Spyre Therapeutics

Director, Clinical Operations

Spyre Therapeutics

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $215,000 - $238,000 per year

Job Level

Lead

About the role

  • 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.

Requirements

  • Bachelor's Degree is required.
  • A minimum of 8 years of global clinical research experience within the pharmaceutical or biotechnology industry.
  • Inflammation and/or Immunology experience is strongly preferred
  • 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.
  • Experience with developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred.
  • 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.
Benefits
  • Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial protocolsstudy planningdata cleaningdatabase lockingstudy report generationregulatory inspectionSOPsINDsNDAsclinical regulatory documents
Soft Skills
communication skillsinterpersonal skillsleadershipteam motivationcollaboration