Open Positions: Manager / Associate Director, Clinical Supplies
Arvinas is a pharmaceutical company focused on developing new small molecules ‒ known as PROTAC®s (PROteolysis TArgeting Chimeras) ‒ aimed at degrading disease-causing cellular proteins via proteolysis. Based on innovative research conducted at Yale University by Dr. Craig Crews, Founder and Chief Scientific Advisor, the company is translating natural protein degradation approaches into novel drugs for the treatment of cancer and other diseases. The proprietary PROTAC®-based drug paradigm induces protein degradation, rather than protein inhibition, using the ubiquitin proteasome system and offers the advantage of potentially targeting “undruggable” as well as “druggable” elements of the proteome. This greatly expands the ability to create drugs for many new, previously unapproachable targets. For more information, visit www.arvinas.com.
The Supplies Manager is responsible for supporting the manufacture, forecasting, inventory management, labeling, packaging, and logistics of non-clinical and clinical supply requirements. This position works closely with Clinical Development Operations, API and DP Development, External Manufacturing, and Quality Assurance along with a variety of external CDMOs to implement the preclinical and clinical strategies for drug development programs and products. The incumbent will serve as a core member of the development team and be the key contact for clinical supplies at Arvinas. The incumbent will ensure that all activities occur in compliance with the appropriate SOPs and regulations.
This position reports to the Senior Director, CMC External Manufacturing and Supply and will be located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- Serve as the lead for the clinical supply planning, including demand forecasting. Manage supply planning and timelines to ensure alignment with study plans and timelines and the overall clinical development plan.
- Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines
- Provide input to the development of IP-related study documents including protocols, study and pharmacy manuals
- Oversee setup and management of IRT sytems e.g. IVRS and IWRS. Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors.
- Manage and track investigational product (IP) inventory. Advise of potential shortages and make recommendations for resupply activities based on usage trends. Monitor and manage clinical supply activities through IRT, when appropriate, from study start-up through study closure. Ensure appropriate system documentation is available for the TMF and inspection readiness.
- Oversee IP shipment orders according to supply plans or as requested by the Clinical Development Operations team, to ensure timely and compliant shipment and delivery to investigator sites. Manage all aspects of the process.
- Review and evaluate temperature excursion data with Formulation Development and Quality Assurance and communicates drug disposition to clinical trial managers, CROs, and investigator sites.
- Review drug return and destruction records; communicates with investigator sites, CROs and external vendors to resolve issues.
- Authorize final destruction of drug returns at 3rd party vendor.
- Monitor IP expiry data and informs DP Manufacturing and Clinical Trial teams of pending IP expiry.
- Assist in the preparation of RFPs, bid review, and contract content for packaging, labelling, and distribution.
- As needed, assist the Sr. Director External Manufacturing and Supply in the preparation of RFPs, bid reviews, and contract content for API and DP development and supply.
- Experience developing drug trial supply plans
- Must possess Investigational Product forecasting skills
- Experience in the development of specifications and testing of IRTs
- A working knowledge of the drug development process and clinical trial methodology
- Knowledge of ICH, GCP, GLP, GMP, and regulatory guidelines/directives
- Knowledge of global clinical labeling requirements
- Knowledge of Oncology and Neurodegenerative Disease areas are a plus.
- Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation and/or progression of a study and resolve the issues in a timely and creative fashion
- Ability to effectively prioritize and deliver on tight timelines
- Ability to multi-task and manage several projects in parallel, paying attention to detail
- Ability to forge cross-functional working relationships with internal and external project partners
- Good oral and written communications skills
- Must have experience in using computers and databases for data collection, compilation, analysis, and information dissemination
- Proficient with MS Word, PowerPoint, Excel
- BS/MS/PharmD and at least 6 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness, and financial security of our employees and their families. Benefits include group medical, vision, and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com.
Arvinas is an Equal Opportunity Employer.