[Remote] Associate Director, CMC Program Management at Axsome Therapeutics Inc

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

BS/MS degree in a scientific or engineering discipline
8 years of biotech experience in process development, manufacturing, and/or analytical development
5 years of CMC program management experience
Proficient in Microsoft Project
Experience in Smartsheet is preferred but not required
High level of attention to detail
Ability to work with ambiguity, and create new, more efficient processes
Ability to communicate effectively with stakeholders across the organization at all levels
Proven ability to manage competing priorities, budgets, and timelines in a fast-paced, rapid-growth environment
Highly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives
Excellent written and verbal communication skills
PMP is a plus

Responsibilities

Develop, maintain, and track project timelines and deliverables for CMC activities, ensuring alignment with organizational and departmental objectives
Coordinate commercial supply readiness and next generation process development activities across CMC, quality, regulatory, commercial, and external CDMO/CMOs
Act as a liaison between CMC team and external partners, consolidate and disseminate key decisions and updates across cross-functional workstreams
Support CMC Subteam and other governance forums to develop, track and execute on CMC functional objectives and lifecycle management initiatives
Work with CMC team to develop, manage and track the CMC budget
Provide CMC project management support, both internally and externally with vendors. This includes activities such as drug substance/drug product development, manufacturing, and supply chain oversight. Proactively track and manage activities at vendors and facilitate resolution of issues to keep project activities on track
Create and maintain program management tools to communicate timelines, deliverables, issues, risks, and mitigations. Ensure cross functional alignment on program status including expectations, opportunities, and risks

Skills

Axsome Therapeutics Inc

Develops therapies for CNS disorders

About Axsome Therapeutics Inc

Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.

New York City, New YorkHeadquarters

2012Year Founded

$430.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Performance Bonus

Company Equity

Risks

Increased competition from companies like Compass Pathways in the CNS market.

Potential delays in AXS-07 launch amid growing market anticipation.

Departure of key personnel like Lori Englebert may impact strategic direction.

Differentiation

Axsome focuses on CNS disorders with limited current treatment options.

AXS-05, an NMDA receptor antagonist, targets major depressive disorder and treatment-resistant depression.

Axsome's balanced portfolio includes both clinical and research stage products.

Upsides

FDA's fast-tracking of CNS treatments could expedite Axsome's drug approvals.

Increased investment in CNS R&D drives innovation, benefiting Axsome's pipeline.

Growing personalized medicine trend offers Axsome opportunities for tailored therapies.

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