MapLight Therapeutics

Title: Quality Systems Specialist Location: Burlington, MA Work Type: Hybrid Job Description: 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: The Quality System Specialist will support the continued development and manufacturing of MapLight products. Reporting to the Senior Manager, Quality Systems, QA, this role plays a key role in supporting the GMP Quality Management System to ensure compliance with applicable GxP regulations, company policies, and standard operating procedures. This position focuses on maintaining robust electronic quality systems, including (but not limited to) managing controlled documentation, archiving, and training Responsibilities: - Manage the full lifecycle of controlled documents, including creation, revision, approvals and archival within the electronic Quality Management System (ZenQMS). - Ensure that controlled documents, such as SOPs, Policies, etc are accurate, current and compliance with regulatory and internal requirements. - Collaborate/Coordinate workflows with internal stakeholders to ensure timely completion and alignment of documentation / metadata with procedural requirements. - Provide day-to-day support to employees on document control and quality system processes. - Author/support the creation, review, and modification of Standard Operating Procedures (SOPs), Work Instructions (Wis), and supporting documentation. - Support QA onboarding of all employees/contractors - Support management of deviation, CAPA, change control within QMS. Qualifications: - Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmacy) or a related field or equivalent work experience. - Minimum of 5 years of experience in the biotechnology or pharmaceutical industry - Understanding of FDA, EMA, and ICH guidelines and regulations. Familiarity with GCP, GMP, and GLP standards. - Excellent attention to detail, organizational, communication, and problem-solving skills, ability to manage multiple priorities in a dynamic environment. Strong knowledge of Microsoft Office Suite. - Experience with electronic quality management systems (eQMS) is strongly preferred. Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA. Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include 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, and parental leave. Salary Range $100,000 - $125,000 USD 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.

Title: Director, Biostatistics Location: Burlington, MA 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: MapLight is looking for an experienced and resourceful Director, Biostatistics. Reporting to Senior Director, Biostatistics, this role will be responsible for the statistical aspects of assigned clinical projects. This is a hands-on role where you will work with internal and external cross-functional study teams, support interaction with Health Authorities, and manage CRO for statistical related deliverables. Responsibilities: - Provide/validate sample size/power calculation and author statistical section of the protocol. - Responsible for the development of study SAP and table/figure/listing shells including overseeing CRO’s work. - Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Regulatory and other functions to meet project deliverables and timelines. - Provide statistical and strategic inputs in documents prepared for regulatory interactions. - Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables. - Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results. - Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations. Qualifications: - PhD in biostatistics or related discipline with 7+ years, or Master's Degree with 10+ years of experience in the pharmaceutical or biotech industry. - Demonstrated ability and experience in the design, analysis and reporting of clinical trials. - Knowledge of design considerations. Familiarity with CNS endpoints and associated analysis methodologies highly desirable. - Extensive knowledge of FDA, EMA and ICH regulations and industry standards applicable to the design and analysis of clinical trials and regulatory submissions. - Proficient in statistical programming (SAS and R). Experience with trial design software (e.g., EAST). - Ability to concurrently lead statistical efforts for multiple projects. - Understanding data standards, including SDTM and ADaM. - Adept at overseeing statistical services provided by CRO's. - Excellent verbal and written communication skills; Ability to communicate statistical information to non-scientists, willingness to educate internal team. Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA. Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include 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, and parental leave. Salary Range $195,000 - $245,000 USD 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.

Support clinical operations by managing trial documentation, coordinating meetings, and assisting with regulatory compliance. Engage with site staff and vendors to ensure effective communication and project execution throughout all phases of clinical...

• Be responsible for the operation and administration of the company’s contract management system, acting as the key point of contact for the business • Coordinate and assist in developing policies, procedures and systems to support and facilitate efficient contract development and analysis • Draft, review and negotiate a variety of day-to-day contracts, including non-disclosure agreements, master service agreements, consulting agreements, manufacturing and supply agreements, clinical trial agreements and other clinical documents, independently and with limited supervision • Negotiate to conclude agreements as efficiently as possible while meeting client needs and safeguarding MapLight’s interests • Effectively manage outside vendors, including working with and supervising outside counsel, as required • Create, improve, and implement applicable forms, templates, processes, and procedures to improve efficiency • Obtain and maintain a strong working knowledge of the Company’s business, scientific capabilities, and key strategic business objectives

