Senior Scientific Director, Toxicology Job at Precisionmachining.jobs, San Diego, CA

RmJHWkNnYUdKR3dRdzJUL3pJeThlbkpnRHc9PQ==
  • Precisionmachining.jobs
  • 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

Lighthouse

Director of Real Estate Development & Construction Management Job at Lighthouse

Description: describes the general nature and level of work performed by employees assigned to this position. It should not be construed as an exhaustive list of all required duties, responsibilities, and skills. Lighthouse is an equal opportunity employer, and does not...

Loram

Supplier Quality Engineer Job at Loram

 ...Job Title: Engineer, Supplier Quality FLSA Status: Exempt Department: Quality Assurance Reports to: Manager, Operational Quality Flex Work Eligible! This position qualifies...  ...30 work days annually to work from home! The initial amount of days is prorated... 

Medfamily Wellcare Center

Licensed Clinical Social Worker-Medical Social Worker Job at Medfamily Wellcare Center

The LCSW-Social Worker for Case Management provides psychosocial support to patients with complex needs by collaborating with healthcare teams and community agencies. They conduct assessments, offer crisis intervention, facilitate referrals, and develop safe discharge... 

Planet Fitness

Fitness Trainer Job at Planet Fitness

 ...Application", you will be directed to this 2nd step"* The Fitness Instructor / Fitness Trainer will be responsible for running...  ...veterano protegido o cualquier otra caracterstica protegida por la ley. JOIN THE CLUB. Enhancing peoples lives with an affordable... 

Johnson Controls

HVAC O&M Mechanic Apprentice (union) Job at Johnson Controls

 ...Are you looking to gain Heating, Ventilation, & Air Condition (HVAC) knowledge and learn firsthand from industry leading professionals...  ...needed. You will meet attendance requirements for required Union training for first year. Provide recommendations and solutions...