What You’ll Do:

An exciting new opportunity has opened up for a Contracts and Legal Systems Manager to assist with our day-to-day legal systems and contracting needs, including for clinical trials, supply, commercial, finance, and other key contracting areas.  Reporting to the Company’s Sr. Director, Corporate Counsel, this individual will play a key role in a growing legal team, with many opportunities to grow their career with the company.

The ideal candidate should have significant experience working with contracts management systems, including acting as the key legal point of contact for business users, training clients, and managing contracts workflows within a cross-functional team. The ideal candidate should also have significant experience drafting, negotiating, and managing agreements for clinical and commercial-stage pharmaceutical and life sciences companies, including non-disclosure agreements, master services agreements, consulting agreements, manufacturing and supply agreements, clinical trial agreements, and other commercial agreements.  Experience as a corporate paralegal or legal support analyst at life sciences companies or law firms is considered a plus.

The successful candidate must be able to take ownership of the legal function’s role in a company’s legal, procurement, and financial systems architecture, as well as work independently to draft, revise and negotiate agreements, with a flexible and collaborative approach.

Responsibilities:

• 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

Other Skills and Abilities:

• Solid business judgment and strategic thinking. Ability to recognize risk and develop practical, workable strategies to mitigate such risk
• Flexibility and willingness to work on a broad variety of matters
• Strong written and oral communications skills required to work both internally and externally.
• Ability to independently work with minimal day-to-day oversight
• Ability to meet deadlines while managing a substantial workload in a fast-paced environment
• Ability to engender confidence when advising clients at all levels
• Ability to work with the highest level of integrity
• Willingness to travel when required

Qualifications:

• Bachelor’s degree with a minimum of 5 years of progressive responsibility with recent experience in contract negotiation, administration and/or management
• Experience with pharmaceutical and life sciences companies
• Familiarity with design and administration of contracts management systems (e.g., Ariba, Coupa, Concur, NetSuite)
• Paralegal certification or equivalent legal education or training is considered a plus
• Comprehensive computer skills including Microsoft Office

Key MapLight Behaviors:

We consider these behaviors we seek in all MapLight employees.

• 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.

Location: Candidates for this role must be within commuting distance of MapLight’s Burlington, MA office.

Travel: Minimal travel (1-2 times per year) is expected.

What You’ll Do:

Reporting to the VP of Clinical Operations the Lead Clinical Research Associate will oversee an assigned MapLight study monitoring team to ensure monitoring quality and excellence in line with MapLight’s Mission, Vision, and Values. This role will maintain site management and monitoring responsibilities for assigned sites in addition to study team level work. This role will collaborate closely with key cross-functional internal stakeholders, Clinical Operations, Clinical Development, Medical Monitoring, Data Management, Supply Chain, and Clinical Compliance and Quality as well as external CRO and vendor partners to ensure quality of monitoring conduct and oversight from study start up through close out. This is a highly collaborative and dynamic role within a fast paced and results-oriented environment.

Responsibilities:

