Executive Director, Toxicology

Exelixis•Alameda, CA

4d•Onsite

About The Position

The Executive Director, Toxicology leads a team of toxicologists who develop and implement nonclinical safety strategies for small and large molecule programs in an inter-departmental, project team-based structure. Establish and maintain the vision, strategy, scientific standards and operating model for the Toxicology function to support organizational objectives and portfolio growth.

Requirements

PhD in Toxicology, Pharmacology, Pathology, DVM or related discipline and a minimum of 15 years of relevant experience; or, Equivalent combination of education and experience.
Extensive experience leading toxicology, nonclinical safety and safety pharmacology activities in a regulated biotechnology or pharmaceutical environment.
Experience supporting discovery, IND-enabling, clinical development, and global regulatory submission activities.
Experience managing CROs, external partners, cross-functional project teams and people leaders.
Comprehensive knowledge of nonclinical safety assessment, toxicology, safety pharmacology, DMPK, GLP regulations, global regulatory expectations and drug development from discovery through registration.
Advanced leadership, communication, collaboration, analytical, problem-solving, decision-making and influencing skills.
Ability to operate effectively in complex matrix environments, manage ambiguity, assess risk, and communicate scientific recommendations to senior leaders, regulatory agencies, development partners and cross-functional teams.

Nice To Haves

DABT or equivalent board certification preferred.

Responsibilities

Lead Toxicology strategy for small molecule and biotherapeutic programs from discovery through registration.
Define integrated nonclinical safety, safety pharmacology, toxicokinetic, pharmacokinetic, and drug metabolism strategies that support candidate selection, IND-enabling activities, clinical development, and global regulatory submissions.
Oversee the design, conduct, monitoring, interpretation and reporting of GLP and non-GLP toxicology, safety pharmacology and investigative toxicology studies conducted internally or through CROs.
Represent Toxicology on project teams, governance forums, regulatory meetings and development partner interactions; communicate scientific rationale, risk assessments and recommendations to senior leadership.
Author, review and defend nonclinical pharmacology, toxicology and safety sections of regulatory documents, including pre-IND packages, INDs, CTAs, IBs, NDAs, BLAs and global marketing applications.
Partner with Discovery, Clinical Pharmacology, Translational Sciences, Pathology, Regulatory Affairs, Clinical Development, CMC, Quality Assurance, CROs, and external collaborators to drive integrated development plans and risk-based decision-making.
Manage CRO and external partner relationships to ensure study quality, compliance, timelines, budgets, data integrity and timely delivery of nonclinical outputs.
Identify and resolve nonclinical safety issues that may affect program progression; develop de-risking strategies and recommendations based on scientific, regulatory and portfolio considerations.
Develop resource plans, budget forecasts, organizational capabilities and scalable processes to support current and future portfolio needs.
Drive external scientific visibility through appropriate publications, presentations, partnerships and participation in relevant scientific forums.
Build organizational capability through succession planning, leadership development, talent assessment and creation of a high-performing scientific culture.
Performs other duties as assigned
Complies with all policies and standards
Attracts, hires, retains and develops high-performing scientists and scientific leaders; fosters an innovative, science-driven work environment; establishes measurable objectives and provides ongoing coaching, feedback and performance management.
Leads, trains and mentors staff to develop and expand their expertise and encourages them to create innovative solutions that will increase scientific knowledge and technical capabilities.
Identifies resources and capabilities required to support current and future portfolio needs; deploys staff according to portfolio priorities, resource availability and business objectives; manages group goals, timelines and budgets.