Axsome Therapeutics Inc

Contract, Clinical Operations

Oregon, United States

Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
BiopharmaceuticalIndustries

Job Description: Contract, Clinical Operations

Employment Type: Full time

Company Information

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years, our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture! Site: www.ptcbio.com

Position Overview

The Contract, Clinical Operations provides the scientific and operational expertise required to lead the execution of the complete life cycle of clinical trials in accordance with appropriate regulatory requirements for one or more indications within or across therapeutic areas. The incumbent works as an integrated member of the clinical team to manage clinical trial(s) from study design through close out. The incumbent works cross-functionally with internal departments and external resources on Clinical Operations related issues. The Contract, Clinical Operations supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Responsibilities

Essential Functions:

  • Performs as an integrated member of the clinical team to lead, direct, and contribute to the planning, execution, and reporting of clinical trials.
  • Includes estimation of clinical project timelines, protocol writing, Case Report Form (CRF) design, site selection, study drug forecasting, site and Clinical Research Organization (CRO) management, data review, and study reporting.
  • Recommends monitoring, safety, eligibility, enrollment, and data consistency strategies.
  • Interacts with external and internal project team members to assist in the development of clinical strategies, trial design, study plans, and project deliverables.
  • Meets with investigators and PTC scientific and clinical staff to obtain direction and feedback.
  • Assists in the evaluation of scientific literature and investigator advice regarding current clinical practice as a component of clinical strategy and protocol development.
  • Writes, reviews, and/or edits study protocols, protocol amendments, study manuals, informed consent forms, and related documents.
  • Prepares investigational site lists and participates in the review and approval of investigational sites.
  • Negotiates contracts and budgets with sites and vendors and presents to the project team for approval.
  • Plans, coordinates, and conducts investigator meetings including presentations at the meetings.
  • Responds to questions from sites and trial monitors regarding trial conduct.
  • Manages clinical study timelines using the appropriate project management tools.
  • Develops budgets and manages expenditures for clinical trial program, including those for investigational sites and vendors.
  • Presents project progress reports through accurate, succinct summaries of clinical study work at internal team meetings and investigator meetings.
  • Facilitates regulatory submissions and communications by working with appropriate team members during the submission process.
  • Writes assigned portions of reports for submission to regulatory agencies, institutional review boards, scientific journals, and conferences.
  • Provides on-going review of clinical trial data to ensure timely, consistent, and accurate data.
  • Assists in the interpretation of clinical data in preparation for clinical study reports and regulatory submissions.
  • Compiles and reviews assigned portions of reports for submission to regulatory agencies and Institutional Review Boards (IRBs) and Ethics Committees (ECs).
  • Addresses and resolves questions from sites and trial monitors regarding trial conduct.
  • Performs other tasks and assignments as needed and specified by management.

Requirements

  • Minimum level of education and years of relevant work experience.

Application Instructions

(No specific application instructions were provided in the original text.)


Note: Salary and Location Type information were not provided in the original job description.

Skills

Clinical Trial Execution
Protocol Writing
CRF Design
Site Selection
Study Drug Forecasting
Site Management
CRO Management
Data Review
Study Reporting
Regulatory Requirements
SOP Adherence
Clinical Strategy Development
Clinical Trial Design
Study Planning

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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