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

Victor Valley College

Part-Time Faculty, Notary Public (Non-Credit) Job at Victor Valley College

 ...of transcripts showing college degrees and course-work. NOTE: Degrees must be from an accredited institution. *Applicants with foreign transcripts must have transcripts evaluated for U.S. equivalency by one of the following agencies. This evaluation must be completed... 

Air Sea Packing Group

Art Handler Job at Air Sea Packing Group

 ...Art Handler If youre looking to grow in the world of fine art logistics and you have a passion for it, then we just may have the perfect role for you! We are seeking a talented and driven Art Handler to join our organization. The ideal candidate will be a dynamic... 

BLR | Leadership Platforms | CCMI

Marketing Manager Job at BLR | Leadership Platforms | CCMI

 ...improvements in product adoption, customer retention, and upsell pipeline in collaboration with Product Management and Sales Enablement....  ...profile, segmentation, and buyer journey insights Manage surveys and reviews, build case studies, and develop award submissions... 

Freedom Laser Therapy, Inc.

Art Director Job at Freedom Laser Therapy, Inc.

 ...effective solutions for improving health and beauty. We are at an inflection point in our growth curve and are searching for an Art Director to join us on our journey to become a major global beauty brand. About The Position We're looking for a hands-on... 

Courtney Manor

Registered Nurse (RN) - Sign On Bonus Job at Courtney Manor

 ...critical thinker, a skilled communicator and passionate about caring for seniors? Are you seeking career advancement? As a Registered Nurse (RN) at Courtney Manor, you have the opportunity to use your nursing skills and become a leader.At Ciena Healthcare, we take care...