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
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), Delta Dental, and vision offered through VSP
- Fully funded HSA for high-deductible PPO Plan
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 4 weeks Paid Time Off annually
- 401k (traditional and Roth offered) with 50% match on first 4% deferred. Match is vested immediately
- A suite of Cardurion paid insurance coverage, including: life insurance, short-term and long-term disability
- 10 company paid holidays and Year-End shut down
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:
- BA/BS degree, 5 + years of relevant experience in clinical supply chain management in the biopharmaceutical industry associated with complex global trials.
- Anticipates and proactively identifies, recommend creative solutions or escalate issues for project resolution.
- Ability to effectively prioritize and manage multiple projects and tasks.
- A flexible approach to problem solving and strong negotiations skills.
- Excellent oral and written communication skills required with the ability to effectively understand and present information and deal confidently with internal and external stakeholders.
- Initiative, excellent attention to detail, with excellent problem-solving ability and highly developed organizational and time- management skills are required.
- Strong computer skills in the use of Microsoft suite of programs (Word, Excel, Outlook, PowerPoint, Smartsheet/MS Project), with demonstrated expertise in creating and using spreadsheets for material planning and forecasting.
- Thorough understanding of regulatory requirements for clinical supply distribution in US, EU and APAC including labeling requirements is a plus.
- Travel may be required but is not expected to exceed 10% for Face-to-Face meetings with CRO and/or Investigator Meetings as required.
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