Vice President, Project Management

Alzheon, Inc.; Framingham, Northern (MA, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Alzheon, Inc. seeks a seasoned VP, Project Management to unify regulatory, clinical development, CMC, nonclinical, biometrics, medical, and commercial workstreams into one clear plan.

You will drive the integrated program, test assumptions, and provide leadership with a current view of what it takes to advance ALZ-801. You will partner with functional leaders to set critical paths, resolve cross‑functional tradeoffs, and ensure decisions translate into action, especially during late-stage

Qualifications

• 12+ years in biopharmaceutical project/program management with cross-functional leadership.
• Experience running late-stage development programs across multiple functions.
• Understanding of end-to-end drug development from early to NDA readiness.
• Proven ability to communicate with senior leaders and regulatory authorities.

Responsibilities

• Own the integrated ALZ-801 project plan across regulatory, clinical, CMC, nonclinical, biometrics, medical, commercial.
• Build and maintain critical path, milestones, dependencies, resources, and contingency plans.
• Lead cross-functional meetings to drive decisions and accountability.
• Coordinate strategy with Regulatory for meetings, information requests, NDA readiness.
• Align trial execution, data readiness, milestones, and clinical reporting with teams.
• Ensure development, manufacturing, comparability, supply, and inspections align to the plan.
• Present integrated timing, risk, and cost views to executives and Board.
• Manage risk, issues, and changes; escalate when needed to protect the program.
• Leverage AI tools to improve planning quality and scenario testing.
• Establish governance, cadence, action tracking, and documentation for speed and accountability.
• Oversee external partners and CROs, ensuring alignment with the ALZ-801 program.

Skills

Program leadership

Cross-functional collaboration

Executive communication

Risk management

Strategic planning

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

AI-enabled planning

Risk management tools

Project management software

Job description

Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of devastating neurodegenerative disorders. Our lead Alzheimer’s clinical candidate, ALZ-801 , is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that fully blocks formation of neurotoxic soluble amyloid oligomers in the brain. Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients.

Our experienced and passionate drug development team is focused on applying precision medicine, cutting-edge disease biomarkers, brain imaging and unique biologic insights to advance therapies with the greatest impact for patients. We are seeking individuals with an entrepreneurial spirit to join our team and help make the first oral Alzheimer’s disease-modifying therapy a reality for patients and their families, in a few short years.

Position Overview

Alzheon is seeking a seasoned program leader to serve as Vice President, Project Management, bringing the regulatory, clinical development, CMC, nonclinical, biometrics, medical, and commercial workstreams together around one clear plan. You will run the integrated program, make dependencies visible before they become problems, and give the leadership team an honest, current view of what it will take to move ALZ-801 forward.

You will work directly with functional leaders to set the critical path, pressure-test assumptions, resolve cross-functional tradeoffs, and make sure decisions turn into action. The role is especially important as the program moves through late-stage development, and regulatory interactions.

You will also help modernize how the program is run. That means using AI-enabled planning, scenario analysis, risk sensing, and workflow automation where they make the team faster and more reliable, while keeping functional leaders accountable for the scientific, clinical, quality, and regulatory decisions.

Key Responsibilities

• Own the integrated ALZ-801 project plan across regulatory, clinical development, clinical operations, CMC, nonclinical, biometrics, medical, commercial, quality, and supporting functions.
• Build and maintain the critical path, key milestones, decision points, dependencies, resourcing assumptions, and contingency plans for the program.
• Lead cross-functional project team meetings and working sessions that drive decisions, resolve issues, and hold owners accountable for follow-through.
• Partner with Regulatory to coordinate strategy, agency meeting preparation, information requests, submission readiness, and the work needed to support a potential NDA.
• Partner with Clinical Development, Clinical Operations, Biometrics, and Data Management to align trial execution, data readiness, analysis milestones, and clinical reporting.
• Partner with CMC, Quality, and Clinical Operations to align development, manufacturing, comparability, supply, and inspection-readiness activities with the overall program plan.
• Turn functional plans into a single integrated view of timing, risk, cost, and decision readiness for executive leadership and the Board.
• Run disciplined risk, issue, and change management, escalating early when a decision, resource, or tradeoff is needed to protect the program.
• Use AI-enabled program tools and automation to improve planning quality, surface risks and dependencies, reduce manual coordination, and help teams test realistic scenarios.
• Establish clear governance, including decision rights, meeting cadences, action tracking, and documentation that lets the program move quickly without losing accountability.
• Manage external partners, consultants, and CROs as needed, ensuring their plans and deliverables are fully connected to the ALZ-801 program plan.
• Build the project management capability around ALZ-801, including practical methods, tools, and team support that scale with the program.

Requirements

• Bachelor’s degree in life sciences, pharmacy, engineering, business, or a related field; an advanced degree is preferred.
• 12+ years of progressive biopharmaceutical project or program management experience, including leadership of complex, cross-functional development programs.
• Demonstrated experience running a late-stage clinical development program across multiple functions, with accountability for integrated planning, risks, and executive communication.
• Working knowledge of drug development from early development through registration, including clinical, regulatory, CMC, nonclinical, biometrics, quality, and commercial planning.
• Experience preparing for or supporting major health-authority interactions, regulatory submissions, and/or NDA readiness.
• Sound judgment in surfacing difficult tradeoffs, framing decisions, and bringing senior leaders to resolution when functional priorities conflict.
• Excellent written and verbal communication, with the ability to make complex program information clear, direct, and useful to both technical teams and executives.
• A hands-on leadership style, with the ability to move comfortably between executive discussions and the working-level details that determine whether a plan holds up.

Preferred Qualifications

• Experience in Alzheimer’s disease, neurodegeneration, or another CNS therapeutic area.
• Experience leading programs through Phase 3, NDA preparation, and/or commercial launch planning.
• Experience working in a small or mid-sized biotechnology company where program leaders need to be strategic and operationally involved.
• Experience applying AI, advanced analytics, or workflow automation to improve program planning, risk management, or operating cadence.
• PMP certification or comparable formal training in project and program management.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.