Principal Scientist, Toxicology

PTC Therapeutics•Bridgewater, NJ

About The Position

PTC Therapeutics is a global commercial biopharmaceutical company committed to extending life’s moments for children and adults living with a rare disease. They cultivate an inclusive culture where everyone feels valued, respected, and empowered, welcoming candidates from all backgrounds. The Principal Scientist, Toxicology is responsible for the design and oversight of nonclinical safety studies of development candidates. This role involves independent planning, execution, and interpretation of these studies. The scientist will communicate relevant safety information within the organization and serve as a toxicology representative in interactions with Project teams, Collaborators, and Contract Research Organizations (CROs). The incumbent will also work cross-functionally with internal departments and external resources on nonclinical safety-related issues, ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs).

Requirements

Ph.D. in Toxicology or other related discipline.
A minimum of 7 years experience with progressively increasing responsibilities in a pharmaceutical, biotechnology or related environment.
Hands on experience with nonclinical safety studies.
Experience in the conduct of studies in compliance with Good Laboratory Practices (GLP).
Demonstrated and applied knowledge of US and international regulatory requirements for the conduct and design of nonclinical safety studies.
Demonstrated ability to write scientific documents and reports. These include, but may not be not limited to, protocols, reports, and regulatory documents/submissions.
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Nice To Haves

Diplomate of the American Board of Toxicology (DABT)
Experience with orphan diseases.

Responsibilities

Designs and oversees studies in support of the nonclinical development program for development candidate compounds.
Develops protocols and monitors studies, as well as reviews, revises, and issues reports required for the nonclinical program.
Writes/Prepares regulatory documents including Toxicology sections of briefing books, investigational new drug applications (INDs), and investigator brochures (IBs).
Acts as a toxicology representative in interactions with collaborators and contract research organizations.
Performs other tasks and assignments as needed and specified by management.