• Lead and manage a team of Clinical Research Associates.
  • Provide line management for CRAs inclusive of performance management and career development.
  • Ensure CRAs are trained and maintain compliance with internal procedures and processes and regulatory requirements (GCP).
  • Support the Clinical Operations study team with CRA resourcing.
• Maintain site management and monitoring responsibility for at least one site for the assigned study(ies).
  • Prepare for and conduct Pre-Study, Initiation, Interim and Closeout monitoring visits in accordance with MapLight SOPs and procedures, regulatory requirements and industry guidelines and best practices (ICH GCP).
  • Support the study team in meeting study milestones (site activation, DSMB meetings, database lock, etc.).
  • Perform centralized monitoring activities between on-site visits to ensure timely resolution of action items, oversight of study data quality and flow, and proactively identify and mitigate/manage study risks and issues.
  • Maintain quality and compliant documentation related to all aspects of site management including quality and ALCOA+ compliant monitoring visit reports, centralized monitoring reports, site contact reports, Trial Master File/Investigator Site File, etc.
  • Serve as the main MapLight point of contact for Investigator sites to support protocol compliance, streamlined communications, timely responses to site staff needs, and training needs.
  • Support the study team and Investigator sites during inspections or audits, as needed.
• Support the study team(s) in development of study-specific monitoring procedures.
  • Develop and maintain the study monitoring plan, templates, and tools.
  • Recommend and implement appropriate monitoring strategy based on study design, recruitment goals and the needs of the study.
  • Maintain current knowledge of regulatory requirements and industry best practices related to monitoring, including centralized monitoring and risk-based monitoring.
• Act as a core member of the cross-functional study team.
  • Participate in study team meetings as a subject matter expert on monitoring processes.
  • Take a proactive and innovative approach to risk and issues management as related to monitoring quality or strategy.
  • Recommend and implement process changes related to monitoring to support study goals and timelines.
  • Support the study team in the integration of the monitoring function in study management (feasibility, site activation, site communication, risk management, etc.)
  • Support the study team and Investigator sites during inspections or audits, as needed.
  • Accomplish other tasks as assigned.
• Provide oversight of study monitoring
  • Review monitoring visit reports to ensure MapLight quality standards are met.
  • Review Key Performance Indicators for assigned CRAs to ensure high performance and compliance with requirements.
  • Perform oversight visits and co-monitoring visits to ensure quality monitoring.
• Support development and process improvement for the MapLight monitoring function.
  • Support development and revision of SOPs, processes, templates, tools, and plans with the aim of continual improvement and streamlining.
  • Maintain a forward-thinking approach to monitoring process to support department and corporate growth and change.
  • Contribute to the maintenance and improvement of clinical systems to drive process improvement and efficiency.
• Embody and demonstrate MapLight’s core values of Integrity, Collaboration, Bravery, and Dedication.

Qualifications:

• Bachelor’s degree in a relevant field or RN; approximately 7+ years in the clinical trial industry with at least 5 years of clinical monitoring including complex therapeutic areas, in-patient trials, and blinded trials. (Recent CNS and/or neuropsychiatry, specifically in-patient schizophrenia and Alzheimer’s disease psychosis experience, strongly preferred.)
• Experience working in small/emerging biotech a plus
• Experience managing a clinical monitoring team at a pharmaceutical or biotech company or CRO.
• Demonstrated ability serve as a role model and mentor to more junior clinical staff.
• Ability to build relationships between Investigator sites and MapLight to foster strong collaboration, trust, and positive working relationships.
• Ability to engage collaboratively with internal and external stakeholders in a professional manner.
• Strong interpersonal, oral, and written communication skills.
• A self-starter with the ability to work independently and proactively.
• Willingness to be a “team player” and take on additional responsibilities as requested.
• Strong working knowledge of Good Clinical Practices (GCPs), ALCOA+, and pertinent regulations.
• Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
• High attention to detail and focus on quality and compliance in all aspects of assigned work.
• Experience working in various clinical software systems (CTMS, eTMF, RIM).
• Proficiency with Word, Excel, PowerPoint, and Microsoft Office.
• Ability to travel independently by air, car and/or train. Location near a major airport preferred.

Travel:

• Position will require up to 30-40% travel with potential to be higher at times of peak study activity. Additional periodic travel for meetings is expected.

What You’ll Do: 

The Safety Scientist will be responsible for high quality safety surveillance activities including medical review of individual case safety reports (ICSRs), aggregate report production, safety governance meeting coordination, safety signal detection and assessment, and safety risk management activities for assigned products. This individual will collaborate with Program Safety Lead and other program team members, pharmacovigilance operations, and CROs to ensure proactive safety surveillance in compliance with global regulations. 

Responsibilities:

• Manage safety surveillance and signal detection activities (period review of aggregate safety data, safety surveillance team meetings, track signals and related documentation)
• Represent PV at clinical study team for assigned product
• Develop signal assessment report under the oversight of Program safety lead for validated safety signal
• Collaborate with PV operations for timely and accurate medical review of ICSRs for assigned clinical study as needed
• Develop and contribute safety risk management plan across product lifecycle
• Develop and manage periodic reports (DSUR/PBRER)
• Contribute for data analysis and authoring of safety sections for regulatory submissions and regulatory responses
• Contribute for the development or updates of safety surveillance and risk management SOPs, templates etc.
• Collaborate with clinical study teams on safety surveillance deliverables (IB, RSI, Protocol, Briefing documents etc.)
• Participating in PV audit and inspections
• Represent Pharmacovigilance function in committees and activities both internally and externally when appropriate.

We consider these behaviors we seek in all MapLight employees.

