[Remote] Senior Director, Clinical Development at Axsome Therapeutics Inc

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

M.D. (U.S. board-certified) with subspecialty training or experience in Nephrology or Rheumatology/Immunology strongly preferred
4+ years of clinical development experience in the pharmaceutical, biotech, or academic research setting
In-depth knowledge of clinical trial design, data analysis, and interpretation in late-stage development
Strong written and verbal communication skills

Responsibilities

Serve as Clinical Lead for one or more clinical programs from early- through late-stage development, contributing to strategic planning, protocol design, and execution
Analyze and interpret clinical trial data, ensuring appropriate actions are taken to advance development programs and inform corporate decision-making
Lead or support the development of key regulatory documents (e.g., INDs, NDAs, CTAs), study reports, and publications; represent the clinical program in health authority interactions
Provide oversight and medical accountability for multiple trials across early development clinical lifecycle
Assess safety-related adverse events in partnership with Global Safety and oversee contributions to safety narratives
Deliver strong presentations for internal and external communications (Investigator meetings, DMCs, Steering Committee)
Act as a key medical and scientific leader, representing the medical and scientific integrity of the company
Lead science-driven product development and inform clinically related corporate decisions
Ensure clinical programs meet required quality and safety standards
Perform medical review of clinical documents submitted to regulatory agencies
Participate in meetings with regulatory agencies as clinical program leader
Lead publication strategy in close collaboration with relevant internal functions
Lead interactions and build relationships with medical and scientific advisors, maintaining relationships consistent with development and commercial objectives

Skills

Key technologies and capabilities for this role

Clinical DevelopmentDrug DevelopmentClinical ResearchNephrologyRheumatologyImmunology

Questions & Answers

Common questions about this position

What qualifications are required for the Senior Director, Clinical Development role?

Candidates must be a US board-certified physician with subspecialty training or prior drug development experience in Nephrology or Rheumatology/Immunology, and at least four years of clinical research and development experience.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What does the company culture emphasize?

The company culture is built on core values that inspire daily work, guide hiring, advancing the mission together, and improving medical treatment for patients with immunological diseases; they seek high-integrity, values-driven colleagues.

What makes a strong candidate for this Senior Director role?

A strong candidate is a highly skilled, team-oriented, US board-certified physician with subspecialty training or experience in Nephrology or Rheumatology/Immunology, at least four years in clinical R&D, high integrity, values-driven, and focused on innovative drug development to improve patient care.

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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