Contract Director, Nonclincial Safety & Pharmacokinetics, (1 year contract, full-time, onsite)

Director, Nonclinical Safety & Pharmacokinetics

📍 Cambridge, MA | On-site | Full-time

Pinetree Therapeutics

Pinetree Therapeutics is a rapidly growing biotechnology company developing next-generation biologics and bispecific antibodies in oncology and immune modulation. With multiple IND-enabling programs advancing toward the clinic, we are building a highly collaborative, science-driven environment focused on translating novel discovery concepts into transformative therapies for patients.

We are seeking a Director of Nonclinical Safety and Pharmacokinetics to lead preclinical safety and PK strategy and execution across Pinetree’s biologics portfolio. This is a hands-on, on-site leadership role based in Cambridge, MA, suited to a scientifically rigorous and execution-oriented professional eager to shape the company’s nonclinical development platform.

Key Responsibilities

• Nonclinical Strategy & Leadership: Lead, design, and implement nonclinical safety and PK strategies supporting Discovery and IND-enabling development for biologics and bispecific antibody programs. Serve as the nonclinical lead on cross-functional program teams.
• Study Oversight: Design, oversee, and interpret GLP and non-GLP toxicology and safety pharmacology studies conducted at CROs. Ensure scientific integrity, data quality, and adherence to regulatory and internal standards.
• Regulatory Contributions: Author and review nonclinical and PK sections of INDs, CTAs, and related regulatory documents. Participate in FDA and global health authority meetings.
• Cross-Functional Collaboration: Work closely with Discovery, Bioanalytical, PK/ADA, CMC, Clinical, and Program Management teams to align nonclinical and translational strategies and ensure assay readiness for PK and ADA.
• Innovation & Quality: Evaluate and implement New Approach Methodologies (NAMs) to strengthen translational predictivity. Lead continuous improvement initiatives, including SOP development, impurity/excipient risk assessments, and CRO performance oversight.
• Leadership & Mentorship: Mentor junior scientists and drive cross-functional collaboration to meet program milestones and ensure high-quality, timely data delivery.

Qualifications

• PhD, DVM, or equivalent in toxicology, pharmacology, or related discipline (board certification DABT, DACVP, or ERT preferred).
• 8–12 years of experience in nonclinical safety and PK within biotech or pharma, including GLP study oversight and regulatory submissions.
• Strong knowledge of biologics development, PK/PD integration, GLP/ICH M3(R2), and FDA/EMA expectations for IND submissions.
• Demonstrated ability to lead scientifically complex programs and collaborate effectively in a small, entrepreneurial company setting.
• Excellent technical writing, data interpretation, and communication skills.

Additional Information

This contract could be extended or changed to FTE depending on business needs and performance.

• Location: Cambridge, MA (on-site presence required)
• Therapeutic Focus: Biologics and immuno-oncology
• Travel: Up to 10% (domestic and international)
• Core Strengths: Strategic and hands-on leadership, scientific rigor, adaptability, and operational excellence in preclinical drug development

If you’re ready to lead nonclinical strategy and help drive first-in-class biologics toward the clinic, we’d love to hear from you.

👉 Apply now to join Pinetree Therapeutics in Cambridge, MA.

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.