Principle Scientist, Toxicology

Pinetreetx; Cambridge (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

A leading biotech company is seeking a Principal Scientist in Toxicology to drive nonclinical safety evaluations for drug development. The role involves designing and overseeing safety strategies, managing project teams, and ensuring compliance while making impactful decisions to advance their therapeutic pipeline.

Benefits

Competitive salary and bonus program

Comprehensive health, dental, and vision insurance

401(k) plan with company matching

Stock options/equity participation

Opportunities for professional growth

Qualifications

• 5-10 years of experience in toxicology with demonstrated impact.
• Experience as a study director or similar role in toxicology.
• Proven success in authoring regulatory documents.

Responsibilities

• Lead nonclinical safety evaluation activities for drug discovery.
• Design and oversee toxicology strategies and studies.
• Collaborate with cross-functional teams to ensure patient safety.

Skills

Leadership

Cross-functional collaboration

Communication

Regulatory toxicology

Project management

Education

PhD in Toxicology

DVM or PharmD in a related life sciences discipline

Job description

5 days ago Be among the first 25 applicants

Direct message the job poster from PineTree Therapeutics Inc

Job Title: Principal Scientist, Toxicology

Location: Cambridge, MA

Department: Preclinical Safety Assessment

Reports To: Executive Director, Preclinical Development

About Pinetree Therapeutics

Pinetree Therapeutics is an innovative biotechnology company focused on developing transformative therapies for patients with serious diseases. We are committed to scientific excellence, cross-functional collaboration, and advancing a robust pipeline of biologics from discovery through clinical development.

Position Summary

We are seeking a Principal Scientist, Toxicology to lead nonclinical safety evaluation activities supporting drug discovery and development across multiple therapeutic areas. This role is critical to the success of our pipeline and involves designing and overseeing toxicology strategies, studies, and regulatory submissions for large molecule programs and other modalities.

You will serve as the Nonclinical Safety Project Team Representative, collaborating with discovery, translational, regulatory, and clinical development colleagues to support informed decision-making and ensure patient safety.

Key Responsibilities

• Serve as the toxicology subject matter expert on cross-functional project teams.
• Design and oversee nonclinical safety assessment strategies for bispecific antibodies and other modalities.
• Lead the planning, conduct, monitoring, and interpretation of GLP and non-GLP in vivo and in vitro toxicology and safety pharmacology studies.
• Evaluate, interpret, and integrate toxicology, pharmacokinetic, and pathology data to support program progression.
• PK, PK/PD, and or modeling experience/familiarity a plus
• Develop and review relevant sections of regulatory submissions (IND, CTA, BLA, NDA, etc.).
• Collaborate with CROs to manage study execution in compliance with GLP and animal welfare guidelines.
• Lead mechanistic investigations into observed toxicities and propose risk mitigation strategies.
• Represent Pinetree in regulatory interactions and contribute to health authority responses.
• Stay current with advances in toxicology, emerging regulatory expectations, and innovative methodologies.

Qualifications

Education:

• PhD, DVM, or PharmD in Toxicology, Pharmacology, or a related life sciences discipline.

Experience:

• Minimum of 5–10 years of industry experience in toxicology, with demonstrated impact across development stages.
• Experience serving as a study director or monitor for general toxicology and/or safety pharmacology studies.
• Proven success in authoring regulatory documents and interacting with global regulatory agencies.
• Board certification (e.g., DABT) is preferred.

Skills:

• Deep understanding of regulatory toxicology and drug development paradigms.
• Strong leadership and cross-functional collaboration skills.
• Excellent written and oral communication, with ability to translate complex scientific concepts to broad audiences.
• Familiarity with major species used in toxicology testing (primarily NHPs and rodents).
• Ability to manage multiple projects, prioritize tasks, and influence decision-making processes.

What We Offer

• Competitive salary and bonus program.
• Comprehensive benefits including health, dental, and vision insurance
• 401(k) plan with company matching.
• Stock options/equity participation.
• Opportunities for professional growth and development in a dynamic biotech environment.

Pinetree is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Pinetree will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Recruitment & Staffing Agencies: Pinetree does not accept unsolicited resumes from any source other than candidates. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Pinetree, and Pinetree will not owe any referral or other fees with respect thereto.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Biotechnology

Referrals increase your chances of interviewing at PineTree Therapeutics Inc by 2x

Get notified about new Principal Scientist jobs in Cambridge, MA.

Principal Scientist , Analytical Science Lead

Senior Scientist, Synthetic Enabling Technologies

Cambridge, MA $100,500.00-$145,166.66 4 days ago

Cambridge, MA $156,000.00-$296,500.00 2 weeks ago

Senior Scientist, Analytical Development (Chemistry).

Principal Scientist - Small Molecule Process Development

Greater Boston $104,900.00-$140,100.00 3 weeks ago

Scientist/Senior Scientist, Chemical Development and Manufacturing

Research Associate/Scientist – Physical Vapor Deposition

Principal Scientist, Drug Product Development

Cambridge, MA $149,858.00-$185,119.00 4 hours ago

Senior Principal Scientist, Translational Development, Pancreatic Cancer Disease Lead

Scientist 3/Senior Scientist, Clinical Pharmacology

Principal Research Scientist II, Analytical Development ( On-site, Waltham MA)

Waltham, MA $137,500.00-$261,000.00 2 days ago

Senior Principal Research Scientist, Analytical Chemistry

Cambridge, MA $156,000.00-$296,500.00 2 weeks ago

Senior Scientist Translational Gene editing Development with AAV, Gene and Cell Therapeutics Platform Research Organization

Principal Scientist/Director, Bioanalytical Chemistry

Senior Principal Research Scientist, Physics-Based Methods Development

Cambridge, MA $119,700.00-$270,400.00 1 week ago

Senior Behavioral Scientist, Nudge Unit, Behavioral Insights & Strategic Research

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.