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 (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
Role Summary:
We are seeking an analytical and detail-oriented individual, who will serve as the lead clinical data manager for clinical studies as assigned and is responsible for providing input to protocols, leading design and review of case report forms, assisting with development and validation of clinical databases and systems, and performing all data management related activities.
Key Responsibilities:
- Perform data management study activities and manage timelines during study start-up, study conduct, database lock, and documentation archival
- Conduct oversight of and provide guidance to data management CROs to ensure that data management documents and tasks are completed and delivered in accordance with timelines and data quality standards
- Oversee and drive development of study related data management deliverables (e.g., eCRF, DTA, etc.)
- Participate in the implementation and UAT of clinical systems (e.g., EDC, IRT, eCOA)
- Coordinate cross functional data review and provide proactive review of data trends and issue resolution
- Other duties as assigned
Ideal Candidate:
- Bachelor’s degree is required. 10+ years of data management experience in the pharmaceutical, biotech, or CRO industry, with 5-8 years as a Lead Data Manager.
- Hands-on knowledge and experience in data management activities, such as CRF and EDC design, review, and validation of data from various vendors
- Knowledge of real-time data flow across clinical systems
- Strong knowledge of EDC systems (Medidata Rave, Veeva, or equivalent)
- Knowledge of GCP, ICH, and regulatory requirements
- Successful track record of working independently in a matrixed organization or in a start-up environment and providing effective solutions to emerging problems
- Excellent interpersonal communication skills, along with organizational skills
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 $170,000 to $186,000. 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/.
Top Skills
Spyre Therapeutics San Francisco, California, USA Office
San Francisco, California, United States
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