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, project risk management, decision analysis and meeting management.
• Proven track record of achievement and delivery of team goals.

Location: This is a hybrid role with three days per week onsite in either our Burlington, MA or Redwood City, CA offices. Please refer to the city listed on the top of this post for this role's location. 

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.