Director, Non-Clinical Program Management
2 weeks ago
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 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.
Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
Salary Range
$200,000—$230,000 USD
EEOC Statement: 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.
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