Manager/Sr. Manager, Clinical Trial Supply
60 First St, Cambridge, MA 02141
R & D – Clinical /
Full-time /
Hybrid
Company Summary: Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro’s lead program is Alpha-1 Antitrypsin Deficiency (AATD). Korro is based in Cambridge, Massachusetts.
We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.
Position Summary:
The Manager/Sr. Manager, Clinical Trial Supply will work as a member of Korro Clinical Operations team, assisting in the development of new products and product line extensions by managing investigational products in support of the clinical development pipeline and other clinical studies. The core responsibilities include on-time delivery of study drug to study participants and management of the clinical supply chain (packaging, labeling, distribution, inventory management, returns, and destruction of IMP/CTM). Key interactions are with Technical Operations, Clinical Development, Quality, Regulatory, and with external vendors (packaging, IRT/IXRS). This position reports to the VP Clinical Operations.
Excellent written and oral communication skills are required, as is the desire and ability to work in a small, fast-paced, and patient-focused environment.
Key Responsibilities:
- Develop clinical forecast / demand plans based on trial requirements. Routinely identify risks in supply chain, recommend mitigation plans to management, and implement solutions.
- Ensure on time delivery of clinical supply to depots and sites in accordance with each clinical protocol and plan.
- Work with cross-functional team to define clinical supply plan for each study; participate in relevant team meetings providing clinical supply status reports and support.
- Review clinical protocols for study supply requirements.
- In collaboration with quality, create label text in compliance with regulations, and manage translations and country-specific requirements.
- Contribute to the design of study drug packaging in accordance with needs of the study.
- Manage vendors to perform the labeling, packaging, and global distribution of investigational product and ancillary supplies.
- Develop of IRT (IXRS) supply and return strategy, lead the IRXS set up, and participate in User Acceptance Testing where needed.
- Manage Evaluation of Temperature Excursions.
- Develop requirements/specifications for clinical study drug and other drug supply as required (GLP, non-GLP non-clinical), including packaged product specifications, product shipping and storage specifications.
- Contribute to study specific pharmacy. manuals and supply related training/instructional materials (e.g. IM and SIV slides, dosing cards, accountability forms)
- Coordinate with Supply Chain for use of commercial products in a clinical environment.
- Stay current on all Korro Bio SOP’s related to CTM/IMP distribution and follow procedures for release of IMP to clinical site(s).
- Develop clinical supply budget and forecasting; track invoices to contracts.
- Provide to Regulatory Affairs any applicable information or sections of IND/IMPD/CTA/etc. submissions.
Qualifications:
- Bachelor’s Degree and a minimum of five years professional experience, or equivalent experience, in pharmaceutical/biotech industry.
- Experience in clinical trial supply sourcing and management required.
- Supply chain/distribution logistics/import export/customs experience required.
- Experience with cold chain distribution and ultra-cold products.
- Knowledge of regulatory requirements for IMP.
- Experience setting up and managing shipments and inventory in IXRS/IRT systems.
- External vendor management experience required.
- Excellent written and oral communication skills.
- Ability to work independently with minimal oversight.
- Strong interpersonal skills and ability to function in a dynamic team environment.
- Strong computer skills, with proficiency in spreadsheet, presentation and word processing software.
- Flexibility to travel on company business as required.
Benefits: Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.
