Senior Manager, Clinical Supplies
Senior Manager, Clinical Supplies
Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena’s proprietary pipeline includes multiple potentially first or best-in-class assets with broad clinical utility.
The Senior Manager of Clinical Supplies, will independently participate in the review of the clinical trial protocol during its development stage, create clinical drug demand forecast, coordinate clinical label development, provide interactive response technology (IRT) clinical supplies specifications, schedule and manage the outsourced labeling and packaging of clinical trial materials (CTM), manage the overall inventory to ensure the uninterrupted supply of CTM to clinical sites and ensure study timelines are met. The candidate is expected to contribute to the development of the pharmacy manual and providing information to a vendor to request for a quote and managing the vendor.
Arena’s Technical Operations Clinical Supply Chain group is responsible for the supply and management of CTM supporting the conduct of the company’s multiple clinical development programs. The Manager, Clinical Supplies, is a critical, hands-on role within the company. The position will be responsible for coordinating efforts between Supply Chain planner, quality, clinical operations, and regulatory team members to provide timely availability of high quality CTM to clinical study sites and to manage the return and disposition of CTM labeled and packaged for clinical trials.
The ideal candidate will have hands-on experience handling global phase 3 clinical trials, strive for operational excellence, proposing opportunities for improvement and identifying areas of risk through cross-functional collaboration with various functional departments such as QA, Program Management, Regulatory Affairs and Clinical Operations. The role will have exposure to vendor selection process.
What You Will Dive Into:
• Participates in the development of clinical study protocols and pharmacy manuals.
• Interprets clinical study protocol to create CTM demand forecast and develop CTM label and packaging configuration to support the clinical trial, meeting aggressive study startup dates and ensuring uninterrupted supply throughout the conduct of the study.
• Coordinates with the CRO in the development of multinational label text meeting local country
• Defines clinical supplies IRT parameters, reviews the IRT specifications document and conducts user acceptance testing of the IRT for kit assignment, CTM inventory & expiry
• Manages CTM inventory at study depot(s) and site(s).
• Manages outsourced packaging, labeling and distribution of CTM supporting small proof of concept studies and multi-center, multi-national global clinical trials.
• Works with the main distribution depot to set up local depots globally.
• Provides the local depots with the required documentation to import the CTM to the country and clinical site distribution.
• Work with depots and CROs to identify import and export
• Reviews batch records in collaboration with QA to ensure the timely release of the CTM to meet study timelines.
• Collaborates with and QA and CMC Regulatory to provide the European Qualified Person (QP) product appropriate documentation to release the CTM for distribution.
• Coordinates the reconciliation of returns and destruction of CTM shipped back to the depot(s).
• Provides information to a vendor to request for a quote to support the labeling, packaging and distribution of the CTM. Manages the vendor’s customer support and performance.
• Possible travel for packaging and labeling and distribution vendor audits.
What We Expect:
• BA/BS/MS degree
• 7+ years of extensive hands-on experience in handling global phase 2 and 3 clinical supply execution and management/coordination. A combination of clinical supplies and pharmaceutical development areas experience, specifically in CMC will be considered on a case-to-case basis.
• Superior oral and written communication, MS Word and Excel skills.
• Working knowledge of ICH guidelines, GMP's, 21CFR and Annex 13 requirements.
• Knowledge of vendor selection process and management.
• Ability for occasional travel.
• Experience with controlled ambient and cold chain shipments.
What We Offer:
• To be part of a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
• Opportunities to learn and contribute to creative solutions
• Competitive compensation package including long-term incentives
• Comprehensive health insurance (highly subsidized cost sharing on all medical plans)
• Generous matching 401k retirement plan
• Flexible time off policy and holidays including two company-wide shut-down periods each year
• Multi-cultural work environment
• Company celebrations
Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at email@example.com.