MapLight Therapeutics, Inc.

Director

• 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.

Director, Biostatistics

Business Operations

• 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.

Senior Specialist, Clinical Business Operations

• 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.

Associate Director, Medicinal Chemistry

Program Manager

• Lead the Clinical Program Management function by defining standards, best practices, and continuous improvement initiatives
• Be accountable for Clinical Program Management effectiveness across the 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
• Ensure quality, consistency, accountability, and responsiveness of the Clinical Program Management function
• Anticipate cross-program risks, conflicts, and resource constraints

Director, Biostatistics

Senior Specialist, Clinical Business Operations

Associate Director, Medicinal Chemistry

Executive Director, Clinical Program Management