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Director Preclinical Jobs (NOW HIRING)

TRIMAREN

Director, Preclinical Safety

Watertown, MA · On-site

At this critical stage, the organization is seeking a Director of Preclinical Safety to architect and lead the nonclinical safety strategy across a growing portfolio of assets. This is a foundational ...

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What are the key skills and qualifications needed to thrive in the director preclinical position, and why are they important?

To thrive as a Director Preclinical, you need in-depth expertise in drug development, toxicology, and pharmacology, typically supported by an advanced degree (PhD, PharmD, or DVM) and significant industry experience. Familiarity with preclinical study design, regulatory submission platforms (such as IND/CTA), and relevant quality management systems is vital. Strong leadership, strategic planning, and communication skills make candidates stand out for effectively managing multidisciplinary teams and partnerships. These competencies are critical for ensuring timely progress of drug candidates through preclinical stages while maintaining compliance and scientific rigor.

What are the typical responsibilities and team dynamics for a director preclinical?

As a Director Preclinical, you will oversee the planning, execution, and interpretation of preclinical research studies supporting drug discovery and development. This leadership role often involves managing cross-functional teams of scientists, project managers, and external partners such as contract research organizations (CROs). You will regularly collaborate with colleagues in regulatory affairs, clinical development, and senior management to align research objectives with overall company goals. The work environment is both strategic and hands-on, requiring frequent communication and the ability to facilitate problem-solving across departments. This role is ideal for professionals who enjoy leading scientific innovation while navigating the complex regulatory landscape of new drug development.

What does a director preclinical do?

A Director of Preclinical research oversees the early-stage development of drugs, medical devices, or therapies before human clinical trials begin. They manage preclinical studies, ensuring regulatory compliance, scientific rigor, and alignment with company goals. Responsibilities include designing research strategies, supervising laboratory teams, interpreting data, and collaborating with regulatory agencies such as the FDA. Their role is critical in assessing the safety and effectiveness of new treatments before advancing to human trials.

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Infographic showing various Director Preclinical job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 84% Full Time, 12% Part Time, 1% Temporary, and 2% Contract. Highlights an 92% Physical, 3% Hybrid, and 5% Remote job distribution.

Director, Preclinical Safety

TRIMAREN

Watertown, MA • On-site

Full-time

Medical, Dental

This job post has expired today. Applications are no longer accepted.

Job description

Confidential Biotech | Stealth Mode

Confidential Biotech | Stealth Mode We are partnering with a well-capitalized, stealth-stage biotechnology company that is building a differentiated therapeutic platform with the potential to address significant unmet needs. Backed by experienced leadership and institutional-grade investors, the company is advancing its programs toward IND with a deliberate, milestone-driven strategy. At this critical stage, the organization is seeking a Director of Preclinical Safety to architect and lead the nonclinical safety strategy across a growing portfolio of assets. This is a foundational role designed for a leader who can translate complex biology into a coherent safety framework, enabling confident progression from discovery through IND and beyond. The successful candidate will be a leader who brings both depth in toxicology and the judgment required to operate effectively in an early-stage, high-ambiguity environment. The Director will establish and execute integrated preclinical safety strategies across multiple programs, ensuring that toxicology and safety pharmacology efforts are scientifically rigorous, operationally disciplined, and aligned with regulatory expectations. For the right individual, this role offers meaningful scientific ownership and participation in long-term value creation. The Company is primarily an on-site organization that fosters a collaborative, culture-driven workplace and embraces flexibility when needed to support its employees.

Key Responsibilities
  • Architect and implement integrated preclinical safety strategies aligned to program-specific and portfolio-level development milestones.
  • Design, oversee, and interpret toxicology and safety pharmacology studies, leveraging both internal capabilities and external CRO partnerships.
  • Establish and manage a high-performing external network, including CRO selection, qualification, and ongoing oversight to ensure data integrity and regulatory compliance.
  • Lead the nonclinical safety components of regulatory submissions, including authorship and strategic input for INDs and future filings.
  • Identify and contextualize emerging safety signals, translating data into actionable risk assessments that inform program direction.
  • Partner cross-functionally with biology, clinical, and regulatory teams to ensure integrated decision-making across the development continuum.
  • Serve as a scientific leader and mentor, elevating rigor and capability across the organization as the team scales.
Requirements
  • DVM, Ph.D. or equivalent with board certification in a relevant field like veterinary pathology (ACVP).
  • 10-15+ years of experience leading preclinical safety strategy for IND-enabling programs.
  • Deep expertise in toxicology and safety pharmacology study design, execution, and interpretation.
  • Proven track record supporting regulatory submissions (IND and beyond).
  • Experience managing multiple programs in parallel, balancing speed with scientific rigor.
  • Strong external orientation, with experience overseeing and influencing CRO partners.
  • Leadership capability with a commitment to mentoring and developing scientific talent.
  • Comfort operating in a build environment, where infrastructure, process, and strategy evolve in real time
Compensation & Benefits

The Company prioritizes the holistic well-being of its employees by offering a comprehensive range of health and wellness benefits. From medical and dental coverage to mental health resources and discounts on healthy living programs, it is committed to supporting the health and well-being of its team members and their families.