Title: Associate Director, Medicinal Chemistry Location: Burlington, MA Job Description: 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 searching for a highly motivated Medicinal Chemist to join our drug discovery team at the Associate Director level. Reporting to the Senior Director of Chemistry, the candidate will be expected to co-lead, or lead, preclinical medicinal chemistry programs from hit to candidate nomination. A highly qualified candidate will have experience in CNS drug discovery and an in-depth understanding of designing efficacious and safe brain-penetrant small molecules. While MapLight has in-house laboratories for pre-clinical research, many activities like chemical synthesis are outsourced to external vendors. Experience managing remote CRO teams, logistics across multiple partners, and coordinating internal drug discovery activities across different time zones is essential. This is a fantastic opportunity to join a small medicinal chemistry team and have a significant impact in addressing unmet patient needs by advancing MapLight’s pipeline. Responsibilities: - Co-lead, or lead, preclinical medicinal chemistry programs from hit to candidate nomination. - Design and execute successful medicinal chemistry strategies to meet project and corporate goals. - Conduct multi-parameter optimization to deliver orally bioavailable, brain-penetrant candidates without secondary pharmacology, ADME, or safety concerns of initial hits. - Apply structure-based drug design principles utilizing in-house resources and external computational partners. - Manage chemistry and tiered screening cascade at external contract research organizations (CROs). This includes maintaining a good relationship, overseeing synthesis or experimental plans, project tracking, evaluation of results, and assisting in troubleshooting. May require assessment of analytical data including NMR, LCMS, HPLC, UV-VIS, and DSC. - Apply previous experience with successful hit finding strategies to find novel chemical equity, including scaffold-hopping approaches. - Coordinate with in-house drug discovery team to ensure compounds are distributed in support of other disciplines. - Provide regular project updates to Leadership and Project Teams that include relevant updates. May include in-depth SAR, ADME, and PK analyses. - Co-lead, or lead, patent strategy to protect existing or novel chemical matter with Maplight legal partners, when appropriate. - You can participate and work effectively with multiple cross-functional teams. - You have strong interpersonal skills and understand relationships are key to being successful. - You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others. - You’re a team player who is willing to roll-up your sleeves and get the job done. Qualifications: - PhD in Chemistry or Medicinal Chemistry with 10+ years’, or BS/MS 15+ years’, pharmaceutical experience successfully (co)leading preclinical drug discovery programs. - Contemporary knowledge of Medicinal Chemistry concepts with strong working knowledge of computational chemistry, biology, pharmacology, drug metabolism, and pharmacokinetics. - Prior experience in CNS drug discovery is essential, including a successful track record of delivering brain-penetrant candidate compounds for brain disorders. - Track record of successfully managing projects remotely through multiple and CRO partners. - Clear record of accomplishments as exemplified through patents and/or publications. Travel: Candidate can expect to travel 4-6 times a year to meet with collaborators and/or attend both discovery and all-company meetings. Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA. Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include 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, and parental leave. Salary Range $180,000 - $205,000 USD 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.

• Conduct market research and competitive analysis across therapeutic areas and pipeline assets • Support evaluation of business development opportunities, including partnerships, licensing, and M&A • Build and maintain financial models, forecasts, and valuation analyses • Prepare presentations and materials for executive leadership and board discussions • Analyze industry trends, clinical developments, and regulatory landscapes • Support clinical and commercial planning through primary and secondary research

• Ensure global clinical monitoring is executed with high standards of quality and consistency • Oversee Lead CRAs and provide support and guidance for their management of monitoring teams • Enhance the framework for clinical site monitoring and site management strategies • Oversee the Clinical Operations Systems team to support the continued development, efficiency and integrity of the eTMF and CTMS systems • Accountable to strengthen the monitoring, site management and clinical systems quality oversight strategy • Develop standardized key performance indicators (KPIs) and key quality indicators (KQIs) • Grow and develop team members in the clinical monitoring and operations systems team • Represents the monitoring and clinical operations system functions in senior management meetings

• Collaborate with colleagues on a matrix team to ensure the optimal planning, implementation, interpretation and reporting of clinical studies, including: • Contribute to the design of study synopses/protocols that will rigorously evaluate the efficacy and safety of compounds in development • Participate in vendor selection and study start-up processes and study-related plans • Monitor clinical studies, focusing on quality and adherence to Good Clinical Practice • Continually evaluate study data and study metrics, including eligibility criteria, trend analyses, outlier analyses, protocol compliance, deviations, and timelines • Partner with pharmacovigilance to review and report clinical safety data for presentation to key internal and external stakeholders, including management and Data Safety Boards • Interact with sites and CROs to support study awareness, patient recruitment, and quality of study conduct • Contribute to the preparation and review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans. • Participate in study start-up processes • Contribute to the writing of final study reports • Promote a high-performance culture and respectful work environment. • Comply with all applicable laws, regulations and regulatory guidelines as well as SOPs and ethical standards. • You can participate and work effectively with multiple cross-functional teams. • You have strong interpersonal skills and understand relationships are key to being successful. • You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others. • You’re a team player who is willing to roll-up your sleeves and get the job done.

• Lead the development and optimization of analytical methods for starting materials, intermediates and drug substances. Experienced with a wide range of techniques such as HPLC, GC, LC-MS, NMR, UV, FTIR, and other relevant analytical techniques to ensure method suitability for intended applications. • Design and lead method validation activities to ensure methods meet ICH, FDA, EMA, and other applicable regulatory guidelines. Oversee method development and transfer activities to manufacturing or quality laboratories, ensuring clear documentation and effective technology transfer. • Prepare, review, and approve technical documents such as standard operating procedures (SOPs), analytical study methods/protocols/reports, and product specifications. • Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/MAA) and support regulatory interactions as an analytical subject matter expert. • Collaborate with process chemistry scientists, development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle. • Lead or contribute to multi-disciplinary project teams, manage analytical development timelines and communicate progress to stakeholders.

• Lead development of small molecule solid-oral dosage formulations from pre-IND to Phase 3 including: • Assess API physical and chemical properties as it relates to drug product manufacturability, performance and stability • Evaluate phase-appropriate formulation approaches and enabling technologies to achieve the target drug product profile • Design experiments to optimize the formulation and manufacturing process • Oversee formulation development and GMP manufacturing activities at CDMOs: • Lead DP endor section activities as necessary ad manage vendor relationship • Effectively communicate scope of work, timelines, and priorities and monitor the deliverables and performance as it relates to the project objectives • Drive review of batch records, protocols, reports, and other vendor documents • Provide technical expertise and guidance to troubleshoot development and manufacturing challenges • On-site presence for batch manufacturing activities at the CDMO as needed • Represent formulation development group in cross-functional team and effectively communicate project status and technical risks with appropriate solutions • Work closely with QA to ensure GMP activities are conducted in accordance with internal QMS • Author/review internal technical reports and drug product sections of regulatory filings • You can participate and work effectively with multiple cross-functional teams. • You have strong interpersonal skills and understand relationships are key to being successful. • You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others. • You’re a team player who is willing to roll-up your sleeves and get the job done.