Manager, Clinical Supply Chain Operations
Position: Manager, Clinical Supply Chain Operations
Reports to: Associate Director, Clinical Supply Chain Operations
Location: Role specific, Possibilities include, but not limited to Brisbane/Durham, USA or London, UK or Munich, Germany or Vevey, Switzerland
The Manager, Clinical Supply Chain Operations will work as an integral member of the Aimmune Clinical Manufacturing and Supply Chain team, reporting into Associate Director, Clinical Supply Chain Operations. This role will support the development of investigational drug products used in Oral Immunotherapy (OIT), GI, Biologics and any other new pipeline candidate treatments Aimmune Therapeutics, a Nestle Health Science Company takes on development for. The successful candidate will manage the supply chain activities for investigational medicinal products (IMP) and clinical trial materials (CTM) such as Food Challenge materials used in Aimmune clinical and non-clinical studies.
The core responsibilities include management clinical supply chain distribution for Aimmune studies, liaising with vendors performing the packaging, labeling, distribution, inventory, returns, and destruction of IMP/CTM. The position closely interacts with Aimmune’s Clinical Development/ Operations, Clinical Manufacturing, Quality Assurance, and Regulatory groups, and with external vendors.
- Manage distribution activities for Aimmune clinical studies, troubleshoot depot to site shipments, set rush shipments. Interface with internal and external contacts as required
- Manage labeling (in multiple languages), packaging, inventory, distribution, and reconciliation of IMP/CTM for multi-national clinical studies
- Run and analyze weekly reports, report metrics, maintain planning/forecasting spreadsheets and use eSystems effectively ultimately to ensure uninterrupted continuity of supplies
- In conjunction with Clinical Manufacturing and Supply Chain peers, Clinical Operations and Quality Assurance, develop requirements for clinical study drug and other drug supply as required (GLP, non-GLP non-clinical), including labels, review and approval of packaged product specifications, product shipping and storage specifications
- Develop and maintain IXRS systems by working with Clinical Operations and outside vendors to design and implement the IXRS system used to automate the distribution of IMP/CTM to drug depots and clinical sites
- Maintain and ensure compliance with all applicable CTM material import / export regulations
- Develop new functional SOPs, as necessary, and provide training on CTM to Aimmune staff
- Provide general CMC/Mfg/Administrative support to projects and products, as assigned
Qualifications / Requirements:
- Bachelor’s Degree in applicable discipline and a minimum of 4 years professional experience, or equivalent experience, in pharmaceutical/biotech industry and 2 years of experience with to IMP/CTM clinical supply management
- Experience in managing complex distribution IMP/CTM supply chains for double-blinded, placebo-controlled clinical trials in multiple geographies
- Prior experience with managing the supply chain for IMP/CTM to clinical sites in the US, the EU, and other regions and the demonstrated ability to work effectively in a virtual environment are requirements for the position
- Understanding of CFR and ICH guidelines, regulations and guidelines governing conduct of clinical studies a must
- Demonstrated working knowledge of international regulations governing transport and distribution of CTM materials
- Flexibility to travel on company business as required
Preferred Experience, Special Skills, Knowledge:
- Excellent written and verbal communication skills
- Adaptability, agility, flexibility, independence, and resourcefulness to multi-task to thrive in a dynamic virtual environment
- Strong interpersonal skills and ability to function in a dynamic cross-functional team environment
- Strong computer skills, with proficiency in spreadsheet, presentation and word processing software
- Familiar with IMP labeling requirements
- CSCP/CPM or similar is a plus
- Accuracy and attention to detail is a must
- Experience with GMP manufacture of drug products for clinical use is a plus
- Broad exposure to multiple dosage forms and high number of SKUs is a plus
About Aimmune Therapeutics, Inc.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies. The Company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. For more information, please visit www.aimmune.com.
Aimmune is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.