Director, Nonclinical / Toxicology Project Lead (1-Year, Full-Time, On-Site)
About the Company
PineTree Therapeutics is an innovative biotech company pioneering multispecific degrader antibodies to revolutionize cancer treatment. Our proprietary platform is designed to target and degrade membrane-bound and extracellular proteins, offering a new approach to overcoming drug resistance in oncology. We are advancing a robust preclinical pipeline and actively preparing for translational and early clinical development.
Job Description
This strategic leadership role guides nonclinical safety and PK assessments from discovery through IND/CTA submissions, ensuring alignment with regulatory and scientific standards. The Director acts as the toxicology lead on cross-functional project teams and provides technical and strategic expertise for safety pharmacology, toxicology and PK and will be responsible for implementing the New Approach Methodologies (NAMs) data recently announced by the FDA.
Duties and Responsibilities
Additional Details
Location:
Full-time, on-site position at PineTree Therapeutics, Cambridge, MA.
Contract Duration:
1 Year (with potential for extension based on performance and business needs).
What We Offer
We seek candidates with a passion for building a creative company culture that is collaborative, multidisciplinary, and committed to make a transformative impact to our industry. To be successful in this role, we look for passion in scientific innovation, adept business skills, and excitement about working in a dynamic startup environment. A demonstrable track record of success in functioning as part of a project team is essential. Pinetree Therapeutics offers highly competitive salaries and comprehensive benefits, including medical and dental insurance, paid time off, and 401(k) with a generous company match.
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.
About the Company
PineTree Therapeutics is an innovative biotech company pioneering multispecific degrader antibodies to revolutionize cancer treatment. Our proprietary platform is designed to target and degrade membrane-bound and extracellular proteins, offering a new approach to overcoming drug resistance in oncology. We are advancing a robust preclinical pipeline and actively preparing for translational and early clinical development.
Job Description
This strategic leadership role guides nonclinical safety and PK assessments from discovery through IND/CTA submissions, ensuring alignment with regulatory and scientific standards. The Director acts as the toxicology lead on cross-functional project teams and provides technical and strategic expertise for safety pharmacology, toxicology and PK and will be responsible for implementing the New Approach Methodologies (NAMs) data recently announced by the FDA.
Duties and Responsibilities
- Nonclinical Safety and PK Leadership: Lead development and execution of safety and PK strategies; serve on cross-functional project teams.
- New Approach Methodologies (NAMs): Lead development, implementation and execution of NAMs
- Study Oversight: Design, manage, and interpret safety pharmacology and toxicology studies (GLP/non-GLP).
- Regulatory Contributions: Author/review regulatory documents (INDs, CTAs, NDAs, BLAs, etc.); represent the company in regulatory interactions.
- Cross-functional Collaboration: Interface with Discovery, Bioanalytical, PK, Clinical, CMC, and Program Management teams.
- Strategic Input: Evaluate CROs, resolve safety issues, manage impurity/excipient risk assessments, contribute to SOPs and department improvements.
- Team Management: Lead and mentor scientific staff; oversee project goals and development milestones.
- Therapeutic Areas: Emphasis on biologics molecules in oncology and other indications.
- Education: PhD, DVM, or equivalent in toxicology/pharmacology; DABT/DACVP/ERT preferred.
- Experience: 10+ years in nonclinical safety (study design, regulatory submissions, leadership).
- Expertise: GLP, ICH, FDA/EMA regulatory expectations, PK/PD, safety assessment, and translational pharmacology.
- Skills: Strong leadership, strategic thinking, technical writing, data interpretation, regulatory authorship, and cross-functional communication.
Additional Details
- Travel: Up to 10%, domestic and international.
- Key Strengths: Critical thinking, adaptability, collaborative mindset, mentoring capability, and operational excellence in drug development.
Location:
Full-time, on-site position at PineTree Therapeutics, Cambridge, MA.
Contract Duration:
1 Year (with potential for extension based on performance and business needs).
What We Offer
- Opportunity to be at the forefront of oncology research, contributing to the development of next-generation cancer therapies.
- A collaborative, supportive, and inclusive work environment where innovation thrives, and career development is encouraged.
- Competitive compensation package, including comprehensive benefits and opportunities for professional growth.
We seek candidates with a passion for building a creative company culture that is collaborative, multidisciplinary, and committed to make a transformative impact to our industry. To be successful in this role, we look for passion in scientific innovation, adept business skills, and excitement about working in a dynamic startup environment. A demonstrable track record of success in functioning as part of a project team is essential. Pinetree Therapeutics offers highly competitive salaries and comprehensive benefits, including medical and dental insurance, paid time off, and 401(k) with a generous company match.
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.
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