Principal I, Microbiology & Toxicology

Alcon Research•Fort Worth, TX

1d•Onsite

About The Position

The Medical Device Toxicologist will serve as a scientific leader and subject matter expert for the biological safety evaluation of medical devices, combination products, materials, and components across the product lifecycle. The role will develop risk-based biocompatibility strategies, integrate chemical and biological evidence, and translate complex toxicology data into clear product-safety conclusions and global regulatory positions. The successful candidate will pair medical device toxicology expertise with toxicology judgment, strategic problem solving, cross-functional leadership, and effective oversight of external laboratories and consultants.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; B.S. +3 yrs; M.S.+2 yrs; PhD +0 yrs).
The ability to fluently read, write, understand and communicate in English.
5 Years of Relevant Experience

Nice To Haves

MS or PhD in Toxicology or a related discipline (e.g., Pharmacology, Biomedical Sciences, Pharmaceutical Sciences, Environmental Health Sciences, etc.).
Relevant experience in pharmaceutical and/or medical device development (industry, postdoctoral, or equivalent).
Direct experience with medical device and/or combination product development across early development, design changes, registration, and postmarket lifecycle management.
Experience preparing regulatory submission content and responding to questions from FDA and other global regulatory authorities.
Knowledge of computational toxicology, including structure-activity relationship approaches, read-across, and weight-of-evidence assessment.
Excellent written and verbal communication skills.
Knowledgeable of pertinent sections of REACH, the EU MDR, and Proposition 65 (hazardous substances regulations) as well as ICH and FDA Guidance Documents (e.g., application of Threshold of Toxicological Concern [TTC] and use of ISO 10993-1 and 10993-17 standards in risk assessments, etc.)
Proficient with statistics and Microsoft suite of office applications.
Demonstrated experience and/or in-depth knowledge developing medical device biological evaluation strategies and applying ISO 10993 standards and related global regulatory expectations.
Experience interpreting chemical characterization and toxicological risk assessment data in support of medical device safety.
Experience overseeing external laboratories, CROs, consultants, or vendors and providing scientific oversight of studies and deliverables.
Demonstrated scientific leadership, strategic problem solving, sound judgment, and the ability to lead cross-functional projects in a matrixed environment.
Excellent written and verbal communication skills, including the ability to influence decisions and present complex scientific conclusions clearly.
Ability to work independently, manage multiple priorities, and rapidly learn new products, systems, and processes.

Responsibilities

Lead development and execution of phase-appropriate, risk-based biological evaluation strategies for new and existing medical devices, combination products, components, materials, manufacturing changes, and product modifications.
Author and critically review Biological Evaluation Plans and Biological Evaluation Reports that integrate device categorization, nature and duration of contact, chemical characterization, toxicological risk assessment, existing data, and biological testing.
Apply ISO 10993 principles, including ISO 10993-1, to determine relevant biological endpoints and establish scientifically justified testing, read-across, bridging, or testing-waiver strategies.
Integrate device extractables and leachables data, chemical and material characterizations, and exposure information with toxicological hazard data to assess patient risk and support product safety conclusions.
Develop toxicological risk assessments for identified constituents and establish health-based exposure limits using relevant toxicology principles, weight-of-evidence methods, and computational toxicology tools.
Serve as the medical device toxicology and biocompatibility subject matter expert on product development, lifecycle management, remediation, and regulatory-response teams.
Critically evaluate complex or conflicting data, identify evidence gaps and product-safety risks, and recommend pragmatic, science-based paths forward that balance patient safety, regulatory expectations, program timing, and business needs.
Lead biocompatibility workstreams and integrated project plans, including scope, milestones, dependencies, timelines, budgets, risks, and decision points.
Contribute to global regulatory submissions and responses by authoring, reviewing, and defending medical device toxicology and biocompatibility content.