Job Description

About the Job:

Senior Scientific Director, Toxicology

As the Senior Scientific Director of Toxicology, you will play a pivotal role in shaping the strategic direction of our Toxicology function within a leading pharmaceutical company. This high-impact position focuses on ensuring that toxicology studies and programs are conducted in compliance with international guidelines such as FDA, WHO, GLP, and ISO. You will oversee the preparation and review of protocols, manage the analysis, interpretation, and reporting of Safety Pharmacology and Toxicology data, and drive the development of toxicology strategies for diverse developmental programs. Through your expert knowledge and leadership, you will influence project teams and senior management, guiding the integration of toxicology findings into broader program and clinical/regulatory strategies.

Compensation: DOE

Essential Duties and Responsibilities:

• Develop and implement toxicology strategies to support discovery and development programs.
• Plan and oversee execution of Safety Pharmacology and Toxicology studies and data analysis across all programs.
• Ensure timely completion of activities within the regulatory Toxicology function by directing assignments and priorities.
• Evaluate, interpret, summarize toxicology results, and advise project teams and senior management on strategic implications.
• Prepare and direct Safety Pharmacology and Toxicology sections of regulatory submissions including INDs, CTAs, NDAs, and briefing books.
• Represent Preclinical Development in discovery and development-stage program teams, influencing cross-functional decision-making.
• Provide strategic oversight for the preparation of data summaries and presentations to peers, colleagues, and company management.
• Drive the preparation and adherence to SOPs within the Toxicology function.
• Maintain and update knowledge on regulatory guidance, industry standards, and recommendations.
• Participate in the recruitment, development, and evaluation of personnel within the toxicology group and supervise their adherence to Toxicology SOPs.

Minimum Position Qualifications:

• PhD in Toxicology, Pathology, or a closely related discipline.
• Minimum of 10 years experience in the pharmaceutical/biotech industry.
• Demonstrated strategy development and implementation skills within allocated responsibilities.
• Extensive knowledge of drug development processes for various modalities including small molecules and biologics.
• Proven track record in managing clinical Contract Research Organizations (CROs).
• Experience in the preparation of INDs, CTAs, NDAs, and MAAs.

Preferred Qualifications:

• More than 15 years of relevant industry experience.
• Demonstrated ability to act as a company-wide advisor and recognized industry expert.
• Experience in leadership roles with significant influence across multiple organizational levels.
• Advanced understanding and application of regulatory requirements in the US, Canada, Europe, and Japan.
• Intellectual mastery of multiple scientific areas within toxicology and safety pharmacology.

Skills:

• Excellent leadership and team management skills.
• Strong strategic thinking and analytical skills.
• Superior communication and presentation skills, adept at data summary and report writing.
• Profound knowledge in GLP and regulatory standards.
• Ability to foster a collaborative work environment.

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