{bc}
Apply
greenhouse

Executive Director, Clinical Operations

Spyre Therapeutics
Remote, USA
Director · 10+ years experience
Remote
Discovered 2 days ago

Full Job Posting

Key Responsibilities:

  • Lead the development and execution of clinical operational strategies and study plans aligned with clinical development priorities and corporate objectives. Oversee global clinical trial activities from feasibility and start-up through enrollment, trial conduct, database lock, and closeout.
  • Establish and manage trial timelines, budgets, resource plans, and performance metrics; identify risks early, establish mitigation plans, and drive timely resolution of issues.
  • Partner with Clinical Development and cross-functional colleagues to assess protocol feasibility and contribute operational input to protocols, informed consent forms, study plans, and other trial-related documents.
  • Implementation and management of the clinical operational plans and programs in order to meet corporate goals and objectives.
  • Lead CRO and vendor selection, contracting, governance, and performance oversight, ensuring clear responsibilities, effective communication, and accountability for deliverables.
  • Oversee country and site feasibility, site selection, activation, monitoring, and closeout activities.
  • Build effective relationships with clinical investigators and site teams to support trial execution, participant recruitment and retention, and timely issue resolution.
  • Develop and oversee enrollment strategies along with Medical Affairs, monitor recruitment performance, and implement actions to address enrollment challenges.
  • Partner with Data Management, Biometrics, Clinical Development, and other functions to support data quality, timely query resolution, database lock, and clinical trial reporting.
  • Develop and manage study budgets, oversee contract and budget negotiations, and monitor forecasts, invoices, and payments in partnership with Finance and Legal.
  • Partner with Quality to maintain inspection readiness, support audits and regulatory inspections, and ensure timely resolution of findings and implementation of corrective actions.
  • Develop and maintain Clinical Operations SOPs, processes, and tools; provide training and drive improvements that support quality and efficient execution.
  • Provide clear, actionable updates to senior leadership and Development Teams on study progress, budget performance, risks, and decisions requiring escalation.
  • Lead, mentor, and develop Clinical Operations personnel, establishing clear expectations and fostering collaboration, ownership, and high-quality execution.
  • Maintain current knowledge of relevant therapeutic areas, clinical trial practices, and applicable regulatory requirements.
  • Regularly make presentations to senior staff members and participate in relevant Development Team meetings.
  • 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.
  • Ideal Candidate:
  • Bachelor’s degree in a scientific, healthcare, or related discipline required; advanced degree preferred. A minimum of 10 years of global clinical research experience within the pharmaceutical or biotechnology industry.
  • Late-stage dermatology clinical trial experience is strongly preferred.
  • Demonstrated success overseeing clinical trial planning, start-up, enrollment, monitoring, data cleaning, database lock, closeout, and clinical trial reporting.
  • Experience leading CROs and other clinical service providers, including vendor selection, contract negotiation, governance, and performance management.
  • Strong financial and operational management skills, including study budgeting, forecasting, resource planning, and risk management.
  • Thorough understanding of Good Clinical Practice and applicable local and global clinical trial requirements, with experience supporting audits, regulatory inspections, and inspection readiness.
  • Experience contributing to protocols, SOPs, clinical study reports, and regulatory submissions preferred.
  • Demonstrated ability to lead and develop Clinical Operations personnel and guide cross-functional teams through influence.
  • Excellent communication, interpersonal, and decision-making skills, including the ability to communicate complex issues and recommendations clearly to senior leadership.
  • Ability to manage competing priorities, adapt to changing needs, and combine strategic thinking with hands-on execution in a growing organization.

What We Offer:

  • 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.
  • The expected salary range offer for this role is $285,000 to $310,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
  • As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.
  • Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.
  • Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Preferred Qualifications

  • Bachelor’s degree in a scientific, healthcare, or related discipline required; advanced degree preferred. A minimum of 10 years of global clinical research experience within the pharmaceutical or biotechnology industry.

Apply for this job in 1 click

Skip the repetitive application forms

Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.

Sarah M.James T.Maya R.

Trusted by over 500,000 job seekers on Base Career

Start Free Today

More from this employer

More jobs at Spyre Therapeutics

Senior Director, Biostatistics

, USA

Discovered 2 weeks agoFull-time

Senior Scientist, Translational Science

, USA

Discovered 3 weeks ago

Senior Director, Drug Safety and Pharmacovigilance Operations

, USA

Discovered 3 weeks agoFull-time

Associate Director, Clinical Supply Chain

, USA

Discovered 3 weeks agoFull-time

Director, Drug Safety Physician

, USA

Discovered 3 weeks agoFull-time

Senior Director, Biostatistics

, USA

Discovered 1 months agoFull-time

Senior Medical Director, Clinical Development

, USA

Discovered 1 months agoFull-time

Vice President, Clinical Development

, USA

Discovered 1 months agoFull-time