Executive Director, Toxicology
Executive Director, Toxicology
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Salary Not Disclosed
1 Vacancy
Job Description
Position Summary
The Executive Director Toxicology will lead the strategic direction and execution of preclinical toxicology at Acadia playing a critical role in advancing our drug candidates from discovery through late-stage development. This individual will drive the design and oversight of toxicology studies that inform regulatory filings clinical trial design and overall program risk assessment. With deep expertise in translational science and regulatory strategy the Executive Director will partner cross-functionally to ensure timely high-quality toxicology deliverables that support Acadias innovative pipeline.
A collaborative leader and trusted advisor this individual will mentor a high-performing team foster partnerships with CROs and external experts and serve as a key contributor to regulatory submissions and interactions. The ideal candidate brings strong scientific judgment excellent communication skills and a proven ability to integrate toxicology insights into program decision-making.
Primary Responsibilities
- Lead the Toxicology function within Translational Sciences ensuring scientific rigor regulatory compliance and alignment with program deliverables.
- Mentor direct reports to maintain a high-performing and collaborative team.
- Establish and clearly communicate toxicology strategies to program teams with associated reduction-to-practice well-defined.
- Oversee the management of toxicology deliverables supporting both early-stage drug development and later-stage clinical programs.
- Establish productive and collaborative relationships with program collaborators vendors and consultants to complete toxicology packages in support of early-stage assets.
- Collaborate with Translational Science operations and CROs to establish budgets timelines protocol designs and study monitoring as required. Review and finalize study reports.
- Contribute to and drive key document sections for protocols IBs regulatory filings (IND NDA EMEA) and where necessary participate in regulatory interactions.
- Partner with Clinical Pharmacology to maximize efficiency and success of early-stage clinical study design and decision-making.
- Partner with early-stage program leads to maximize efficiencies of early-stage toxicology analyses and identify mechanism-based toxicities / risks early.
- Proactively identify gaps and emerging risks in development programs and engage external experts as needed to inform and guide risk management strategies.
- Provide strategic advice to project teams and senior management including evaluation of conclusions and impact of study results on program and clinical/regulatory strategy
- Remain up to date with innovations in the field and integrate as appropriate those that may inform strategic path or technologic implementation.
- Perform other duties as assigned.
Education/Experience/Skills
PhD in Toxicology or related field. Targeting 15 years of progressively responsible experience conducting toxicology studies within the pharmaceutical or biotech industry including 10 years in leadership role. An equivalent combination of relevant education and experience may be considered.
Key Skills:
- Track record of establishing and mentoring collaborative toxicology teams.
- Proven leadership in toxicology strategy for IND-enabling studies and clinical-stage molecules.
- Successful track record leading the outsourcing and monitoring of toxicology studies effectively interacting with CRO study directors collaborators and consultants as needed in data analyses and interpretation for timely delivery of high-quality toxicology study reports.
- Deep knowledge of FDA EMA and ICH guidance documents and GLP regulations for the conduct of nonclinical safety studies to support regulatory filings
- Experience in authoring nonclinical safety data for submission to regulatory authorities (e.g. IND NDA MAA); experience in preparing science-based responses to health authority queries and presenting to authorities in person or virtually
- Demonstrated leadership in creative problem solving to enable successful drug development with appropriate characterization of risk in complex situations
- Excellent verbal and written communication skills with the ability to clearly present information and decisions to internal and external program teams and senior management.
- Highly collaborative with a desire to work closely with cross-functional colleagues and in a team-based setting
- Must be able to travel domestically and/or internationally on occasions.
Scope
Directs and controls activities through skilled directors and/or managers who have overall responsibility for the direction of assigned areas. With exceptional leadership skills effectively mentors and motivates team members. Works with data and abstract ideas or situations that affect other functional areas of the business and where analysis of situations or data requires collaboration and an understanding of the impact on other functional areas business strategies and the companys overall goals.
Physical Requirements
This role involves regular standing walking sitting and the use of hands for handling or operating equipment. The employee may also need to reach climb balance stoop kneel crouch and maintain visual verbal and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
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Required Experience:
Director
Employment Type
Full Time
