Director Global Clinical Supply Chain Operations

Position Snapshot

Location: Vers-chez-les-Blancs, Switzerland
Company: Aimmune, Nestlé Health Science
Permanent contract
Full-time, Act. Rate 100%
Bachelor’s Degree in applicable discipline
Travel required, up to 25%
At least 10 years of combined Medical nutrition and/or Pharmaceutical industry experience with 5 years of which were within the Clinical Supplies/Manufacturing specialty

Position Summary

Nestlé Health Science is a leader in the science of nutrition, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Headquartered in Switzerland, we have more than 11,000 employees around the world, with products available in more than 140 countries.

Aimmune Therapeutics is the pharmaceutical unit of Nestle Health Science (NHSc), with a focus on the advancement of treatments for food allergy, GI disorders, and other food-mediated diseases. We are continuing to build a world-class R&D organization with a strong development infrastructure to support programs in gastroenterology, food allergies and other metabolic & inflammatory diseases. The R&D function within Aimmune Therapeutics drives development activities related to the pharmaceutical pipeline.

The Global Lead, Clinical Supply Chain Operations will work as an integral cross enterprise member in Nestle Health Science, whilst sitting within the Aimmune Clinical Manufacturing & Supply Chain (CM&SC) Operations team. This role will aid in the development of the newly appointed Medical Nutrition (Nx) arm of the CM&SC organization as well as providing ongoing pharmaceutical program execution within the team.

The scope of this role includes both investigational pharmaceutical drugs and medical nutrition products as part of Nestle Health Science and Aimmune Pharma pipeline portfolios.

As Global lead, Clinical Supply Chain The successful candidate will proficiently support various manufacturing & clinical supply operations across Oral Immunotherapy (OIT) & Gastrointestinal (GI) and other newly added pipeline treatments for investigational medicinal products (IMP), Investigational Nutritional Products (INP), Clinical Trial Materials (CTM) and Food Challenge Materials (FCM) used in Aimmune/NHSc clinical and non-clinical studies. The position closely interacts with NHSc teams & Aimmune’s Clinical Operations, Product Development, Manufacturing, Quality Assurance, and Regulatory groups and with external vendors.

A day in the life of a Director Global Clinical Supply Chain Operations

• Identify & develop processes (SOPs and WoWs) to bridge Rx/Nx Clinical Supply Operations within compliances of product appropriate regulations
• Align cross functionally and with CM&SC Ops colleagues to set program level strategy for forecasting, production planning, storage and distribution setup, packaging, labeling, returns, and destruction of IMP/INP/CTM
• Ensure IMP/INP traceability, accountability, and compliance to GCP requirements and applicable GMP requirements
• Ensure continuity of clinical and non-clinical supplies with on-time/on-budget delivery performance. Including, but not limited to forecasting demand to manufacturing team, and overseeing storage & distribution activities, troubleshooting escalated issues, continuously providing and monitoring KPIs
• Driving hands on results and results through others by being accountable for global clinical trial supplies availabilities, inventories with demand and manufacturing forecasts
• Ability to direct, project manage, influence and represent Aimmune CM&SC’s team objectives among cross functional NHSc teams in Nestle HQ, Aimmune, CMOs and global corporate offices, as required
• Ability to be PIP in Pack/Label facilities, liaise with QPs as point person for Aimmune external vendors
• Accountable for labeling (in multiple languages, and over labeling), packaging, inventory, distribution, and final reconciliation of IMP/INP/CTM for multi-national clinical studies as assigned
• Ensure program appropriate import and exports maintain and ensure compliance with all applicable Clinical Trial Material import / export regulations
• People Manager: Hire, train, retain and inspire existing and future CM&SC Ops staff assigned
• Lead efficient procurement of study related ancillaries, such as but not limited to food challenge materials

What will make you successful

• Bachelor’s Degree in applicable discipline
• At least 10 years of Medical nutrition or Pharmaceutical industry experience with at least 5 years of that within the Clinical Supplies/Manufacturing specialty
• Robust interpersonal skills and ability to communicate and work effectively in a global multi-functional team environment
• Experience in managing complex products, Mfg & distribution supply chains of IMP/INP/CTM for global double-blinded, placebo-controlled clinical trials in multiple countries
• In-depth knowledge of Medical Nutrition guidelines, regulations, operations, and Ways of Working (WoWs)
• Understanding of Annex 13, 15, 16 as well as ICH guidelines, global label development regulations and guidelines governing conduct of clinical studies a must with experience in cold chain logistics.
• Demonstrated proficient knowledge of international regulations governing transport and distribution of IMP/INP/CTM CTM materials
• Flexibility to travel domestic and internationally on company business as required
• Strong project management and computer skills, with proficiency in Microsoft Office Suite; specifically, advanced Excel, Word, PowerPoint and Project
• Experience with GMP manufacturing for clinical use is a must, food and/or pharmaceutical
• Accuracy and attention to detail, adaptability, agility, flexibility, independence, and resourcefulness to multi-task as needed to thrive in a dynamic global and virtual company environment is a must
• MBA, MSc, CSCP or CPM Certification or similar is a plus

About us

Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies and food digestion & absorption. Aimmune has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies. In the area of food digestion and absorption, we offer treatments for Exocrine Pancreatic Insufficiency (EPI), a disorder where the pancreas does not make enough enzymes due to cystic fibrosis or other conditions. For more information, please visit www.aimmune.com.
Nestlé Health Science is a leader in the science of nutrition, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Headquartered in Switzerland, we have more than 11,000 employees around the world, with products available in more than 140 countries.

Nutrition can be life-transforming for those who need extra support during short- or long-term medical challenges, and it can enhance the quality of life of those who are already healthy. With an extensive research network providing the foundation for products that can help people to live their healthiest lives, our commitment to science-based products means that we provide nutritional solutions that can make a real difference in the quality of life of customers, patients and caregivers.