16 days old

Vice President, Safety Assessment-gRED Development Sciences

Roche
South San Francisco, CA

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 â 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

Requirements:

  • 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

Posted: 2018-11-06 Expires: 2018-12-20

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Vice President, Safety Assessment-gRED Development Sciences

Roche
South San Francisco, CA

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