• You can participate and work effectively with multiple cross-functional teams.
• You have strong interpersonal skills and understanding 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:

• Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science.
  • Preferred: Post-graduate training in epidemiology (e.g. MPH)
• Minimum 10 years of pharmacovigilance experience within the biopharmaceutical industry with at least 3 years of direct clinical/patient care experience
  • Preferred: Safety surveillance and risk management experience in neuroscience, psychiatry or neurodegenerative disease area
• Competence in conducting safety data reviews, preparation of aggregate reports, signal detection and risk management plans for investigational and/or post-marketed products
• Experience with MedDRA and drug coding reviews
• Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes
• Experience in PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections
• Exceptional communication and cross-functional collaboration skills
• Strategic thinker with the ability to translate complex safety data into actionable insights for regulatory and clinical decision-making
• Able to work within a growing organization and to help the organization evolve over time
• Able to engage in an open, constructive and continuous dialogue with the Company’s stakeholders based on equality and mutual respect
• Highly motivated, self-driven and dependable
• Committed to MapLight's Core Beliefs and Values

Location:   This is a remote US position.  Hybrid 3 day in office policy for anyone located within 50 miles of Redwood City, CA or Burlington, MA.  

Travel: Ability to travel as needed (up to 10%) for corporate and departmental meetings.

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.

What You’ll Do:

The Senior Clinical Trial Associate (Sr. CTA) is required to help support Clinical Operations and project teams. The position offers much responsibility and the opportunity to be involved in all phases of the clinical project. The position requires adaptability and the capacity to ‘own’ tasks, problem solve and to see activities through to their end. 

Responsibilities:

• Interact directly with Clinical (e.g., CRAs, trial managers), site staff, vendors (U.S. and worldwide, as necessary), to provide support in project-specific tasks and the overall management of clinical trials
• Directly support under the guidance of Operational Leaders, Clinical Leaders, and Clinical Trial Managers. Specific responsibilities include:
• Maintain and manage requests for access to and deactivation of study systems users.
• Coordinates materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetings, including requests for materials from external consultants, suppliers, etc.
• Distribute safety alerts and relevant documents, if required
• Maintain and update study team and vendor contact information
• Assist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates
• May participate in reviewing, formatting and finalizing study-related templates, plans and manuals
• Assist with maintaining clinical trial insurance
• Assist with questions, issues or requests from the Clinical Research Organization (CRO)/study team and route to the appropriate individual within the organization for resolution
• May participate in clinical data review, as required

• Responsible for the completeness of documents managed in the Trial Master Files (TMF); performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs and ICH GCP Guidelines

• Route, track and file Clinical documents. May conduct initial/ongoing review of site Clinical regulatory documentation to confirm completeness/track dates and distribute to appropriate team members for review
• Develop and maintain study-related trackers that will support Clinical Operations and individual studies. May analyze or update data associated with the trackers
• Other duties as assigned to support Study Team Leads and Operational Team Leads

Qualifications:

• Bachelor’s degree in a relevant subject area is highly recommended or a combination of education and applicable job experience may be considered.
• Minimum 2+ years in the biotech /pharmaceutical industry /clinical trial management area
• Competency of the drug development process with knowledge of ICH-GCP is a plus
• Strong interpersonal, organizational and planning skills along with excellent verbal and written communication skills
• Proactive and self-starter with the ability to take responsibility for tasks and execute seamlessly. Be able to identify areas for efficiency across studies in the spaces that the position is responsible for.

Travel:

• Ability to travel up to 35%

Location: 3 day hybrid in office in Burlington, MA

Maplight is anticipating two Ph2 readouts in Q3 2026

MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.

What You’ll Do:

MapLight is looking for a dynamic and experienced Senior Specialist, Clinical Business Operations.  Reporting to the Executive Director, Clinical Operations, the Senior Specialist will be responsible for supporting all aspects of clinical business operations, including vendor selection, contracts, budget management and performance metrics. The ideal candidate will streamline operational procedures across multiple projects to improve timelines and organization of data.

