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.
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