Maplight Therapeutics Inc jobs

Lead CRA Remote 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: 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

Associate Director, Medicinal Chemistry Remote 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 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

Executive Director, Clinical Program Management Remote 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. 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 Executive Director, Clinical Program Management provides leadership and direction across the MapLight clinical development portfolio, supporting programs across all stages of development. The role is accountable for oversight, functional leadership, and consistency of program management practices, strengthening the quality and effectiveness of program management across Clinical Development. This role reports to the Senior Vice President, Clinical Development and may have one or more direct reports. Responsibilities - Lead the Clinical Program Management function by defining standards, best practices, and continuous improvement initiatives, and by developing the team through coaching, feedback, and role modeling to strengthen Program Management as a discipline within the organization. - Be accountable for Clinical Program Management effectiveness across the clinical development portfolio. - Align with leadership to deliver corporate and departmental goals and initiatives. - Partner with Clinical Leads and cross-functional teams on program planning, deliverables, and timelines, supporting effective execution across the portfolio.

Clinical Data Manager 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: We are seeking a highly skilled and motivated Clinical Data Manager to join our Clinical Data Management team. Reporting to the Associate Director, the Clinical Data Manager, will play a pivotal role in ensuring the integrity, accuracy, and completeness of clinical trial data, contributing to the successful development and regulatory approval of our products. Responsibilities : - Manage and lead all aspects of clinical trial data management activities from study start-up to database lock. - Develop and implement data management plans, data validation plans, edit check plans and data entry guidelines in compliance with regulatory standards and company SOPs. - Collaborate with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs to ensure data quality and integrity throughout the trial lifecycle. - Oversee Medidata Rave electronic data capture (EDC) system setup, configuration, user management, coding and data extracts. - Perform data cleaning, discrepancy management, SAE and vendor integration reconciliation activities to ensure timely database lock. - Conduct periodic data reviews and generate weekly data quality metrics to identify trends and outliers. - Identify Protocol Deviations - Produce medical monitor, coding listings and ad hoc listings for team review (Jreview, SAS, Business Objects). - Participate in the

Senior Associate, Regulatory Affairs 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. Responsibilities: - Assist Regulatory Lead to support local regulatory activities (e.g., IND/CTA submissions and agency meetings). - Provide and maintain IND/CTA documentation support in collaboration with Regulatory Lead (e.g., draft and prepare forms and cover letters, liaise with and transfer documents for submissions to/from the publishing vendor or CRO). - Create and maintain product regulatory information and history documents (e.g., maintain correspondence logs). - Appropriately archive regulatory documents and agency communications. - Collaborate with CRO's / partners to support clinical study activities. - Complete regulatory forms to support agency communications. - Provide regulatory support through cross-functional interactions in project meetings. - Support the development and execution of project goals. - Monitor the development of new regulatory requirements or guidance documents and support Regulatory Lead to advise product teams of the impact on the business or development programs. - Has flexibility to react rapidly to changing situations/environment. - Willing to travel for occasional in-person team meetings. Qualifications: - A Bachelor's degree in a scientific discipline is required. A relevant advanced degree (e.g., MS, PharmD) is preferred and certification is a plus. - Minimum of 2 years in the pharmaceutical industry. - Strong interpersonal, written, and verbal skills. - Ability

Contracts and Legal Systems Manager 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: 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

Senior Specialist, Clinical Business Operations 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 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

Senior Clinical Trial Associate (Sr. CTA) 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: 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

Director, Safety Scientist, Pharmacovigilance Remote 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 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

Associate Director, Statistical Programming 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: Reporting to the Senior Director, Statistical Programming, the Associate Director will provide statistical and clinical data programming expertise to manage statistical programming activities that support drug development programs and regulatory submissions. This role involves overseeing the creation, validation, and delivery of programming deliverables, ensuring compliance with industry standards, and fostering cross-functional collaboration with biostatistics, data management, clinical, and regulatory teams. Responsibilities: - Oversee the development and validation of SAS programs to generate datasets (SDTM, ADaM), tables, listings, and figures (TLFs) in compliance with CDISC standards. - Ensure the timely and high-quality delivery of programming outputs for regulatory submissions, clinical study reports, and exploratory analyses. - Ensure all programming activities align with industry standards (CDISC, ICH, FDA, EMA) and internal SOPs. - Programming lead for clinical programs as needed. Hand-on programming work in SAS and other programming languages/tools. - Establishes and maintains CRO/vendor partnerships. - Act as a liaison between statistical programming and other functions, ensuring clear communication and alignment of goals. - Partner with biostatistics, data management, and clinical operations to resolve programming issues and optimize processes. - Identify and implement new tools, techniques, and processes to improve efficiency and quality in statistical programming. Qualifications:

Sr. Medical Director, Pharmacovigilance Remote 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 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

Director, Biostatistics 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

Senior Clinical Research Associate (CRA) - Texas or Arizona Texas 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. Location: This is a remote role located in the Texas OR Arizona region. Travel: Position will require up to 75% travel with potential to be higher at times of peak activity. Every effort will be made to keep travel regional but travel outside of a region may be required on occasion. Additional periodic travel for meetings is also expected. What You'll Do: The Sr. CRA will perform quality and compliant Investigator site monitoring and relationship-driven Investigator site management in line with MapLight's SOPs, our Mission, Vision, and Values, as well as industry quality and regulatory best practices (ICH GCP). The CRA will perform on-site monitoring and centralized monitoring to ensure subject safety, the highest data integrity, and contribute to proactive risk management and inspection readiness. This role will collaborate closely with key cross-functional internal stakeholders including Clinical Operations, Medical Monitoring, Data Management, Supply Chain, and Clinical Compliance and Quality as well as external CRO and vendor partners to ensure quality study oversight from study start up through close out. CNS and/or neuropsychiatry, specifically in-patient schizophrenia and/or Alzheimer's disease psychosis or Alzheimer's disease agitation experience strongly preferred. Responsibilities : - Effectively manage assigned Investigator sites

Associate Director, Commercial Strategy and Insights 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: We are seeking a highly motivated Associate Director, Commercial Strategy and Insights to support the development and execution of commercial initiatives across our growing organization. This role will help build market research, forecasting, and competitive intelligence that inform launch planning, market opportunity assessments, and commercial strategy for our lead asset and broader pipeline. As the commercial function grows, the role is expected to evolve into a role on our Insights and Analytics team. The Associate Director will work closely with Commercial Leadership, Marketing, Market Access, Medical Affairs, Sales, Finance, Business Development, and Clinical teams to inform data-driven strategies that maximize product value and support long-term company growth. The ideal candidate combines analytical rigor, strategic thinking, and strong cross-functional collaboration within a fast-paced pre-commercial biotech environment. Responsibilities : - Support market research, forecasting and analytics workstreams that inform integrated commercial strategies for our lead asset and pipeline products. - Conduct market assessments, competitive analyses, and opportunity evaluations to inform strategic decision-making. - Partner with cross-functional teams to define product positioning, target customer segments, and value propositions. - Support commercial launch planning activities for new products and indications. - Identify commercial risks, opportunities, and mitigation

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