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

Tumblerware

Content Strategist Job at Tumblerware

 ...the intersection of creative, performance, and execution. Youll turn strong ideas into content systems that actually work, across social, email, site, and creators, while acting as the connective tissue during major launches and seasonal campaigns. If you love content... 

Yale New Haven Health

RN - Transplant/Surgical Services Job at Yale New Haven Health

OverviewTo be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals...

Rive

Sr. C++ Graphics Engineer Job at Rive

 ...ready UI and graphics with rich interactivity and state-driven animation. We're on a mission to make hard-coded graphics a thing of the...  ...in a startup or small, nimble environment Location: U.S. Remote, with the ability to work core hours centered around Pacific time... 

Syracuse Dunbar Avoca Public Schools

Curriculum & Assessment Coordinator Job at Syracuse Dunbar Avoca Public Schools

 ...Avoca Public Schools, an Excellent rated district, is seeking a Curriculum & Assessment Coordinator to support instructional improvement...  ...and teaching staff to align curriculum, analyze student data, develop and support professional development, leading the school... 

Ensono

PeopleSoft Senior FSCM Techno Consultant - AMS Job at Ensono

At Ensono, our Purpose is to be a relentless ally, disrupting the status quo and unleashing our clients to Do Great Things ! We enable our clients to achieve key business outcomes that reshape how our world runs. As an expert technology adviser and managed service provider...