Senior Manager, Clinical Drug Supply

Job Description

Job Description

Description :

Why join Cardurion Pharma?

At Cardurion, we are advancing the understanding of the cellular mechanisms that regulate heart function and are developing new treatments to address cardiovascular disease. Our programs seek to modulate signaling pathways that regulate heart cell function to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our site to learn more about our Company and how we are advancing the promise of cardiovascular signaling pathways science to improve health and impact lives around the world.

The Role :

Cardurion Pharma is seeking a talented, independent, and highly motivated Senior Manager, Clinical Drug Supply with expertise in supply chain management to join our Clinical Drug Supply Team. This role will be responsible for managing day-to-day activities related to managing the supply of Clinical Trial Material (CTM) through all stages of clinical development including packaging, labeling and distribution. This position will design, develop, and implement the clinical supplies strategy to ensure appropriate continuous supply of material. They will work closely with CMC / manufacturing, Clinical Operations, Quality Assurance, Regulatory Affairs, Program Management and third-party CMO vendors. Strong cross-functional team leadership and project management skills are essential requirements of the role.

Here’s What You’ll Do :

• Experience overseeing drug management for multiple concurrent open label and double blind clinical trials from first-in-human studies through to pivotal studies, requiring in-depth understanding of GMPs, project management, IRT, drug accountability and supply forecasting.
• Drive the clinical label text creation, translation, label proof, approval process and printing activities for global clinical trials.
• Experience managing and working with Contract Packaging Vendor for depot set up, scheduling and delivery of secondary packaging, labeling, QP services, IRT integration, distribution and return drug management activities at global depots.
• Working with vendors and / or CROs to contribute to the development within the IRT system requirements, user acceptance testing, and drug supply management.
• Responsible for vendor management; including RFP review process, contracts / budget, performance accountability, invoice review and timeline management.
• Develop study Pharmacy Manuals with collaboration from Clinical Operations, CMC and key stakeholders.
• Work collaboratively with CMC, RA, QA to ensure trial supplies are appropriately supported including shelf life, inventories, country approvals.
• Ensure uninterrupted supply availability throughout the duration of a clinical study program.
• Proactively identifies areas for improvements and recommends solutions to emerging issues in an effective manner while taking into consideration risks and cost-effectiveness.
• Manage vendor purchase and change orders that support clinical supplies.
• Manage inventory of clinical supplies and track expiry extensions, temperature excursion, returns, accountability / reconciliation, and destruction.
• Manage the coordination of site close-out activities (reconcile & dispose of IP, collect Certificates of Destruction, ensure 100% accountability at site and vendor inventory)
• Support clinical supply activities for on-going and new clinical trials including demand forecasting, trial monitoring, resupply planning, IRT set-up, distribution activities.
• Ensure on time startup of new studies by having clinical trial material supplies available as required to ensure continuous supply of clinical trial material for ongoing global studies.
• Will contribute to protocol, IB, IMPD review and must have a solid understanding of the clinical supply sections of these documents.
• Must have solid understanding of the QP release process for IP in EU and UK.
• Will provide weekly / monthly updates at program and project study team meetings.
• Multi-tasking skills are essential.

Here’s What We’ll Bring to the Table

Our Mission :

Translate our world-class expertise in cardiovascular signaling pathways into groundbreaking therapeutics for patients.

Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Requirements :

Here’s What You’ll Bring to the Table :