Associate Director Clinical Supplies – Zafgen Inc – San Diego, CA, USA
Zafgen is a biopharmaceutical company leading the way in addressing the unmet need of severely obese patients by bringing beloranib, a first-in-class novel medicine, to market to help patients live longer, better lives. Our purpose as a company is to collaborate with the world’s leading obesity and metabolic disease experts from academic institutions and contract research organizations to apply the best thinking to advance our understanding of the molecular mechanism of our obesity treatment program. This thinking is embedded throughout all aspects of our clinical trials, which are designed to evaluate the safety and efficacy of beloranib in severely obese patients. Additionally, we have a second program focused on the delivery of MetAP2 inhibitors with targeted tissue distribution that shows early promise in animal models of NAFLD, NASH and abdominal obesity. Our lead MetAP2 inhibitor in this class of molecules is called ZGN-839. We also plan to advance multiple candidate drugs into early development to establish clinical proof of concept, safety and tolerability of these molecules as a way to leverage our internal know-how in metabolic disease and the effects of MetAP2 inhibitors.
We look for talented people to grow our business, advance our science and contribute to our unique culture.
Zafgen is looking for an Associate Director of Clinical Supplies. This position will report to the Head of Program Management. The individual will be responsible for all aspects related to Clinical Supply Chain and will serve as a key customer liaison with multiple functional areas. The successful candidate will be a self-starter with excellent organizational skills and attention to detail.
Responsibilities will include but are not limited to:
• Responsible for clinical supply activities including coordination of packaging, labeling, and distribution at Contract Packaging Vendors and destruction as required.
• Create, review, and update clinical supply requirement plans in partnership with Manufacturing and Clinical Operations.
• Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, etc. and ensure changes in requirements are considered.
• Might be called upon to prepare and/review clinical protocols and clinical trial pharmacy manuals, packaging methods, drug labels, shipping documents, and etc.
• Establish metrics and monitor performance such as drug wastage.
• Monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues.
• Prepare and manage program budget.
• Review and approve contracts for packaging and labeling activities conducted by clinical supply vendors and monitors budget.
• Participates in audits and monitoring of clinical supplies vendors.
• Reviews and approves IVRS specifications from investigational materials perspective.
• Partners Regulatory and external vendors to coordinates the design of clinical labels to meet protocol, FDA, EU and country specific requirements.
• Partners with Manufacturing, QA, and clinical operations to monitor clinical supplies inventories and expiry/retest dates of supplies.
• Creates, reviews and revises clinical supplies SOPs as appropriate
• Required Bachelor degree with 10 years of experience or Master of Science degree with a minimum of 7 years of experience in regulated industry.
• A minimum of 5 years’ experience in directly managing Clinical Supply Chain.
• Experience with parenteral and blinded clinical supply packaging including Ex-US is a plus.
• Experience and familiarity with cGMP practices and knowledge of CFR, ICH, CDER guidelines for storage, handling, and distribution of drug products.
• Ability to review clinical protocols to assess clinical supply needs.
• Experience with IVRS systems is required.
• Experience in refrigeration materials (cold chain management) is preferred.
• Working knowledge in global import/export requirements.
• Strong working knowledge with Excel is preferred.
• Strong interpersonal and communication skills for bridging between scientific and business participants, for negotiating timelines and for effective collaboration.
• Strong verbal communication, project management, and organizational skills is required. Expert in written communications.