Director, Clinical Operations

Spyre Infostructure Inc.; United States; Remote; USD 210,000 - 228,000; Full time

Job summary

Spyre Infostructure Inc. is seeking a Director, Clinical Operations to oversee and implement clinical trial strategies ensuring compliance and efficiency. The ideal candidate will have extensive experience in clinical research and proven leadership skills, offering a competitive salary, remote working options, and professional development opportunities. You will play a crucial role in advancing innovative therapies for immune-mediated diseases.

Benefits

Unlimited PTO

Market competitive compensation and benefits package

Commitment to professional development

Opportunity to work in a fast-paced environment

Frequent in-person meetings

Qualifications

• A minimum of 8 years of global clinical research experience.
• Experience with clinical operations, study planning, and regulatory inspections.
• Experience developing clinical protocols and regulatory documents.

Responsibilities

• Direct input into the clinical operational strategy.
• Implementation and management of clinical operational plans to meet corporate goals.
• Serve as an interface with clinical investigators and negotiate contracts.

Skills

Communication

Leadership

Interpersonal Skills

Negotiation

Education

Bachelor’s Degree

Job description

Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23.

Role Summary:

The Director, Clinical Operations is a pivotal role responsible for executing the clinical operational strategy to ensure that all clinical development activities within the company are conducted efficiently to agreed corporate timelines and in compliance with local and global requirements. You will support the clinical team with the implementation and oversight of clinical trials, focusing on the areas of clinical operational strategy, trial logistics planning, enrollment, site monitoring, data quality, and study reporting. This role will be the critical interface between Sponsor, CRO, and team at study sites.

Key Responsibilities:

• Direct input into the clinical operational strategy and plans.
• Implementation and management of the clinical operational plans and programs in order 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.

Ideal Candidate:

• 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.

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 $210,000 to $228,000. 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/.

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