Director, Non-Clinical Program Management

MapLight Therapeutics•Burlington, MA

49d•Hybrid

About The Position

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. The Non-Clinical Program Manager will oversee and coordinate preclinical activities supporting the development of novel therapeutics in neurology and psychiatry. This individual will manage timelines, deliverables, and cross-functional communication among discovery biology, pharmacology, toxicology, and external CRO partners. This person will play a key role in ensuring smooth execution of IND-enabling studies and alignment with overall program goals. The Program Manager will have significant experience in organizing and leading cross-functional teams and programs through early research, drug candidate selection, IND-enabling studies, pre-IND activities and IND submissions.

Requirements

Bachelor’s or advanced degree in life sciences (neuroscience, pharmacology, toxicology, or related discipline).
10+ years of experience in biotech/pharmaceutical industry, including at least 3 years in non-clinical or preclinical project management.
Familiarity with drug discovery and IND-enabling workflows.
Experience working with CROs and managing outsourced studies preferred.
Understanding of regulatory expectations for non-clinical development (FDA, EMA, ICH).
Strong organizational, analytical, and problem-solving abilities.
Excellent written and verbal communication skills.
Proficiency in project management tools (e.g., Smartsheet, MS Project, or equivalent).
Ability to thrive in a fast-paced, cross-functional biotech environment.

Nice To Haves

Background in neurology, neuroscience, or CNS drug development preferred.
PMP or equivalent project management certification a plus.

Responsibilities

Manage Program team meetings, including leading discussions to drive to effective decision-making, agenda creation, and meeting minutes
Establish project milestones, manage work plans, and ensure resources are aligned to meet project objectives
Identify and track critical path/activities, risks, contingencies, and alternatives.
Collaborate with and support all stakeholders to ensure integration of project and functional goals
Develop program budgets and oversee program budget forecasting and reporting
Identify and mitigate project risks, ensuring proactive communication and resolution of issues.
Coordinate cross-functional input from discovery, pharmacology, toxicology, DMPK, and CMC teams.
Support design, initiation, and monitoring of non-clinical studies, including pharmacology and toxicology.
Facilitate interactions between internal scientific teams and external CROs, ensuring clear communication of objectives and deliverables.
Manage documentation, data flow, and reporting for regulatory submissions (e.g., IND, CTA).
Lead regular project team meetings, prepare agendas, capture minutes, and follow up on action items.
Summarize project status and key milestones for senior management and program governance reviews.
Maintain alignment between scientific teams and program management on priorities and timelines.
Contribute to development and optimization of processes and tools to improve efficiency in non-clinical project execution.