Responsibilities:

• Vendor selection; including review and analysis, budget negotiations, development, and execution.
• Manage the Request for Proposal (RFP) process. This includes:
  • Work with Clinical Trial Managers (CTM) and Clinical Scientific Leads to develop outsourcing strategy including range of vendors and timelines for award (i.e. schedule a vendor outsourcing strategy meeting).
  • Use the RFP template to customize to each study.
  • Create a draft of the RFP for review by the study team.
  • Communicate with vendors the RFP timelines and milestones and coordinate feedback to questions/answers.
  • Maintain the internal RFP timelines and milestones.
  • Following award, be the point of contact to receive the scope of work and budget grid from vendor.
  • Coordinate the review and consolidate the internal study team’s (and finance) questions and comments regarding the budget to the vendor.
  • Coordinate contract review and Coupa entry of budget.
  • Initiate a warm transfer to the operations team.
• Manage MapLight’s review of all site budgets and contracts. This includes:
  • Lead discussions with vendor and CTM to develop study budget and acceptable ranges.
  • Forecast site contract review timelines as they related to study start up with assistance from the study CTM.
  • Laise with the Legal Department to ensure MapLight specific site contract template with fall back language is acceptable.
  • Coordinate with CRO/vendor for process of escalation language to MapLight.
  • Coordinate with study team on internal process for triage of contract language and budget requests.
  • Provide and/or track contract status updates/reporting.
  • Ensure all executed site contracts are filed in the designated area within MapLight.
• Assist with and provide support in developing effective clinical contractual agreements (such as Confidentiality Agreements, Master Services Agreements, Work Orders, Amendments, Change Orders, and any other type of contracts) needed for clinical studies.
• Actively managing other clinical financial obligations.
• Facilitate creation and execution of all contract documents and manage the review and negotiation of contract terms and partner in collaboration with Legal, Finance and other internal stakeholders as needed to finalize.
• Builds and maintains business relationships and establishes partnerships with CROs, vendors, and other external partners including strategic partnerships and preferred provider relationships.
• Innovate and maintain tracking systems and metrics, translating complex data into actionable insights for project and program advancement.
• 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:

• Bachelor’s Degree or equivalent education required, preferably in Life Sciences, Finance, or Business Administration.
• A minimum of 3 years experience with outsourcing for clinical trials, vendor negotiations, or operations management, accounting, and finance.
• Experience working with the biotech/pharmaceutical industry at a CRO or sponsor company preferred.
• Experience working with key Clinical Operations stakeholders.
• Excellent written and oral communication skills with ability to generate concise reports and verbal updates.
• Demonstrated strong analytical skills.
• Demonstrated high level of proficiency with Microsoft Office suite (Outlook, Word, Excel, PowerPoint)
• Must be flexible and adaptable to changing project priorities, work assignments and deadlines.

 Location: 3 day hybrid in office position in Burlington, MA. 

MapLight is anticipating two Ph2 readouts in Q3 2026

MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.

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 Executive 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. 

What You’ll Do: Reporting to the VP of Clinical Operations, the Sr. Director of Clinical Monitoring and Operational Systems plays an integral role in the strategic development, oversight, and execution of global clinical monitoring and operational systems across MapLight’s entire clinical trial portfolio.  This role will develop forward‑thinking approaches to strengthen site relationships, guide the oversight of monitoring activities, and reinforce the organization's standing as a dependable and collaborative study sponsor.  Close collaboration with key cross-functional internal stakeholders, Clinical Operations, Clinical Development, Data Management and Clinical Compliance and Quality as well as external CRO and vendor partners is essential to ensure quality of monitoring conduct and oversight from study start up through close out. This is a highly collaborative and dynamic role within a fast paced and results-oriented environment. Applicants should be outstanding team members with the ability to effectively lead a team and to communicate with and influence both internal and external stakeholders with a passion for positive site relationships and clinical participant experiences.

Responsibilities:

• Ensure global clinical monitoring is executed with high standards of quality and consistency while maintaining compliance with GCP regulations whether monitoring done by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs).
• Oversee Lead CRAs, providing support and guidance for their management of monitoring teams; creates a culture of continuous learning for all levels of clinical monitoring team members.
  • Conducts oversight monitoring visits and/or co-monitoring visits where required
• Enhance the framework for clinical site monitoring and site management strategies and activities. Partners closely with Trial Managers and Data Management leaders in aligning these strategies
• Oversee the Clinical Operations Systems team to support the continued development, efficiency and integrity of the eTMF and CTMS systems and team members.  
• Accountable to strengthen the monitoring, site management and clinical systems quality oversight strategy, with the development and maintenance of SOPs, processes, tools and templates. Partner closely with QA to maintain a compliance framework.
• Develop standardized key performance indicators (KPIs) and key quality indicators (KQIs) for implementation with monitoring plans, eTMF inspection readiness, and processes. Lead where appropriate, and participate and support internal audit and regulatory inspection activities related to site monitoring and sponsor oversight
• Grow and develop team members in the clinical monitoring and operations systems team. Assist in the development of career pathways and standardized functional training.
• Represents the monitoring and clinical operations system functions in senior management meetings, where applicable. Supports the LCRAs, in partnering with Clinical Leads and Trial Managers to ensure appropriate monitor resourcing for clinical studies.

