Toxicologist, Cell

Position: Toxicologist

Department: Cell and Gene Therapy

FLSA status: Exempt

Location: Carlsbad, CA

Position Description:

We are seeking a highly skilled and experienced Toxicologist to join our team of experts. The ideal candidate will play a critical role in leading and managing toxicology studies as a senior study director within CGT department, ensuring the safety of products and substances, and providing expert toxicological guidance to clients. As a Toxicologist, you will be responsible for designing, overseeing, and interpreting toxicology studies, leading a team of scientists, and serving as a key point of contact for clients.

Key Responsibilities:

• Lead the design and planning of toxicology studies, including selecting appropriate study models and endpoints.
• Develop study protocols, timelines, and budgets in collaboration with project teams.
• Provide technical expertise and guidance to study teams throughout the planning, execution, and delivery phases.
• Monitor study progress, ensuring adherence to protocols and regulatory standards.
• Address any deviations or issues promptly and effectively.
• Analyze and interpret study data, draw meaningful conclusions, and make recommendations.
• Prepare comprehensive toxicology reports for clients and regulatory submissions.
• Act as the primary subject matter expert for clients, addressing their toxicology-related inquiries and concerns.
• Collaborate with clients to understand their needs and provide strategic toxicology advice.
• Stay current with relevant regulatory guidelines and ensure that studies are conducted in compliance with applicable regulations (e.g., FDA, EPA, OECD).
• Support regulatory submissions and interactions as needed.
• Lead a team of research scientists, providing guidance and mentorship.
• Interface with different teams, including in vivo scientists, QC/QA, Account Managers/Sales, and the veterinary staff.
• Foster a collaborative, positive and innovative work environment.

Qualifications:

• Ph.D. in Toxicology, Pharmacology, or a related field.
• A minimum of 8 years of experience in toxicology, with a strong track record in designing and overseeing toxicology studies.
• Demonstrated expertise in regulatory toxicology and compliance.
• Excellent written and oral communication skills.
• Leadership and team management experience.
• Strong problem-solving and critical-thinking abilities.
• Ability to work effectively in a fast-paced, collaborative environment.
• Board certification in toxicology (e.g., DABT).
• Experience with GLP (Good Laboratory Practice) and non-GLP toxicology studies.
• Previous experience in a CRO or pharmaceutical/biotechnology industry.
• Knowledge and experience in cell and gene therapy programs is preferred.

Benefits:

Pharmaron cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:

• Medical, Dental & Vision Insurance Plan with Employer Contribution
• Health Reimbursement Account Funded by Employer
• Healthcare & Dependent Care Flexible Spending Accounts
• Employee Life and AD&D Insurance 100% Employer Paid
• Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren)
• Short and Long Term Disability 100% Employer Paid
• 401k with Employer Match
• Employee Assistance Program

About Pharmaron

Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.

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