[Remote] Director, Medical Information at Axsome Therapeutics Inc

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Scientific and business expertise relevant to therapeutic areas
Demonstrated proficiency in medical writing
Ability to understand, interpret, and accurately communicate scientific data and statistical analyses
Scientific expertise consistent with the regulatory/compliance landscape
Experience with literature searches
Ability to leverage technology and innovation to optimize the delivery of medical information
Experience analyzing and reporting trends in scientific insights
Experience delivering accurate, focused, and scientifically balanced clinical and scientific information exchange with Health Care Providers
Experience serving as a Medical information reviewer for medical and commercial review committees
Experience working cross functionally with the broader organization

Responsibilities

Planning, prioritization, and execution of Medical Information deliverables
Working cross functionally with key partners (Medical Affairs, compliance/legal, clinical development, pharmacovigilance, commercial, and regulatory)
Ensuring the Medical Information team (inclusive of the call center) is poised to execute comprehensive, strategic plans across the franchise
Development, review, and maintenance of scientific medical information content and escalated inquiries
Proactively leading, coordinating with, or providing oversight of the call center/contractors and/or responding to medical information inquiries (including escalations)
Conducting advance literature searches
Analyzing, identifying, and reporting trends in scientific insights
Delivering accurate, focused, and scientifically balanced clinical and scientific information exchange with Health Care Providers
Working cross functionally to develop/update medical information content (SRLs, FAQs, Guidelines & Compendia submissions, dossier, etc.)
Assisting with managing the call center and contractors (training, overseeing fulfillment of unsolicited inquiries, development of responses, QA)

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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