Principal Toxicologist

Alcon Research•Durham, NC

5d•Onsite

About The Position

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. The Principal Toxicologist will provide scientific and strategic input to support the nonclinical safety assessment of pharmaceutical and medical device products across all stages of development. This role is on-site in Durhan, North Carolina and a typical day would include: Lead development and execution of phase-appropriate nonclinical safety assessment program strategies with integrated project plans including milestones, timelines, and budgets. Review, summarize and integrate complex datasets across all nonclinical safety disciplines (toxicology, safety pharmacology, genotoxicity, developmental & reproductive toxicology, immunotoxicology, etc) for project teams, portfolio management, senior leaders, internal/external partners and/or scientific groups. Critically evaluate and interpret results of nonclinical safety assessment studies and contribute to authoring of global regulatory documents (INDs, NDAs, IBs, etc). Support phase-appropriate control strategies for impurities, excipients, residual solvents, and raw materials including application of computational toxicology, preparation of risk assessment/toxicology monographs, determination of risk-based limits (e.g., PDEs, ADIs). Collaborate with internal stakeholders and external partners (CROs, consultants) to ensure timely and high-quality execution of nonclinical deliverables. Work closely with cross-functional teams to provide conduct and lead toxicological risk assessments for new and existing medical devices, components, and materials. This includes creating Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in accordance with ISO 10993 and responding to questions from regulatory agencies. Identify and assess business/technical project risks and recommend/influence contingency plans for risk mitigation. Apply technical expertise to solve complex biocompatibility problems as related to the ISO 10993 standards and regulatory authority requirements for product safety.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 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

PhD in Toxicology or a related discipline (e.g., Pharmacology, Biomedical Sciences).
Relevant experience in pharmaceutical and/or medical device development (industry, postdoctoral, or equivalent).
Strong understanding of toxicology principles and regulatory requirements for nonclinical safety assessment.
Excellent written and verbal communication skills.
Knowledge of, and experience with, nonclinical small molecule development, drug metabolism, ADME concepts, pharmacokinetics, safety/toxicology, pharmacodynamic and bioanalytical principles
Practical knowledge of the laboratory methods and analytical techniques associated with medical device and/or combination product biocompatibility and chemical characterization evaluations
Demonstrated strong decision making and complex data analysis and interpretation relating to drug development
Strong communication, organizational and interpersonal skills to work within a matrix setting
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., Threshold of Toxicological Concern and Use of ISO 10993-1, etc.)
Proficient with statistics and Microsoft suite of office applications.

Responsibilities

Lead development and execution of phase-appropriate nonclinical safety assessment program strategies with integrated project plans including milestones, timelines, and budgets.
Review, summarize and integrate complex datasets across all nonclinical safety disciplines (toxicology, safety pharmacology, genotoxicity, developmental & reproductive toxicology, immunotoxicology, etc) for project teams, portfolio management, senior leaders, internal/external partners and/or scientific groups.
Critically evaluate and interpret results of nonclinical safety assessment studies and contribute to authoring of global regulatory documents (INDs, NDAs, IBs, etc).
Support phase-appropriate control strategies for impurities, excipients, residual solvents, and raw materials including application of computational toxicology, preparation of risk assessment/toxicology monographs, determination of risk-based limits (e.g., PDEs, ADIs).
Collaborate with internal stakeholders and external partners (CROs, consultants) to ensure timely and high-quality execution of nonclinical deliverables.
Work closely with cross-functional teams to provide conduct and lead toxicological risk assessments for new and existing medical devices, components, and materials. This includes creating Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in accordance with ISO 10993 and responding to questions from regulatory agencies.
Identify and assess business/technical project risks and recommend/influence contingency plans for risk mitigation.
Apply technical expertise to solve complex biocompatibility problems as related to the ISO 10993 standards and regulatory authority requirements for product safety.