Sr. Scientific Director, Toxicology

About the role

Develops, implements and directs the scientifically sound and regulatory authority-acceptable toxicology strategies that support safety assessments for a R&D portfolio spanning early drug discovery through clinical development and market authorization.

Supports planning and execution of Safety Pharmacology and Toxicology studies/data for all programs.

Oversees and directs assignments within the regulatory Toxicology function to ensure timely completion of priority activities.

Evaluates, interprets and summarizes safety pharmacology and toxicology results and proactively provides strategic direction to project teams and senior management on the potential impact of results on Program and Clinical/Regulatory strategy.

Advises and directs the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures, etc.).

Represents Toxicology and work closely with R&D functions to integrate toxicology strategies into the research/development plan, provide scientific insight into the safety profile, and de-risk potential safety liabilities.

Supports Sr. Leadership with in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning and resource management.

Responsibilities

• Develops, implements and directs the scientifically sound and regulatory authority-acceptable toxicology strategies that support safety assessments for a R&D portfolio spanning early drug discovery through clinical development and market authorization.
• Supports planning and execution of Safety Pharmacology and Toxicology studies/data for all programs.
• Oversees and directs assignments within the regulatory Toxicology function to ensure timely completion of priority activities.
• Evaluates, interprets and summarizes safety pharmacology and toxicology results and proactively provides strategic direction to project teams and senior management on the potential impact of results on Program and Clinical/Regulatory strategy.
• Advises and directs the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures, etc.).
• Represents Toxicology and work closely with R&D functions to integrate toxicology strategies into the research/development plan, provide scientific insight into the safety profile, and de-risk potential safety liabilities.
• Supports Sr. Leadership with in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning and resource management.

Requirements

• PhD in Toxicology, Pathology or closely related discipline and 10+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations.
• D.V.M. and 8+ years of similar experience noted above.
• Expert knowledge in development of various modalities, especially Biotherapeutics (bispecific or trispecific antibodies, BBB shuttles, peptide conjugates), oligonucleotides, and gene therapies desired.
• Demonstrated experience in the preparation of INDs, CTAs, BLAs/NDAs/MAAs, briefing books, Investigator’s Brochures.
• Expert in regulatory strategies for various modalities in US, Canada, and Europe.
• Demonstrate strategy development and implementation within areas of responsibility.
• Extensive experience in managing clinical Contract Research Organizations (CRO's).
• Possesses expert knowledge of own function and broad knowledge of multiple functions and impact on business.
• Possesses proven leadership skills and ability, including influencing across many levels of the organization.
• Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of multiple scientific areas.

Skills

Expert knowledge of global Good Laboratory Practices and Health Authority requirements for nonclinical safety data that support clinical trials and market authorization of investigational medicinal products.

Benefits

The annual base salary we reasonably expect to pay is $226,600.00-$309,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program.

Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.