Senior Toxicologist – Project-Based Contractor

Senior Toxicologist – Job Description
Job Title: Senior Toxicologist – Project-Based Contractor
Department: Operations
Reports To: Vice President, Operations
Location: Remote
Employment Type: Part-Time (Ad Hoc)
Position Summary
The Senior Toxicologist is an ad hoc, project-based independently contracted role serving as Groenakker's senior technical authority for the toxicological risk assessment of medical devices. Work is assigned per project rather than on a fixed weekly schedule. As part of Groenakker's global Operations team, this role converts chemical characterization data into defensible patient risk conclusions and supports those conclusions through regulatory review. The scope of this role is medical device toxicology specifically — constituent review and risk assessment under the ISO 10993 series — rather than general pharmaceutical, chemical, cosmetic, food, or environmental toxicology.
Key Responsibilities
Author and review Toxicological Risk Assessments (TRA) for medical devices in accordance with ISO 10993-17 and ISO 10993-1, based on chemical characterization data generated under ISO 10993-18.
Evaluate extractables and leachables data sets, confirm constituent identity, and resolve unknown and tentatively identified compounds to an appropriate level of confidence.
Derive tolerable intake and tolerable exposure values, apply the threshold of toxicological concern where justified, calculate margins of safety, and document the uncertainty factors and read-across rationale supporting each conclusion.
Establish exposure assumptions consistent with the device's clinical use, nature and duration of body contact, and patient population, including pediatric and other sensitive populations where applicable.
Perform constituent-level literature and database review and document the search strategy to a standard that withstands regulatory scrutiny.
Support biological evaluation strategy by determining which endpoints can be addressed through chemical characterization and risk assessment in place of animal testing.
Author toxicology content for regulatory submissions and defend conclusions in FDA Pre-Submissions, 510(k) reviews, Additional Information requests, and European MDR technical documentation.
Assess the impact of changes to standards, guidance, and FDA recognition status — for example the partial recognition of ISO 10993-1:2025 under Recognition No. 2-313 — on active client programs and advise on required action.
Train and mentor junior scientists and reviewers on risk assessment methodology and documentation standards.
Perform other project-related duties as agreed within the applicable Statement of Work.
Required Qualifications
Ph.D. or Master’s degree in Toxicology, Pharmacology, Biochemistry, Environmental Health, or related scientific field.
8+ years of relevant toxicology experience in industry, consulting, academia, or regulatory environments.
Strong knowledge of toxicological principles, risk assessment methodologies, and regulatory frameworks.
Experience with regulatory submissions and compliance documentation.
Excellent analytical, scientific writing, and communication skills.
Ability to manage multiple projects and work collaboratively across departments.
Proficiency in scientific literature review and data interpretation.
Preferred Qualifications
+8 Years relevant toxicology experience, including demonstrated medical device toxicological risk assessment experience under ISO 10993-17.
A bachelor's degree or higher in toxicology, pharmacology, chemistry, or a closely related scientific field.
Board certification or registration in toxicology (DABT, ERT, or equivalent).
Demonstrated ability to interpret chemical characterization data generated under ISO 10993-18 and translate it into a defensible device risk position.
Preferred Knowledge Skills And Abilities
An advanced degree (master's or doctorate) in toxicology, pharmacology, or a closely related scientific field.
Experience defending toxicological conclusions directly with FDA reviewers in a Pre-Submission or Additional Information exchange.
Familiarity with ISO 18562, USP and , and permitted daily exposure derivation under ICH Q3D or a comparable framework.
Experience applying computational toxicology, QSAR, and in silico read-across tools as supporting evidence.
Excellent communication skills and customer-oriented empathy.
Ability to effectively work remotely with limited supervision while managing concurrent client projects.

Work arrangement
Yes