Qualifications:

• Bachelor’s degree in a relevant field; a minimum of 12 years in the clinical trial industry with at least 5 years experience onsite clinical monitoring
• A minimum of 5 years providing global trial monitoring oversight with direct management of monitors.
• Experience managing FSP/CRO monitoring teams and developing monitoring quality metrics, KPIs, with demonstrated focus on building processes, standardization and efficiencies.
• Demonstrated experience with a variety of CTMS and eTMF platforms
• Demonstrated ability to be versatile, serve as a role model to more junior clinical staff and a willingness to teach others as evidenced by a collaborative work style.
• Competency in technical systems that improve efficiencies (ex. Power BI).
• Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
• Deep working knowledge of ICH‑GCP, FDA, EMA, and other global regulatory requirements, and clinical operational standards.
• Demonstrated ability to attend to detail, make effective presentations and work independently.
• Ability to travel independently by air, car and/or train.

Travel:  Position may require up to 30% travel in an annual year

MapLight 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.

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 Director, Clinical Development, will be a highly qualified and motivated study director supporting ML-007 Schizophrenia Phase 2/3. This position reports to the Senior Vice President, Clinical Development, and will be an important member of cross-functional development teams.

Responsibilities:

• 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.

Qualifications:

• MD (Medical Doctor or equivalent)
  • Board eligible/certified preferred
  • Active license preferred
• Minimum 2 years industry experience in clinical research and medical monitoring.
• Excellent clinical judgment with thorough understanding of medical and clinical research norms and practices
• Methodical detail-oriented mindset with strong organizational abilities
• Proficient with computerized systems and electronic databases
• Demonstrated ability to work well within a geographically diverse team structure.
• Strong communication and presentation skills.
• Strong verbal and written command of the English language.
• Highly motivated, self-driven and dependable.
• Flexible availability, as needed for monitoring clinical trials
• Committed to MapLight's Core Beliefs and Values.

Travel:

• Ability to travel (approximately 10%).

Location: This is a remote US base position.  Employees located within a 50 mile radius of Redwood City, CA or Burlington, MA is hybrid in office.  

MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.

What You’ll Do: We are looking for an experienced and detail-oriented Clinical Quality Operations (QA) Director to ensure clinical trials are conducted according to Quality guidelines and regulatory requirements. Reporting to the VP, Quality, the Clinical QA Director works to lead the Clinical QA team and organization leadership to maintain Quality standards for our clinical trials.

Responsibilities:

• Management of Clinical Quality team and representing QA at internal and external Clinical meetings.
• Manage collaboration and support of Clinical Operations, Clinical Development, and Data Management teams
• Ensure that all processes contributing to the performance of a clinical trial are conducted according to ICH Guidelines and applicable regulatory requirements.
• Manage and maintain clinical non-protocol quality events in the quality system.
• Prepare and assist in preparing Quality management Review reports and quality trend reports.
• Contribute to Clinical Quality improvement programs.
• Evaluate quality events, incidents, queries, and complaints.
• Keep up to date with all related quality legislation and compliance issues
• Contribute materials for submission to regulatory agencies.
• Ensure regulatory rules are communicated through corporate policies and procedures.
• Utilize guidance documents, international standards, or consensus standards and interpret for guidance.
• Ensure that investigator, vendor, facility and system audits are conducted.
• Communicate any critical compliance risks noted from these activities to senior management/VP GxP Quality Assurance.
• Contribute to the preparation, conduct, and responses to regulatory agency.
• Support review of clinical trial material batch records.

Qualifications:

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmacy) or a related field.
• Minimum of 12 years of experience with Clinical Quality Assurance in the pharmaceutical industry
• Knowledge of applicable GCP regulations and industry guidance.
• Demonstrated ability to assess risk and prioritize effectively, with the ability to work with aggressive timeframes and adhere to project deadlines in a fast-paced environment.
• Keep current with changes to GxP, FDA, ICH, and OSHA requirements.
• Must have strong organizational skills and exceptional attention to detail.
• Able to work independently and as part of a team.

