Principal Scientist- Toxicologist (Translational Safety)

Genentech • Daly City, CA

3d • Onsite

About The Position

The Department of Translational Safety at Genentech is seeking a highly motivated toxicologist for a Principal Scientist role to lead nonclinical studies and safety strategies in the process of drug development from discovery through marketed products. This position requires a solid track record of scientific productivity and strong leadership in strategic planning and execution in the areas of toxicology and safety assessment.
The Opportunity:
This project team-facing role involves close collaboration with departmental colleagues and cross- functional teams across developmental stages, molecular modalities and therapeutic areas. The team member will manage projects and demonstrate appropriate decision-making capabilities that take into account cross-functional aspects, understand the impact of such decisions and design, conduct and integrate findings of toxicology programs in support of drug candidate development at Genentech.
As an integral member of this dynamic team, you will be:
Creating a best-evidence based synthesis of existing knowledge and comprehensive
investigations of toxicologic activity.
Designing and supervising in vitro and in vivo toxicology studies, work closely with study monitors, pathologists and pharmacokinetic scientists, biomarker scientists, clinical scientists, etc., to deliver high quality GLP and non-GLP study reports and represent Genentech in meetings with regulatory authorities, as needed.
Participating in interdisciplinary project teams, prepare and review regulatory documentation, study reports and manuscripts, participate in toxicology and pharmacology
initiatives, as well as other active cross-functional collaborations.
Leading hypothesis-driven investigation into mechanisms of toxicity, proactively manage potential safety liabilities and communicate impact to teams and governance committees.
Socializing complex science-based messages and processes at all levels within the department and across the organization.
Executing above responsibilities through informed interpretation and compliance with evolving global and company regulations and guidances, including outreach, education and alignment of practices with internal stakeholders.
Coaching and developing internal staff or peers, as appropriate.

Requirements

• PhD plus post-doc or equivalent experience in toxicology or related discipline.
• 3-7 years of relevant, professional relevant experience as toxicology project lead in the biopharmaceutical industry.
• Solid track record of scientific productivity (i.e. publications, conference presentations, etc.), and strong scientific leadership in strategic planning and execution in the areas of toxicology.
• Demonstrate strong decision-making, complex problem solving, project management, critical data analysis and interpretation skills.
• Qualifications or special skills that include strategic program development and leadership, collaboration, influencing/negotiating skills, etc. are a must.
• Excellent verbal and written communication skills, including strong technical writing and presentations.

Nice To Haves

• Strong experience in immunology and/or immunotoxicology and board certification in toxicology are highly desirable.

Responsibilities

• Creating a best-evidence based synthesis of existing knowledge and comprehensive investigations of toxicologic activity.
• Designing and supervising in vitro and in vivo toxicology studies, work closely with study monitors, pathologists and pharmacokinetic scientists, biomarker scientists, clinical scientists, etc., to deliver high quality GLP and non-GLP study reports and represent Genentech in meetings with regulatory authorities, as needed.
• Participating in interdisciplinary project teams, prepare and review regulatory documentation, study reports and manuscripts, participate in toxicology and pharmacology initiatives, as well as other active cross-functional collaborations.
• Leading hypothesis-driven investigation into mechanisms of toxicity, proactively manage potential safety liabilities and communicate impact to teams and governance committees.
• Socializing complex science-based messages and processes at all levels within the department and across the organization.
• Executing above responsibilities through informed interpretation and compliance with evolving global and company regulations and guidances, including outreach, education and alignment of practices with internal stakeholders.
• Coaching and developing internal staff or peers, as appropriate.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees