South San Francisco
California, United States of America
Core Role and Responsibility
Manage and lead the Safety Assessment (SA) organization in gRED
SA comprises 3 major departments (Toxicology, Pathology, Operations) with a total FTE= 96; ~102 including full time contractors
SA is responsible for ensuring patient safety of gRED drug candidates through exhaustive non-clinical evaluations
SA supports the entire gRED pipeline from Research to Registration for all therapeutic areas and for both Large Molecule and Small Molecule programs
SA is responsible for ensuring Genentech compliance with worldwide regulations governing the conduct of nonclinical studies in support of global clinical trials and new drug approvals
SA supports global worker safety and product quality by performing evaluations in compliance with worldwide regulations governing the proper manufacture of drugs
SA conducts both regulated and exploratory nonclinical studies in close partnership with Research and Early Clinical Development, to enable selection of optimized clinical candidates thus ensuring delivery of the pipeline
Core Duties as Head of Safety Assessment
Responsible for ensuring compliance with worldwide regulations governing the conduct of nonclinical studies in support of global clinical trials and registration and marketing authorization of new drug candidates
Responsible for ensuring proper resources are provided to the SA organization and that proper management and mentorship is provided to staff, to ensure business critical deliverables are met, and that the work performed is of the highest quality and compliance
Responsible for ensuring that budgets are properly managed, and that proper work processes are in place to manage the work, from an internal business audit perspective
Responsible for establishing vision and strategic direction to SA, to ensure the organization continues to deliver the pipeline, and to ensure incorporation of cutting edge scientific technologies and drug development strategies
Chair of the departmental functional review committee
Ensure succession, recruitment and career development strategies are in place to develop, hire and retain the best and the brightest staff and future leaders
Global Roche Roles and Responsibilities as Head of Safety Assessment
Final functional reviewer for all global Health Authority submissions and communications
Co-chair of the Expedited Safety Reporting committee, whose role is to determine whether nonclinical adverse events should be communicated in expedited fashion to global Health Authorities
gRED voting member (or delegate) of the global Roche Drug Safety Committee – whose remit is to ensure compliance with worldwide regulations governing patient safety and whose recommendations are reviewed/endorsed by the CMO of Roche
Oversight of the Product Quality and Occupational Toxicology (PQOT) department in SA, whose staff partner and work across the global Roche organization, and whose function includes establishing worker exposure limits and performing risk assessments for drug impurities/contaminants for the global manufacturing organization
Ad hoc advisor to the Late Stage Product Development leadership and drug development teams: provide strategic input on safety issues in order to move late stage programs forward and to help enable informed portfolio decisions
Education: PhD and/or DVM. Postdoctoral experience preferred.
Certifications: DABT and/or DACVP and/or ERT preferred but not crucial
15+ years of relevant industry experience working in a pharmaceutical company
Working knowledge of global regulatory guidelines associated with quality and compliance in the conduct of nonclinical safety studies
Scientific and Management Leadership experience: strategic oversight and organizational management of toxicology and/or pathology departments responsible for delivering drug candidates
Experience in both Research and Development preferred
Ability to effectively partner across a globally diverse network of stakeholders and collaborators to ensure delivery of the pipeline
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.
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