CHEManager International · 2 days ago
Scientist, Non-clinical Toxicology
Burlington, MA
Full-time
Hybrid
Mid, Senior Level
$127K/yr - $144K/yr
3+ years expMapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. They are seeking an experienced Toxicologist to design, execute, and interpret non-clinical safety studies supporting their neurology drug discovery and development programs.
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Responsibilities
Collaborate with program team leads and subject matter experts (e.g., discovery, bioanalysis, pharmacokinetics, CMC) to design safety pharmacology and toxicology studies, aligning with company objectives and regulatory standards
Serve as the primary sponsor representative for CROs, handling all aspects of study outsourcing, including requesting quotes, negotiating contracts, and managing study timelines
Oversee the design, execution, and data interpretation of nonclinical safety studies conducted at CROs, ensuring robust and high-quality data generation
Review study reports and SEND datasets to ensure quality, timeliness, and readiness for regulatory submissions
Effectively communicate study findings project leads and senior management, addressing and resolving any study-related issues promptly
Contribute to the preparation, review, and/or QC of nonclinical sections in regulatory submission documents (e.g., IBs, INDs, CTAs, NDAs, PIPs, Scientific Advice, annual reports, briefing documents) as needed
Participate in issue-resolution teams, providing scientific guidance to address toxicology-related challenges and drive effective problem-solving
Qualification
Required
PhD with 3+ years, MS with a minimum of 5+ years, or BS with a minimum of 8 years of hands-on experience as a study director in toxicology within the pharmaceutical or biotechnology industry or at CROs (additional experience monitoring studies on-site at CROs is helpful)
Proven track record of successfully directing and/or monitoring toxicology studies across various modalities and in various species (rodent, dog, nhp)
Advanced knowledge of toxicology in support of drug development; Board Certification in toxicology (DABT Certification) or working towards board certification preferred but not required
In-depth understanding of GLP regulations and regulatory guidance for nonclinical evaluations
Demonstrated enthusiasm for scientific research and a commitment to maintaining high-quality standards in toxicology study operations
Strong critical thinking, analysis, and leadership skills
Self-motivated to meet performance objectives and to prioritize job-related tasks!
Ability to adapt to dynamic project needs and manage studies across different time zones
Excellent interpersonal, communication, and negotiation skills, with a collaborative mindset!
Willingness to travel on business to CROs as needed
Preferred
Board Certification in toxicology (DABT Certification) or working towards board certification
Benefits
Annual bonus opportunity
Medical
Dental
Vision
Life and AD&D
Short term and long term disability
401(K) plan with match
Stock options
Flexible non-accrual paid time off
Parental leave
Company
CHEManager International
Wiley’s leading media brand providing first-hand information on the global chemical, life science and process industries
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase