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

Silencer Central

Front-End Developer Job at Silencer Central

 ...work and passion of our team members, and they unite our business and customers. The Front-End Developer is responsible for building the visual and interactive elements of websites and web applications the parts users see and interact with. They work with designers,... 

PRACTICE

Spanish-English Biology Tutor Job at PRACTICE

 ...a Bilingual Education Champion ! Here's Why You'll Love This Role: About the Job: Were hiring dedicated in-person Spanish-Speaking tutors to provide support in Biology . In this role, you will work closely with teachers to co-plan and deliver targeted instruction... 

Nino Salvaggio International Marketplace

Janitorial Associate Job at Nino Salvaggio International Marketplace

 ...location. RESPONSIBILITIES: Properly, thoroughly and completely clean and sanitize all store restrooms (sinks, counters, mirrors,...  ...transportation. Must be able to work early mornings, nights and weekends. Ability to solve practical problems as they relate... 

GreatAuPair LLC

Personal Assistant Job at GreatAuPair LLC

 ...assist in food prep, light cleaning, and light caregiving. Both elders, husband and wife, are in late 70s/early 80, and want to remain living independently. These tasks are currently a few hours a day, although they may increase as the elders age. We can pay full time... 

Summit Leadership Partners

Principal Consultant Job at Summit Leadership Partners

 ...Duties and Responsibilities: Principal Consultants manage key clients and lead complex...  ...policies and procedures Education and/or Work Experience Requirements: ~ Advanced...  ...~ Willingness to travel and work from home in a self-directed manner ~ Excellent...