Senior Scientific Director, Toxicology
Company: ITech Consulting Partners
Location: San Diego
Posted on: November 6, 2024
Job Description:
As a Sr. Leader, executes the strategic direction of the
Toxicology function. Ensures that toxicology studies and programs
are conducted in accordance with the appropriate guidelines and
regulatory test standards (FDA, WHO, GLP, and ISO). Oversees and
evaluates protocol preparation for toxicology studies and reviews
reports. Advises and directs the analysis, interpretation and
reporting of Safety Pharmacology and Toxicology data for discovery
and development programs. Designs and develops overall Safety
Pharmacology and Toxicology development strategies for toxicology
programs. Recommends longer term strategies to ensure effective
achievement of strategic and operational objectives. Represents
Preclinical development on discovery and development teams and
regularly interfaces with internal and external colleagues to
ensure timely and accurate dissemination of Safety Pharmacology and
Toxicology findings. Supports Sr. Leadership with in-life resource
planning, maintaining current testing procedures, program
development, performance monitoring, budget planning and resource
management.Your Contributions (include, but are not limited
to):
- Develops, implements and directs toxicology strategies to
support assigned discovery and development programs.
- 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 toxicology results and
proactively provides strategic direction to project teams and
senior management on the potential impact of toxicology results on
Program and Clinical/Regulatory strategy.
- Advises and directs the preparation of Safety Pharmacology and
Toxicology sections of regulatory documents (IND, CTA, NDA,
briefing books, Investigator Brochures, etc.).
- Represents Preclinical Development on discovery and
development-stage program teams.
- Provides strategic oversight and direction for the preparation
of data summaries and contributes to the presentation of results to
peers, colleagues and Company Management.
- Oversees and drives the preparation of SOPs as needed to guide
functional activities and ensures adherence to SOPs.
- Oversees the adherence of regulatory toxicologists to all
Toxicology SOPs.
- Maintains current knowledge of regulatory guidance, industry
standards and recommendations.
- Participates in the selecting, developing and evaluating
personnel to ensure the efficient operation within the toxicology
group.
- Other tasks as assigned.Requirements:
- PhD in Toxicology, Pathology or closely related discipline and
10+ years of pharmaceutical/biotech experience, including managing
clinical Contract Research Organizations.
- Exhibits ability to become company-wide advisor and emerging
industry expert.
- Demonstrated strategy development and implementation within
areas of responsibility.
- Possesses expert knowledge of own function and broad knowledge
of multiple functions and impact on business.
- Proven leadership skills and ability, including influencing
across many levels of the organization.
- Expert knowledge of drug development strategies for various
modalities including small molecules, biologics, therapeutic
peptides, therapeutic areas (including neuroscience and
endocrinology) and regulatory regions including US, Canada, Europe
and Japan.
- Expert knowledge of managing clinical Contract Research
Organizations (CROs).
- Demonstrated experience in the preparation of INDs, CTAs, NDAs,
and MAAs.
- Maintains broad knowledge of scientific principles and theories
and possesses intellectual mastery of multiple scientific
areas.
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Keywords: ITech Consulting Partners, Moreno Valley , Senior Scientific Director, Toxicology, Executive , San Diego, California
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