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

NmR0WEJHYnF5WXMvK0FWRmtuazdDT2g3UVE9PQ==
  • 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

Comfort Inn Bozeman

Breakfast Server Job at Comfort Inn Bozeman

 ...professional with a strong desire to provide excellent customer service to guests? You might be just what we're looking for in our next breakfast attendant. Our busy hotel is looking for a detail-oriented person to set up and take down our breakfast buffet, ensuring that... 

Gridlines

Remote Project Finance -Senior Manager Job at Gridlines

 ...Operations: Managing a portfolio of active assignments. Lead in the creation and...  ...ensure consistency. Lead in developing project plans, timelines, and resource allocation...  ...to work independently and as part of a remote team. Benefits A competitive... 

City National Bank

Mortgage Loan Closer II Job at City National Bank

*MORTGAGE LOAN CLOSER II*WHAT IS THE OPPORTUNITY?The Mortgage Loan Closer II is responsible for coordination of all steps of the loan closing and preparing documents to transmit to the settlement agent in a timely manner. WHAT WILL YOU DO?* Ensures file and documents...

EXCEPTIONAL HOME CARE

Registered Nurse (RN) Los Angeles County PART TIME Job at EXCEPTIONAL HOME CARE

We are looking to hire Part-Time Registered Nurses with 2 years of RN experiences for Case Management within the same Los Angeles and Orange County areas. RN's will be in charge of admitting new patients into the agency, doing head to toe assessments, document changes in... 

TRYP by Wyndham Pittsburgh/Lawrenceville

Breakfast Server - Barista Job at TRYP by Wyndham Pittsburgh/Lawrenceville

 ...for an enthusiastic and detail-oriented customer service professional to make our guests' dining experience memorable. As our breakfast server/barista, you make coffee and beverages as needed while taking food orders. Candidates should be enthusiastic about customer service...