Senior Scientist, Development Toxicology
Join a Team that Lives to Improve Lives
People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen.
The following opportunity exists in our South San Francisco, CA headquarters:
Senior Scientist, Development Toxicology
The Department of Safety Assessment is responsible for the nonclinical safety assessment of all drug candidates in the portfolio of Genentech from the discovery phase up to support of marketed products. Safety Assessment provides scientific leadership and plays an active cross-functional role in the drug development process. Within Safety Assessment, Development Toxicology provides toxicology support to the Development small molecule and biotherapeutics portfolio from clinical candidate selection up to post-marketing support. We are seeking a Senior Scientist/ Toxicologist and Subject Matter Expert Genotoxic Impurities in Development Toxicology to lead the assessment and categorization of the mutagenic potential of impurities during clinical development and subsequent applications for marketing. The individual may also apply this skill set to prediction of genotoxicity and chemical reactivity of APIs (active pharmaceutical ingredients). This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing toxicology representation and expert guidance to technical and development teams.
The successful candidate for the role is a recognized expert in the in silico genotoxic assessment of impurities and/or APIs who will provide scientific leadership for Safety Assessment in identification, categorization, qualification and control of impurities in new drug substances/ products to limit a potential carcinogenic risk in compliance with international guidance and global regulatory expectations. The individual may also partner with Discovery Toxicology to develop a strategy for in silico genotoxicity assessment of APIs. The Senior Scientist/ Toxicologist will develop and apply quantitative structure-activity relationship ((Q)SAR) models and expert knowledge to support internal decision-making, phase-appropriate control strategies, and global regulatory filings and interactions with a strong emphasis on Genentech’s small molecule development project portfolios.
Working in a collaborative team environment, the Senior Scientist/ Toxicologist provides expert advice/ guidance to peers and senior leaders in Safety Assessment and to project and technical teams, and represents Safety Assessment at related internal review boards in support of program advancement. In addition, the successful candidate represents Genentech in the external scientific community and plays an active role in cross-industry initiatives or at scientific conferences/ professional societies.
Responsibilities include interdisciplinary project team support, scientific leadership in the design and implementation of comprehensive reactive impurity assessment strategies to support program advancement and decision-making, preparation and review of regulatory documentation, representation of Genentech in meetings with regulatory authorities, proactive management of potential safety liabilities and communication of impact to teams and governance committees. Experience with cross-functional teams and capability to build productive cross-functional internal and external collaborations are desired.
Additional responsibilities, as needed, include mentoring of toxicologists and team members, leadership of cross-functional nonclinical sub-teams or initiatives, and leadership or support of inter- and intra-departmental initiatives.
Who You Are
- A PhD and post-doctorate or equivalent experience in toxicology or chemistry along with significant scientific achievements or drug development experience and a minimum of 5-7 years of relevant experience in the pharmaceutical industry or regulatory environment.
- A strong scientific background in chemical and/ or computational toxicology and in the use of state-of-the-art computational models, in silico based drug safety predictions, and chemical expert knowledge/ interpretation for the safety assessment of pharmaceutical drug development candidates and/or impurities.
- Extensive experience in the technical aspects of (Q)SAR and application in regulatory context of the International Conference on Harmonisation (ICH) M7 guidance.
- Evidence of consistent and extensive record of scientific and/or regulatory impact internally and externally.
- Board certification in toxicology is highly desirable.
The successful candidate must also demonstrate strong decision-making, complex problem solving, critical data analysis and interpretation, excellent written and verbal communication skills; and the ability to build productive cross-functional collaborations both within and external to Genentech
A Job with Benefits Beyond the Benefits
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button below.
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