The Head of Pharmacology and Toxicology Job at Gan & Lee Pharmaceuticals, Bridgewater, NJ

K0M3WWdTTzR1bzF6WU5lYkdVVWk1WThOR3c9PQ==
  • Gan & Lee Pharmaceuticals
  • Bridgewater, NJ

Job Description

Job Description:
The Head of Pharmacology and Toxicology is responsible for developing the strategy for pharmacology and toxicology studies of new drugs, leading safety assessments, and ensuring that safety evaluations comply with international standards. This role involves collaborating with cross-functional teams and CROs to integrate toxicology findings into development strategies.  
Key Responsibilities:
  • Provide pharmacology and toxicology assessment strategies, design and oversee nonclinical toxicology and safety pharmacology studies, review and finalize protocols and reports, and manage the studies with collaborators and CROs as needed.
  • Analyze, interpret, and summarize nonclinical safety and toxicology data and present data to internal project teams and leadership while providing strategic guidance and interpretation.
  • Author and review nonclinical sections for all regulatory filings including IND, CTA, BLA, NDA, IB, etc, with a focus on toxicology and pharmacology.
  • Lead the evaluation and selection of CROs and act as the main point of contact for non-clinical research communication while continuously tracking study progress to assess the performance of CROs.
  • Mentor junior team members and contribute to the long-term vision for the Nonclinical team.
  • Collaborate closely with clinical development teams, integrating toxicology data into strategic decisions.
  • Represent preclinical studies on project teams and interface with internal stakeholders, as well as with external stakeholders and regulatory agencies.
Qualifications:
  • PhD in pharmacology, toxicology, pharmacokinetics, pharmacodynamics, or related fields. DABT strongly preferred.
  • At least 8 years of experience in pharmacology and toxicology research and management in pharmaceuticals, biotechs, and CROs.
  • Proven expertise in toxicology study design, execution, and related regulatory strategies.
  • Excellent communication and team management skills, with the ability to coordinate cross-departmental resources.
  • Experience in team management and CRO management.

Job Tags

Full time,

Similar Jobs

Rackley Roofing

Commercial Roofer Job at Rackley Roofing

 ...Focused, Innovative, and Smart. These are the foundation of Rackley Roofing Companies. If you share the values, you belong in our Company....  ...join our great group of people at Rackley Roofing. Commercial Roofer Responsibilities: Commercial Roofers & Laborers *... 

The Recap Group Inc.

YouTube Associate Video Editor Job at The Recap Group Inc.

 ...that works with global media companies such as Fremantle and ITV - producers of beloved talent shows like Americas Got Talent, The Voice and more. We are redefining how legacy television content finds new life in the digital age. By combining creative ingenuity with... 

Hallmark Aviation Services

Flight Operations Manager in SFO Airport starting at 70K Job at Hallmark Aviation Services

 ...Flight Operations Manager in SFO Airport starting at 70K Tracking Code SFO OPS Job Description The Flight Operations Manager is...  ...Required Skills ~5 years flight operations experience with an international airline account(s) preferred ~ Proficient knowledge of... 

KMG Hotels

Laundry Attendant Job at KMG Hotels

 ...looking for a motivated, reliable individual to fill our full-time laundry attendant position. Job Details: It will be 5 days a week,...  ...We do offer Employee and friends and family discounts on hotel stays and Holiday pay. We offer insurance as well. PTO... 

Summit Leadership Partners

Senior Consultant Job at Summit Leadership Partners

 ...Duties and Responsibilities: The Senior Consultant will play a key role across a variety of...  ...and procedures Education and/or Work Experience Requirements: ~ Advanced...  ...~ Willingness to travel and work from home in a self-directed manner ~ Excellent...