Toxicologist

About the role

The Senior Toxicologist plays a pivotal role in shaping regulatory strategy and scientific direction for tobacco product submissions, including Premarket Tobacco Product Applications (PMTAs). They manage the toxicological risk assessment programs for both conventional and reduced-risk tobacco products, ensuring the data is scientifically robust and supports the product's marketing approval.

Responsibilities

• Lead the development of toxicology strategies for PMTA and other regulatory submissions, ensuring alignment with FDA expectations and public health standards.
• Oversee and conduct human health risk assessments for ingredients, materials, and finished products, with a focus on regulatory compliance and consumer safety.
• Author and manage the toxicology sections of regulatory submissions, ensuring scientific rigor, clarity, and completeness.
• Direct the design, execution, and interpretation of toxicology studies, including in vitro and computational toxicology, often in collaboration with CROs.
• Evaluate and interpret toxicological data, including studies from scientific literature, to determine potential health impacts and support the development of scientific positions.
• Serve as a regulatory-facing subject matter expert, representing the company in FDA meetings, scientific conferences, and industry forums.
• Collaborate cross-functionally with product development, regulatory affairs, and legal teams to integrate toxicology data into broader regulatory strategies.
• Monitor evolving regulatory requirements, toxicological methodologies, and risk assessment frameworks to ensure proactive compliance and innovation.

Qualifications

• Education: Ph.D. or Master’s in Toxicology, Pharmacology, or a related life science field.
• Experience: Minimum of 7–10 years in human health risk assessment, with direct experience in FDA-regulated environments (preferably tobacco, pharmaceutical, or consumer products).
• Certification: Diplomate of the American Board of Toxicology (DABT) strongly preferred; candidates should be willing to obtain if not already certified.
• Expertise: In-depth knowledge of FDA regulatory pathways, especially PMTA and SE submissions. Proven ability to lead toxicological evaluations and regulatory strategy development. Experience with advanced toxicological testing methods, computational modeling, and statistical analysis.
• Strong communication skills, with the ability to present complex scientific concepts to regulatory bodies and non-scientific stakeholders.
• Proficiency in Microsoft Office and scientific data analysis tools.

Benefits

• Competitive benefits package that includes medical, dental, vision, life insurance, and disability plans.
• Dollar-for-dollar 401k match up to 6% and 5% annual company contribution.
• 15 company-paid holidays.
• Generous paid time off.
• Employee recognition and discount programs.
• Education assistance.
• Employee referral bonus program.
• Hybrid workplace – remote / in office.
• Summer hours.
• Casual dress policy Monday through Friday.

Pay

Annual Base Salary Range: $138,417.00 - $184,555.00. Final compensation will be determined based on experience, qualifications, and internal equity. This role may also be eligible for annual bonus or incentive compensation.