What are the responsibilities and job description for the Senior Director, Clinical Operations position at Lifelancer?
Job Title : Senior Director, Clinical Operations
If you think you are the right match for the following opportunity, apply after reading the complete description.
Job Location : United States
Job Location Type : Remote
Job Contract Type : Full-time
Job Seniority Level : Director
Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
Role Summary
The Senior 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
What We Offer
The expected salary range offer for this role is $255,000 to $285,000. 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.
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Salary : $255,000 - $285,000
