Principal I, Microbiology & Toxicology

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates we innovate fearlessly champion progress and act swiftly to impact global eye health. We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before. Together we make a difference in the lives of our patients and customers. Are you ready to join us

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.

This role is on-site in Fort Worth Texas and would include:

• 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.

What Youll Bring to Alcon:

• Bachelors 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

Preferred Qualifications:

• 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.

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.