Director, Clinical Operations jobs in United States
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Spyre Therapeutics · 22 hours ago

Director, Clinical Operations

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease and rheumatic diseases. The Director, Clinical Operations, is responsible for executing the clinical operational strategy and ensuring that all clinical development activities are conducted efficiently and in compliance with requirements.

BiotechnologyTherapeutics

Responsibilities

Direct input into the clinical operational strategy and plans
Implementation and management of the clinical operational plans and programs to meet corporate goals and objectives
Work with Clinical Development to draft clinical trial protocols and other trial-related documents, and work with other departments and functions to implement clinical trial protocols
Serve as an interface with clinical investigators
Effectively negotiate contracts with consultants, clinical investigators, and contract research organizations
Conduct funding negotiations with clinical sites when necessary
Support the management of site-related activities, development of tracking tools, and manage recruitment timelines
Prepare updates on study progress
Prepare the study budgets, and track payment of contracts related to the project
Generate clinical department SOPs and conduct trainings as necessary
Regularly make presentations to senior staff members and participate in relevant Development Team meetings
Procure and oversee outside vendors and consultants as required
Supervise and manage activities of clinical operations personnel
Ensure familiarity with new developments in disease indications being studied as well as relevant guidelines and regulations pertaining to the conduct of clinical trials
Attend scientific and external training meetings as needed
Other clinical operations activities as required

Qualification

Clinical operations experienceProtocol developmentRegulatory document preparationImmunology experienceStudy planningExecutionCommunicationInterpersonal skillsTeam leadership

Required

Bachelor's Degree is required
A minimum of 8 years of global clinical research experience within the pharmaceutical or biotechnology industry
In-depth understanding and experience across clinical operations with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection
Ability to lead cross functional study teams in a growing and dynamic organization
Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions

Preferred

Inflammation and/or Immunology experience is strongly preferred
Experience with developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred

Benefits

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
Unlimited PTO
Two, one-week company-wide shutdowns each
Commitment to provide professional development opportunities.
Remote working environment with frequent in-person meetings to address complex problems and build relationships.

Company

Spyre Therapeutics

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Spyre Therapeutics is a biotechnology business that is developing a strong pipeline of antibody therapies.

Funding

Current Stage
Public Company
Total Funding
$835M
2025-10-13Post Ipo Equity· $275M
2024-11-18Post Ipo Equity· $200M
2024-03-18Post Ipo Equity· $180M

Leadership Team

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Kate Chevlen
Chief Commercial Officer
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Sheldon Sloan
Chief Medical Officer
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Company data provided by crunchbase