Associate Director, Clinical Operations

United States

Apply with AI Apply

Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

BiopharmaceuticalIndustries

Requirements

Candidates should possess a Bachelor’s degree in a scientific discipline and a minimum of 7 years of progressively responsible experience in clinical research, with a focus on US and/or global clinical operations. Strong experience in managing clinical trials from study design through close out is required, along with familiarity with regulatory requirements and SOPs.

Responsibilities

The Contract, Associate Director, Clinical Operations will lead and direct the planning, execution, and reporting of clinical trials, including protocol development, site management, data review, and study reporting. They will collaborate with internal and external teams to develop clinical strategies, manage timelines and budgets, and prepare regulatory submissions. Additionally, the role involves interacting with investigators, conducting investigator meetings, and providing ongoing review of clinical trial data, while also managing direct reports.

Skills

Clinical Trial Management

Protocol Writing

CRF Design

Site Selection

CRO Management

Data Review

Regulatory Compliance

Project Planning

Team Leadership

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.

Land your dream remote job 3x faster with AI

Try Jobo Free