Principal Scientist, Toxicology

PTC Therapeutics, Inc; Bridgewater (MA); On-site; USD 165,000 - 185,000; Full time

Job summary

PTC Therapeutics, Inc. is seeking a Principal Scientist, Toxicology to oversee nonclinical safety studies for development candidates. You will design, execute, and interpret studies and communicate safety information across teams, including CROs and collaborators.

The role requires a Ph.D. in Toxicology with at least 7 years' experience, GLP familiarity, and strong regulatory writing skills. Collaboration across functions and a fast-paced environment are expected.

Qualifications

• Ph.D. in Toxicology or related discipline with 7+ years' experience in pharma/biotech.
• Hands-on experience with nonclinical safety studies and GLP.
• Knowledge of US and international regulatory requirements for nonclinical safety studies.
• Ability to write protocols, reports, and regulatory documents.

Responsibilities

• Designs and oversees nonclinical safety studies to support development candidate programs.
• Develops protocols, monitors studies and reviews reports for the nonclinical program.
• Writes regulatory documents including Toxicology sections of briefing books, INDs, IBs.
• Acts as toxicology representative in interactions with collaborators and CROs.
• Performs other tasks as needed by management.

Skills

Nonclinical safety studies

GLP compliance

Regulatory requirements knowledge

Scientific writing

Communication skills

Education

Ph.D. in Toxicology

Tools

Microsoft Office

Job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture! Website: www.ptcbio.com

Job Description Summary

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.

ESSENTIAL FUNCTIONS

Primary duties/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.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum level of education and years of relevant work experience

• 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.

Special knowledge or skills needed and/or licenses or certificates required

• 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.

Special knowledge or skills and/or licenses or certificates preferred

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

Travel requirements

• 10-25%

Expected Base Salary Range

$165,000 - $185,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.

EEO Statement

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.