Open Positions: Senior Manager / Associate Director, Global Clinical Supply
Arvinas is a clinical-stage biopharmaceutical company focused on developing new small molecules ‒ known as PROTAC® (PROteolysis Targeting Chimera) protein degraders ‒ 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. Our 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.
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 and will be located at our headquarters in New Haven, CT.
Key responsibilities of this role include, but are not limited to:
- Direct/oversee and schedule contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials at Arvinas.
- Provide subject matter expertise (SME) in the development of all relevant sections of clinical trial protocols and pharmacy manuals that support all phase I-phase III clinical trials.
- Responsible for forecast planning and real time inventory management of clinical and ancillary supplies to meet near-term and long-term goals and to incorporate risk-mitigation strategies.
- Accountable for aspects related GMP review and release of clinical supplies including: incoming materials, labels, documentation, work in progress and finished goods.
- Provide SME for all queries received from CROs or Clinical Trials Sites with regards to formulation, dosing/administration, and temperature exclusions.
- Evaluate proposals and quotes matching the capabilities of the supplier with the project requirements in terms of quantity, quality, and timing of deliverables.
- As the primary contact with the contractors, manage day-today interactions to ensure that deliverables are completed as contracted.
- Communicate production schedules and identified risks to Project Management and the project team as part of project Integrated Development Plans for specific Arvinas assets.
- Assist with the CMC API Supply Chain interfaces with Drug Product Supply, Quality Assurance, and Regulatory Compliance as needed.
- Participate in strategy discussions to ensure that decisions align with agreed upon business direction and processes.
- Assist in the identification of potential vendors to support an IRT/IXRS capabilities.
- Lead the collection of relevant data and reports from suppliers and contribute to drafting of INDs, NDAs, and associated amendments.
- Minimum 8-10 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.