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Alcon · 4 days ago

Principal Toxicologist

Durham – Emperor Blvd

Full-time

Onsite

Senior Level, Lead/Staff

5+ years exp

Alcon is a global leader in eye care, dedicated to helping people see brilliantly. The Principal Toxicologist will provide scientific and strategic input for the nonclinical safety assessment of pharmaceutical and medical device products throughout their development.

Health CareManufacturingMedical Device

No H1B

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

Qualification

PhD in ToxicologyNonclinical safety assessmentToxicology principlesRegulatory requirementsBiocompatibility evaluationsData analysisADME conceptsMicrosoft OfficeCommunication skillsOrganizational skillsInterpersonal skills

Required

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

Preferred

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