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

aC9HaC9UZXZTdUhJY2dYRXdKckRaYStyQ3c9PQ==
  • 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

Headway

Licensed Mental Health Counselor Job at Headway

 ...clients you see through Headway, so that you can set the hours that work for you. Grow your caseload by providing marketing support and...  ...patients in-person or remotely via telehealth while working from home. We accept the following licenses on a state by state basis:... 

Bear Down Associates LLC

Graphic Designer Job at Bear Down Associates LLC

 ...essentials that enhance the way you care for yourself and the world around you. We are looking for a growth-oriented Graphic Designer for our 4 brands - Pure Enrichment, Bentgo, Brusheez, and Verilux. The ideal candidate is strategic, creative, and passionate about... 

Bestlogic Staffing

Graphic Design Intern Job at Bestlogic Staffing

 ...We are seeking creative innovative graphic design intern to join our team (Spring Semester...  ...clients and the staffing agency. This internship will help you acquire and develop...  ...strategies. Ultimately, you will gain broad experience in marketing and advertising and... 

Karen Clark & Company

Senior Actuary Job at Karen Clark & Company

KCC seeks a fulltime Actuary in our Boston office to partner with clients to leverage catastrophe model output in underwriting, ratemaking, and risk transfer initiatives. Your responsibilities will also include fostering relationships with insurance regulators and rating... 

TotalMed Staffing

Travel Nurse RN - Labor/Delivery - $1,955 per week in Whiteville, NC Job at TotalMed Staffing

We are seeking a Registered Nurse-Labor and Delivery for a travel assignment in Whiteville North Carolina.