Spyre Therapeutics is a clinical-stage 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, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
Role Summary:
We are seeking an experienced Director, Supply Chain, to join our growing Supply Chain team within Technical Operations. You will be responsible for ensuring uninterrupted clinical supply throughout the duration of a clinical study program based upon related targets and regulatory requirements in addition to providing CMO vendor oversight. The role will take leadership for one or more of our global Phase 2 studies and continue to build our supply chain function and processes.
Key Responsibilities:
- Plan and deliver on-time, compliant clinical supply per the clinical development plan
- Serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan
- Lead and manage clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management
- Author, review, and/or approve related clinical and technical documents, including but not limited to: clinical label text, packaging batch records, clinical trial protocol, pharmacy manual, IND, IMPD, and NDA
- Manage existing clinical supply vendors through quoting, execution, changes, and close out, ensuring high performance delivery across all outsourced activities
- Support new vendor identification, selection, and onboarding for future phases and/or capabilities
- Serve as a subject matter expert and develop continuous improvement plans for clinical supply GMP, GDP, and business processes
- Responsible for oversight of scheduling and delivery of clinical supplies including strategies for creating label and packaging design, randomization, packaging, labeling and distribution in compliance with Good Manufacturing Practices (GMP) regulations
- Performs supply forecast modeling (short, medium and long-term) and supports monthly forecasting and production process
- Ensures product requirements and costs for the budget are complete and in place for assigned projects
- Evaluates the impact of changing the inventory targets, clinical demand, and budget restrictions.
- Manages the procurement of comparator drug products and matching placebo as required
- Other duties as assigned
Ideal Candidate:
- Bachelor’s degree or advanced degree in scientific fields with 8+ years of experience in clinical supply chain and logistics
- Strong experience managing clinical supply activities for global phase 3, randomized, I&I and/or IBD clinical trials
- Working knowledge of import and export laws and processes, GMP and GCP requirements related to clinical supply
- Highly organized with the ability to manage many different types of tasks and inputs at once
- Strong analytical and critical thinking skills
- Excellent communication skills and the ability to work effectively in a fast-paced environment
- Proficient in data analysis tools and software
- Detail-oriented with a knack for identifying trends and anomalies
- Experience in a small company or start-up environment is preferred
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 $205,000 to $229,000. 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
What We Do
Spyre Therapeutics combines best-in-class antibody engineering, rational therapeutic combinations, and precision immunology approaches to maximize efficacy, safety, and convenience of treatments for inflammatory bowel disease
