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.
Qualifications:
- 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
Location: This is a hybrid position with three days on site at our office in Burlington, MA.
EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
