Director, Non-Clinical Program Management

What You’ll Do: 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.

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.

Qualifications:

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

Location: This is a hybrid position onsite at our office in Burlington, MA three days per week.