Senior Scientific Director, Toxicology Job at ChemSource, San Diego, CA

RmJXZURncUtKbVlUejI3eXo0dTdmWHBoRFE9PQ==
  • ChemSource
  • San Diego, CA

Job Description

Senior Scientific Director, Toxicology

About the Role:

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. Represent 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
  • Evaluate, interpret and summarize 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.)
  • Represent 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
  • Maintain 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 (CRO's)
  • Demonstrated experience in the of preparation of INDs, CTAs, NDAs, and MAAs
  • Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of multiple scientific areas

Job Tags

Contract work,

Similar Jobs

Thind Management

Hotel Assistant General Manager Job at Thind Management

 ...Hotel Assistant General Manager Introduction Welcome to Thind Management , a family-owned management company where we strive to provide exceptional service and unforgettable experiences to our guests at our properties . With a passion for hospitality and... 

Mayo Clinic

Patient Care Assistant - Rochester Full Time - $2500 New Hire Incentive Job at Mayo Clinic

 ...Care Assistant willbe hired to work at either the Saint Marys Hospital or Rochester Methodist Hospital Campus. The Patient Care Assistant...  ...against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities... 

Martin Baker America

Associate Buyer Job at Martin Baker America

 .... 6. Builds relationships with suppliers by working through issues, development, strategies, etc. Experience: Desired Entry Level position. Minimum one (1) year experience in purchasing or related fields, i.e., manufacturing, aerospace, defense, business, finance... 

BayMark - BAART Programs Salt Lake City

Travel Licensed Practical Nurse Long-Term Care Job Job at BayMark - BAART Programs Salt Lake City

Embark on an exciting journey as a Licensed Practical Nurse in Long-Term Care, based in the beautiful state of Utah, Murray. This is an incredible...  ...work environment. You'll have access to 24/7 support while traveling with our company, ensuring that you always have someone to... 

A2e Technologies

Sr. Embedded Software/Firmware Engineer/Contractor Job at A2e Technologies

 ...Title: Sr. Embedded Software/Firmware Engineer/Contractor Location: San Diego (92121) Term: Long Term Contract Duration: Long Term Start: Immediately Seeking Client facing Sr. Embedded Software/Firmware Engineer for a Hybrid role. Contractor with...