Location: This is a hybrid position with three days on site at our office in Burlington, MA.

What You’ll Do: 

The Senior Medical Director, Pharmacovigilance will lead the medical safety evaluation and benefit-risk assessment for products throughout their lifecycle with focus on patient well-being and compliance and applicable regulatory requirements. This person will lead cross-functional safety management team (SMT) and collaborate with other members Clinical Development and Medical Affairs (CDMA), contract research organizations (CROs), and drug development collaborators/partners to ensure that all clinical safety and benefit-risk assessment is performed adequately for assigned products. Reporting to the Vice President, Pharmacovigilance, the Senior Medical Director will oversee cross-functional teams and may have direct reports

 Responsibilities:

• Lead product safety surveillance and oversee evolving safety and benefit-risk profiles for assigned products.
• Lead cross-functional safety management team (SMT) for assigned products, and responsible for the on-going assessment of benefit-risk profiles and related actions during the product life cycle.
• Review safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products.
• Responsible for conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
• Represent pharmacovigilance on cross-functional product/project teams including review of safety sections of protocols, investigator brochures, informed consent forms, and other documents with safety content.
• Responsible for strategy and key content of Risk Management documents (DRMPs, RMPs, REMS) and regulatory responses.
• Provide strategy and guidance to safety risk management scientists in writing of periodic reports for assigned products; provide medical interpretation, review and approval.
• Responsible for up-to-date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents.
• Perform the medical review of all adverse event reports for seriousness, expectedness and causality.
• Coach, mentor and manage safety scientists supporting the surveillance activities for assigned products.
• Represent Pharmacovigilance function in committees and activities both internally and externally when appropriate.

We consider these behaviors we seek in all ML employees.

• You can participate and work effectively with multiple cross-functional teams.
• You have strong interpersonal skills and understanding 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:

• MD or equivalent with 3-5 years of relevant clinical experience
  • Preferred: Board Certified/Board Eligible in Neurology or psychiatry
• Minimum 10 years’ industry experience, within Drug safety/Pharmacovigilance with investigational and/or marketed products
  • Preferred: experience in NDA/IND submissions in neuroscience, psychiatry or neurodegenerative therapeutic area
• Proven experience in safety data analysis, signal management, and benefit-risk evaluation
• Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)
• Demonstrated ability to develop and implement drug safety strategies and risk management plans
• Proven experience with authoring or contributing to clinical study and regulatory submission documents
• Working knowledge of relevant local and global regulatory requirements and guidance documents
• Able to lead in a cross functional setting and work collaboratively with internal and external partners in a fast-paced environment
• Able to work within a growing organization and to help the organization evolve over time.
• Able to engage in an open, constructive and continuous dialogue with the Company’s stakeholders based on equality and mutual respect.
• Effective oral and written communication skills.
• Highly motivated, self-driven and dependable.
• Committed to MapLight's Core Beliefs and Values.

Location: This is a remote US position. 

Travel: Ability to travel as needed (up to 10%) for corporate and departmental meetings.

MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.

What You’ll Do: We are seeking a highly motivated and experienced Principal Scientist to lead analytical development efforts for small molecule drug substances. This role will support early to late-stage development programs and ensure robust characterization, method development, and regulatory compliance to advance our pipeline through clinical and commercial success.

Responsibilities:

• 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.

Qualifications:

• PhD. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or related field with 5+ years of relevant industry experience; or M.S. with 7+ years; or B.S with 10+ years.
• Experience with analytical development in the pharmaceutical, biotechnology or CRO/CMO industry including direct experience with regulatory submissions and GMP/GLP environments.
• Direct experience working with external manufacturing and analytical/quality sites is essential.
• Proficiency in chromatographic (HPLC, UPLC, GC), spectroscopic (MS, UV/Vis, FTIR), and other analytical techniques. Experience with method development, validation, transfer, and troubleshooting is essential.
• Experience with late phase development activities (registration/PPQ) is a plus.
• Comprehensive understanding of ICH, FDA, EMA, and other health authority guidelines relevant to analytical method development and validation.
• Excellent written and verbal communication skills, with the ability to present complex scientific data to diverse audiences and write clear, concise technical documents.
• Capacity to manage multiple workflows and priorities in a fast-paced, evolving environment.