Principal Scientist, Toxicology

PTC Therapeutics, Inc.•Bridgewater, NJ

20h•$165,000 - $185,000

About The Position

The Principal Scientist, Toxicology is responsible for the design and oversight of nonclinical safety studies of development candidates. The Principal Scientist works independently to plan, execute and interpret nonclinical safety studies. He/she will interact within the organization to communicate relevant safety information and act as a toxicology representative in interactions with Project teams, Collaborators, and Contract Research Organizations (CROs). The incumbent works cross-functionally with internal departments and external resources on nonclinical safety-related issues. The Principal Scientist, Toxicology has a thorough knowledge of and ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

Ph.D. in Toxicology or other related discipline and 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 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.