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Scientist, Non-clinical Toxicology
About the position Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll Do: We are seeking an experienced Toxicologist to design, execute, and interpret non-clinical safety studies supporting our neurology drug discovery and development programs. This role will play a critical part in candidate selection, IND-enabling activities, and regulatory submissions, working closely with discovery biology, DMPK, CMC, and clinical teams. The ideal candidate brings hands-on toxicology expertise, strong scientific judgment, and experience with CNS-relevant safety considerations. 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. Requirements • 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 Nice-to-haves • Board Certification in toxicology (DABT Certification) or working towards board certification preferred but not required. • additional experience monitoring studies on-site at CROs is helpful 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 Apply tot his job Apply tot his job
