
• 6-8 years of relevant industry experience.
• Knowledge of regulatory nonclinical testing requirements.
• Knowledgeable about GLP policies and regulatory nonclinical testing requirements.
• Preparation of regulatory documents for submission to health authorities.

Responsibilities

• Serve as Preclinical Safety Project Team Representative.
• Design and coordinate nonclinical safety strategies.
• Prepare and review written preclinical safety reports.
• Act as internal biotherapeutics expert for nonclinical safety issues.
• Collaborate with Pharmacology, Regulatory Affairs, Clinical and Project Leaders daily.
• Participate in department-wide activities and inter-industry working groups.

Skills

Development of biotherapeutics

GLP policies knowledge

Interdisciplinary collaboration

Scientific expertise in Toxicology

Education

PhD or DVM

Post-doctoral experience

Post-doctoral experience

Job description

This position will provide Preclinical Safety a wide range of support associated with Toxicology and Safety Pharmacology needs on Discovery and Development Project Teams for Group projects. This position would provide scientific expertise across the drug discovery and development value chain on biotherapeutics and small molecules.

• Serve as Preclinical Safety Project Team Representative on multi-disciplinary Discovery and Development teams responsible for the progression of both biotherapeutics and small molecule drug candidates for regulatory submissions. These activities include designing and coordinating a multi-disciplinary effort to support such projects through the development of the nonclinical safety strategy and program including, but not limited to attending various project team meetings; design and interpretation of toxicity studies; preparation and/or review of written preclinical safety reports; and authoring of the nonclinical document sections for regulatory submissions.
• Serve as internal biotherapeutics expert for scientific issues related to nonclinical safety issues related to the development of these molecules.
• Interact with multiple functions (Pharmacology, Regulatory Affairs, Clinical, Project Leaders & Managers, etc.) on a daily basis.
• Involved with the multiple Community of Practice groups in preclinical safety and provide input to address safety issues; including design and conduct of investigative studies in support of the toxicological evaluation of compounds.
• Participate in Preclinical Safety Department activities (staff meeting, scientific forums, etc.), and special projects.
• Participate in special projects or inter-industry working groups, as needed. Provide scientific input on design and analysis of research activities.
• Ensure high scientific standards and adhering to requested timelines in all aspects of the position.

Qualifications

• PhD or DVM and post-doctoral experience.
• Experience in development of biotherapeutics is required.
• 6-8 years of relevant industry experience.
• Knowledgeable about GLP policies and/or regulatory nonclinical testing requirements for pharmaceutical development of biotherapeutics and small molecules.
• Preparation of regulatory documents for submission to health authorities.