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

VjlSQTBlNEFXWi9ldlhZamt1blUvaDRGb3c9PQ==
  • Gan & Lee Pharmaceuticals
  • Bridgewater, NJ

Job Description

Job Description

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.

Powered by JazzHR

LQeK5vPaxN

Job Tags

Similar Jobs

Stake Recruiting

Online Game Tester Job at Stake Recruiting

 ...will play a crucial role in ensuring the continuous operation of online games released to the public. Duties: Test different...  ...Safari, Edge, etc.) Ability to do online research (i.e. google searches, etc.) Ability to create testing strategies (or find them online... 

Avera Health

Medical Laboratory Scientist (MLS) or Medical Laboratory Technician (MLT) or Microbiologist Job at Avera Health

 ...between 5:30 am - 7am with an 8 hour shift; Rotate every 3rd weekend/holiday; occasional on call; 80 hours every 2 weeks Medical Laboratory Technician Education & Certification Requirements: Associate's Transcript showing Medical Laboratory Technician degree MLT -... 

REI Systems

Federal Program Manager with Department of Transportation experience Job at REI Systems

 ...REI Systems mission is to deliver reliable, innovative technology solutions that advance Federal clients' missions and exceed their expectations. Our technologists and consultants are passionate about solving complex challenges that impact millions of lives. We take a... 

Iowa City Landscaping & Garden Center

Landscape Maintenance Job at Iowa City Landscaping & Garden Center

 ...Iowa City Landscaping & Garden Center in Iowa City, IA is currently seeking hard working men and women to add to our Landscape Maintenance team. Seasonal (March - November) full time positions available. Typical work days are 8:00 - 4:00 Monday thru Friday. Fill out... 

Washington International School

Upper School Principal - start date July 2025 Job at Washington International School

Job SummaryReporting to the Associate Head of School, the Upper School Principal is a member of the senior leadership team and is responsible for the successful implementation of the Upper School academic program, overseeing the social and emotional support of students...