SUMMARY/JOB PURPOSE
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.
ESSENTIAL DUTIES/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
SUPERVISORY RESPONSIBILITIES
- 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.
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES
Education
- 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.
- DABT or equivalent board certification preferred.
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.
Knowledge, Skills and Abilities
Required:
- 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.
Travel Requirements
- 10% Travel may be required, up to 10% of the time
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Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $285,000 - $405,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
If you have a disability and need an accommodation in relation to the recruiting process, please email us at: ApplicantAccommodations@exelixis.com.
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.