TOXICOLOGIST LATE STAGE ASSET LEAD – SWITZERLAND

Toxicologist Late Stage Asset Lead – Switzerland

Location: -, Genève

Category: Professional Services

Salary: Apply for details

Country: Switzerland

Employment: Direct Hire/Perm

Worksite: On-Site

Summary

You will be collaborating cross-functionally to drive program success and regulatory alignment, in a dynamic environment with bold corporate objectives. This is a critical role within our PharmTox team, requiring a strong scientific background and excellent communication skills to collaborate across various capabilities.

Role Responsibilities

• Provide expert scientific advice on risk assessment of potential impurities of products
• Be the single point of contact for impurity and E&L risk assessments in drug substances and drug products across the portfolio
• Be a single point of contact and support EHS by managing toxicological risk assessments linked to safety datasheets
• Outsource, guide and approve toxicological evaluations of E&L profiles associated with container closure systems, devices, and manufacturing components
• Oversee the appropriate application of risk assessment methodologies (e.g. PDE, TTC, OEL) in accordance with ICH and EMA/FDA guidelines
• Together with our expert partners, interpret in silico (Q)SAR analyses and, where appropriate, propose and evaluate in vitro/in vivo studies
• Collaborate with cross-functional teams to elaborate compliant and scientifically sound control strategies
• Develop best practices, identify resources, gaps and opportunities for improvement. Ensure that risk assessments remain contemporaneous of industry trends and regulatory requirements
• Support Regulatory processes for mature product (geographic expansions and license maintenance)
• Be the main partner for colleagues in the regulatory groups and support with expert advice on toxicology aspects of assigned projects
• Responsible for non-clinical aspects of periodic safety reporting of assigned projects
• Together with expert partners and CMC, support biological safety risk assessments of medical devices
• Lead network of external partners, together with Global Sourcing, maintain and expand productive relationships.

Desired Skills And Experience

• Ph.D degree or equivalent by experience
• Degree in toxicology or equivalent, professional board certification preferred
• At least 5 years of industry experience in a relevant position
• Board certification (ERT, DABT) is a plus
• Effective in organizing self and others, highly structured
• Strong literature mining and excellent authoring skills of technical and regulatory documents
• Clear communication, can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.