Executive Director, Toxicology

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