Senior Director, CMC Program Management

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 Manager, CMC Program Management is a key program/project and operational excellence leader for the CMC Program Management group for all early and late-stage development assets. He/she provides project & program management support to the CMC Teams within product development and clinical supply.  He/she is responsible for management and delivery of the integrated program timeline, including incorporating deliverables across functions, SMEs, and indications. This role will help to drive PM best-practices across CMC teams/stakeholders. The CMC Program Manager is specifically responsible for program timelines as it relates to CMC and other critical business partners (RA-CMC, QA, Operations, et al) as well as reporting, risk and budget management, scheduling, facilitating meetings and taking minutes, action items/follow-ups, and other PM-related duties. The candidate must be a strong leader experienced in integrated approaches to CMC development, working with cross functional project teams in a matrix organization, have knowledge of global CMC development strategies, experience with all stages of clinical development and extensive vendor management experience.  

Responsibilities:

• Project Planning and Execution:
  • Develop and maintain comprehensive CMC project plans, including timelines, resource allocation, and risk management.
  • Lead and manage cross-functional CMC teams, ensuring alignment with overall project objectives.
  • Monitor project progress, identify potential roadblocks, and implement mitigation strategies.
  • Manages CMC budget, contracts, and invoices with collaboration of CMC functions and finance
• Communication and Collaboration:
  • Facilitate effective communication and collaboration among internal and external stakeholders, including CMOs, Supply Chain, and other functional areas.
  • Communicate project status, risks, and issues to stakeholders and senior management.
  • Participate in project team meetings, ensuring alignment and addressing CMC-related issues. 
• Quality and Compliance:
  • Together with Quality Assurance, ensure compliance with regulatory requirements and industry standards in all CMC activities.
  • Oversee the development and execution of CMC documentation, including Quality sections of IND/IMPD/NDA submissions.
• Strategic Input:
  • Provide strategic input into the development of CMC strategies and plans.
  • Contribute to continuous improvement activities and the implementation of best practices.
• Risk Management:
  • Together with CMC functions, identify, assess, and manage risks associated with CMC projects.
  • Together with CMC functions, develop and implement risk mitigation and contingency plans.

Qualifications:

• Bachelor's degree in a relevant field (e.g., project management, life sciences).
• Strong understanding of the pharmaceutical and biotech industry and small molecule drug development process.
• 5+ years of experience managing and leading multiple complex projects/programs within the biopharmaceutical industry, preferably as a CMC PM or drug development PM.
• Significant experience with all stages of global CMC development (IND/CTA-NDA/MAA) across multiple products/programs
• Significant knowledge of phase-specific, global CMC practices and regulatory requirements
• Strong knowledge of ICH Guidelines, 21 CFR 210/211, and GMP processes
• Must be able to create a highly collaborative and inclusive environment necessary for the cross-functional CMC teams to be effective.
• Strong track recordin executing effective program management skills in cross-functional matrix organizations. 
• Excellent knowledge of program and project management discipline and its application to drug development to deliver time, cost, quality, and risk management to teams.
• Demonstrated success in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and risk management.
• Demonstrated ability to effectively implement the tools and techniques of the program and project management discipline, such as the development and management of multi-disciplinary program level integrated plans, critical path management, proj