Manager / Senior Manager, Global Clinical Supply
Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes two clinical-stage programs: ARV-110, which is being developed as a potential treatment for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 200 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.
We are currently seeking an experienced Global Clinical Supply Professional to join the Clinical Operations Department at Arvinas who will work closely with numerous core team members to develop dose preparations and dosing schedules for planned or ongoing clinical trials at Arvinas. This role will take the lead on developing pharmacy manuals and relevant sections in clinical trial protocols that serve as the key piece for clinical trial sites and ultimately patients to ensure correct drug attributes, dose formulations and proper administration are available. This position will serve as a core member of multidisciplinary project teams and will directly impact strategy, timing, and execution of all planned or ongoing clinical trials. This Clinical Operations position will closely interface with internal or external departments such as Quality, Product Development, Regulatory Affairs and Contract Research Organizations (CRO’s) to ensure dosing plans as well as inventory are made available to support clinical trial strategy and timelines globally. Responsible for actively managing all deviations, clinical supply investigations, Corrective Actions and Preventative Actions (CAPA’s), and any required Change Control documentation, when required. This position will work closely with the members of Chemistry Manufacturing and Controls, Manufacturing and Supply (CMC) and Chemical Process R&D. The incumbent will ensure all activities occur in compliance with the appropriate SOPs and regulations.
This position reports to the Senior Director, Clinical Operations at our headquarters in New Haven, CT and may be performed remotely from a location within the U.S.
Key responsibilities of this role include, but are not limited to:
- Assist CMC with contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials at Arvinas.
- Leads the planning, creation, and maintenance of IMP supply project plans, based on study forecasts with Clinical and Medical project managers and contract providers.
- Assist Quality Assurance (QA) activities related to open and close of Deviations, Investigations, CAPA’s, Change Controls, Label and Product Specifications, and others as required.
- Direct and monitor clinical supply contractor set up, progress and implements corrective actions when issues arise.
- Manages development and implementation of IVRS supply and drug return strategy with contractors and sites.
- Manages Clinical Supplies inventory for projects assigned by interfacing with contractor to ensure that inventory systems are kept up-to-date, and that final product reconciliation is accurately completed.
- Interacts with Clinical sites, caregivers and patients regarding supply needs, storage and return of clinical supplies.
- Develop Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, disposition of returned/unused materials.
- Ensures that key supply project milestones are met; negotiates and communicates supply plan timelines to internal and external customers and partners.
- Proactively drives cross-functional activities. Works with other line functions and external partners to manage complex projects.
- Participates as SME for clinical regulatory audits related to supply.
- Represents Clinical Supplies on global clinical project teams.
- Assist Associate/Director Head of Clinical Supply with forecast planning and real time inventory management of clinical and ancillary supply, identify process improvement opportunities, recommends pathways for solutions, and drives idea generation, proposals, and implementation.
- Minimum 5 years of related pharmaceutical industry experience
- A successful track record in investigational drug services (preferably in the Bio-tech space)
- Demonstrated experience in global inventory management and forecasting.
- Comprehensive working knowledge of Good Manufacturing Practices (cGMPs) and regulatory guidance documents as they relate to manufacture, labeling and quality testing of pharmaceutical products.
- Ability to effectively prioritize and deliver on tight timelines
- Outstanding problem-solving abilities
- Detail-oriented, with good organizational and project management skills
- Strong oral and written communications skills
- Proficient with MS Word, PowerPoint, Excel
- Strong leadership, project planning, negotiation and presentation skills
- Significant experience in communicating/presenting complex information to senior management and regulatory agencies.
- 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
- Ability to be proactive in identifying issues and hurdles that may hinder the effective progression of an asset and resolve the issues in a timely and creative fashion
- A BS/BA degree or PharmD with prior clinical supply, hospital or investigational drug service experience preferably in a bio-tech environment.
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