Position Overview
The Senior Director, Clinical Supplies Management will provide program-specific leadership and subject matter expertise in clinical trial material supply management in support of a best-in-class portfolio of clinical programs. This leader will develop clinical trial material supply chain strategy and oversee the planning and execution of outsourced clinical trial material supply chain activities. The incumbent will collaborate with internal stakeholders and work proactively with external suppliers including CDMOs/CROs and contract labs to define project scope, mitigate risks, and ensure successful delivery regarding technical quality, timelines and budget. The position requires strategic vision and hands-on experience managing early-stage biotech programs in a dynamic, fast-paced environment.
Responsibilities
- Establish clinical trial material supply chain strategy for a best-in-class portfolio of clinical programs. Develop and implement clinical trial material inventory management system.
- Define and own all drug-supply logic within the IRT/RTSM system, including kit definitions, pack sizes, resupply algorithms, site-level buffer stock and trigger levels, dispensing visit schedules, and expiry handling.
- Partner with Clinical Operations and the CRO/RTSM vendor to translate protocol and supply requirements into IRT specifications, ensuring the system reflects actual supply strategy.
- Integrate the clinical trial material supply plan with CMC to create a supply chain logistics, distribution plans and manage drug product inventory to support clinical trial initiation and on-going clinical trials.
- Maintain continuous reconciliation between IRT inventory and physical stock across depots and sites, ensuring quarantine, release, and excursion status are accurately reflected so unusable material is never assigned to a subject.
- Oversee operations related to drug product labeling and packaging. In partnership with QA, support deviation investigation and associated CAPAs for finished drug product release for clinical use.
- Manage distribution, return, and destruction activities, track finished drug product inventories and expiry dates, and coordinate import/export requirements.
- Own supply-side User Acceptance Testing (UAT), including development and execution of test scripts validating resupply triggers, dose-escalation handling, and correct exclusion of expired or quarantined material, keeping IRT readiness off the study critical path.
- Manage temperature-excursion evaluation and disposition for temperature-sensitive drug product, ensuring cold-chain integrity from depot through site dispensing
- Lead CDMO/CRO selection, contract negotiation, and budget/scope management related to clinical trial material supply chain.
- Manage the Qualified Person (QP) release and import interface for ex-US regions as programs expand globally
- Support regulatory inspections and audits, and provide supply chain documentation for regulatory submissions (e.g., IMPD/IND supply sections)
- Own GMP/GDP compliance across supply chain activities, including execution and maintenance of Quality Agreements with supply vendors
- Maintains an understanding of current trends and emerging technologies in clinical material supply chain management.
- Provides clear communication to management regarding progress against technical objectives/milestones.
- Ensures well-organized, clear and complete records of all activities across areas of responsibility
Education & Experience
- BS/BA in science or engineering or a related field with a minimum of 15 years hands-on working experience in clinical trial material supply management in the biopharmaceutical industry is required. Advanced degree preferred.
- Must have hands-on working experience in global IRT systems and global labelling requirements as well as import/export licensing and placebo-controlled trials.
- Must have extensive hands-on working experience with global CDMOs/CROs in clinical trial material supply management
- Demonstrated experience with relevant systems/softwares to track and manage clinical trial material supply and inventory
Skills & Attributes
- Familiar with current regulatory requirements related to biologics manufacturing and clinical trial material supply.
- Hands-on working experience of global regulatory submissions.
- Must work well in a small team setting, with ability to work independently and collaboratively.
- Proven track record of global CDMO/CRO management
- Ability to work flexible business hours to communicate with global business partners
- Strategic thinker with a hands-on approach; comfortable balancing long-term planning with day-to-day execution
- Exceptional communication and relationship-building skills, with the ability to influence across levels and functions
- Strong attention to detail and problem-solving skills
- Ability to distinguish between critical and non-critical priorities
Korsana Biosciences is the sixth groundbreaking company launched by Paragon Therapeutics, a premier biotech incubator founded by Fairmount Funds in 2021, known for its expertise in discovering and developing cutting-edge therapeutic assets in-house.
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Korsana Biosciences is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.