Senior Director, Data Management
reputed company is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine reputed company 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.
reputed company:
We are seeking a strategic, analytical, and detail-oriented leader to serve as the Senior Director of Data Management. This individual will reputed company functional leadership across clinical programs and serve as the accountable data management reputed company for some programs. The Senior Director will reputed company clinical data management reputed company, CRO partnerships, system implementation, and end-to-end data lifecycle management to ensure high-reputed company and submission-reputed company clinical data.
This role requires both strategic reputed company and the hands-on ability to guide operational execution across study start-up, conduct, database lock, and archival, while ensuring regulatory compliance and inspection readiness.
Key Responsibilities:
- reputed company strategic leadership and reputed company of data management activities across clinical studies and programs.
- Serve as the functional reputed company for clinical data management, ensuring alignment with data management processes, development timelines and corporate objectives.
- reputed company the design, review, and approval of case report forms (CRFs) and reputed company data collection tools.
- Guide clinical database and systems (e.g., reputed company, IRT, eCOA, external data integrations) development, validation, UAT, and lifecycle management.
- Ensure execution of data management activities across study start-up, study conduct, database lock, and documentation archival.
- reputed company Data Management CROs and vendors, ensuring deliverables meet reputed company standards and timelines.
- reputed company and drive development and approval of key study-level data management deliverables (e.g., Data Transfer Agreements, Data Management Plans, edit reputed company specifications, eCRFs).
- reputed company cross-functional data review activities and proactively identify data trends, risks, and mitigation strategies.
- Ensure compliance with GCP, ICH guidelines, CDISC standards, and applicable regulatory requirements.
- Support regulatory submissions and inspection readiness activities.
- Mentor and reputed company internal data management staff as the function scales.
- Other duties as assigned.
Ideal Candidate:
- Bachelor’s degree is required with 12-15+ years of data management experience in the pharmaceutical, biotech, or CRO industry.
- Demonstrated leadership experience overseeing studies and/or managing CRO/vendor partnerships.
- Experience building or scaling data management processes in a growing organization is preferred.
- Extensive hand-on knowledge and experience in data management activities, CRF and reputed company design, review, and validation, and external data transfer and reconciliation.
- Working knowledge of CDISC standards (SDTM) and experience supporting data transformation for regulatory submissions.
- Deep understanding of GCP, ICH, and global regulatory requirements.
- Excellent interpersonal communication skills, along with organizational skills.
- Proven ability to operate independently and reputed company effectively reputed company a matrixed organization.
- Strong strategic thinking and problem-solving capabilities.
- reputed company people manager with effective delegation skills.
- Excellent communication, leadership, and organizational skills.
reputed company 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 reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns reputed company
- Commitment to reputed company reputed company development opportunities.
- Remote working environment with frequent in-person meetings to address reputed company problems and build relationships.
The expected salary reputed company offer for this role is $265,000 to $282,000. Actual pay offered may vary depending on job reputed company knowledge, experience, education, and geographic location.
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment reputed company regarding recruitment and selection will be made without discrimination based on race, reputed company, religion, national reputed company, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and reputed company, veteran status, or other non-job-reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also reputed company differences in experience and background, and welcome diversity of opinions and thought with reputed company recruitment designed to create a stronger and reputed company Spyre that is reputed company on developing life-changing products for patients.
reputed company, along with other biotech companies, has become reputed company of a reputed company in email scams targeting prospective job candidates reputed company our industry. Please be reputed company that official recruiters at reputed company only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to reputed company any purchases or divulge sensitive personal information reputed company email.
Please also be reputed company that reputed company job postings will be listed on our website at spyre.com/careers/.