Job Description

Job Description

Job Description

Position Overview:
We are seeking an experienced scientific professional to provide expert leadership in the area of nonclinical safety to advance a pipeline of therapeutic candidates. This individual will play a key role in guiding project teams through preclinical development, working cross-functionally to support regulatory filings and strategic planning in both oncology and immunology programs.

Key Responsibilities:

• Serve as the lead safety expert across drug development programs, offering strategic input into the safety evaluation, prioritization, and progression of new molecular entities.

• Collaborate with external research organizations to commission and oversee safety-related lab studies (both in vitro and in vivo). Ensure studies are properly designed, executed, and reviewed.

• Provide detailed interpretation and summaries of safety data, ensuring timely and clear communication to internal teams and executive stakeholders.

• Support regulatory documentation and submission activities by drafting and reviewing nonclinical sections, including study summaries and risk assessments.

• Contribute to early- and late-stage development strategy by working closely with functions such as chemistry, pharmacology, CMC, regulatory, and clinical development.

• Stay current with evolving regulatory trends and toxicological best practices by engaging with scientific communities or participating in relevant forums.

• Conduct research-based evaluations of target safety during early discovery to inform go/no-go decisions and reduce potential risk early in the process.

Qualifications & Experience:

• Doctorate (Ph.D.) in toxicology, pharmacology, or a closely aligned discipline.

• Certification from the American Board of Toxicology (DABT) is strongly preferred.

• At least 15 years of postdoctoral experience, with a minimum of 10 years working in biotech or pharmaceutical industry settings. Final title (Director/Senior Director) will be based on depth and relevance of experience.

• Demonstrated expertise in regulatory toxicology and safety science, with prior experience in team representation on discovery and development projects. Background in immunology is a significant plus.

• Proven ability to analyze and synthesize diverse types of scientific data to support safety evaluations and identify potential risks.

• Hands-on experience in the design, execution, and interpretation of various toxicology studies, including general toxicology, safety pharmacology, and genetic toxicity.

• Familiarity with regulatory requirements and a successful track record of participating in regulatory interactions and submissions.

• Experience overseeing outsourced studies and managing relationships with contract research partners.

Core Competencies:

• Strong interpersonal and cross-functional collaboration skills.

• Prior leadership experience required for more senior-level consideration.

• Clear and effective verbal and written communication.

• Strong problem-solving mindset with scientific curiosity and a results-driven approach.

• Comfortable in fast-paced, high-growth environments.

• Detail-oriented and proactive with the ability to manage competing priorities.

Job Tags

Similar Jobs