Clinical Supplies Manager in San Diego, CA

$80K - $100K(Ladders Estimates)

Catalent Pharma Solutions Inc   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 3 days ago

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Job Title

Clinical Supplies Manager (Remote Role)

The Clinical Supplies Manager will be performing the activities required to provide leadership and support in the planning, development, and execution of clinical supply chain activities and the ability to drive cross-functional deliverables and manage activities of supply partners and functions (e.g. packaging and distribution, depots, logistics). The CSM is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials. The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise.

The Clinical Supplies Manager's role is critical to our patients. Management of clinical drug supply in order to maintain a successful trial with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!

The Role

  • Understand and translate clinical study protocol requirements into demand for drug product within a clinical study
  • Create initial study drug projections and supply plan for clinical supply needs throughout life of study including multiple drug campaigns and appropriate drug strategies
  • Assist in re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrollment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans
  • Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug
  • Provide input to IRT specification design. Recommend IRT threshold levels and optimizes as required to make efficient use of clinical supplies while avoiding stock outs at study sites
  • Coordinate with client and packager to forecast, plan and scheduling of packaging campaigns and drive timeline to desired deliverable

The Candidate

  • Bachelor's degree in a science, supply chain or related discipline
  • 6+ years of relevant industry experience with at least 4 years in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle preferred
  • Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management
  • Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR),
  • Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical supply
  • Skilled in client relationship management and ability to influence customer demand
  • Excellent interpersonal skills and problem solving/decision making skills

Catalent's Standard Competencies:

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Position Benefits

  • Lots of Growth/Development opportunities
  • 19 Days of PTO (Paid Time Off) per year
  • Tuition Reimbursement Program
  • Cross-functional exposure across Catalent
  • Employee Stock Purchase Plan

Valid Through: 2019-11-7