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- Advance innovative science by pushing boundaries.
- Bring transformative therapeutics to patients in need.
- Provide an environment for employees to reach their fullest potential.
- Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.
- Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.
- Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.
- Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.
- Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through.
- Works closely with the AskBio Clinical Ops team, reviewing clinical trial protocols to understand demand/supply requirements.
- Develops, implements, and maintains the investigational product (IP) demand and supply plans based on the study protocol parameters, such as patient enrollment forecast, study dosing requirements and duration, while identifying and challenging key assumptions and study planning parameters to ensure an optimal tradeoff across cost, risk, and benefit is achieved
- Proactively engages with Clinical study teams to ensure supply options & risks are explored and agreed.
- Challenges planning information at the study level (e.g. patient enrollment forecast, etc.) and helps resolve logistical conflicts to ensure clinical supplies are off the critical path.
- Acts as the study interface with the depot / packager, coordinating activities to ensure clinical supplies readiness and delivery to the clinical site.
- Monitor inventory levels at depots and clinical sites throughout study, assuring supply continuity
- Accountable for setting inventory policies at Depots/Pack Sites on a project basis and responsible for agreeing to and monitoring inventory levels as appropriate to support study complexities
- Serves as the primary point of contact for supply of clinical trial materials with the clinical study teams
- Assist in development of IRT and participate in User Acceptance Testing. Determines the supply packing and distribution strategy for local, regional, and global studies, and incorporates into IRT specifications (as applicable)
- B.S., Science, Business, Logistics or a relevant degree or equivalent experience in a relevant field.
- Minimum 5 years'experience in Life Sciences industry
- Knowledgeable of clinical trial study designs and approaches and their implications for supply chain
- Knowledgeable in the management of investigational product supplies and experience in inventory management
- Strong project management skills
- Demonstrated working knowledge of supply chain and planning principles
- Ability to manage multiple and complex projects that require strong problem-solving skills and creative or innovative thought to address global supply problems
- Knowledgeable in regulatory requirements including Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs) and the Trial Master File
- Knowledgeable and experienced in working with Interactive Response Technology (IRT) systems, especially with respect to supply management and patient randomization.
- Strong organizational and planning skills coupled with strong written and oral communication skills
- Knowledge of the technical challenges with regards to investigational product packaging and labeling.
Clinical Supply Study Lead - Durham, United States - Asklepios Biopharmaceutical
Description
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered.
At AskBio, we've built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson's disease, and congestive heart failure. Our gene therapy platform includes Pro10TM, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.
Our vision: Pioneering science to create transformative molecular medicines.
Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.
Our principles:
The Clinical Supply Chain Study Lead role provides tactical oversight of the end-to-end supply chain for AskBio clinical studies. The Clinical Supply Chain Study Lead is accountable for defining detailed demand and supply plans for investigational medicines and assuring on time delivery per the study milestones.
This role is responsible for developing demand and supply plans that are patient-focused, risk-adjusted, and cost effective, based on the study protocol parameters. The Clinical Supply Chain Study Lead ensures timely execution of the plans and follows through on supply chain performance to ensure the successful delivery of the supply chain, with a focus on quality. The role will be responsible for IRT interface, assuring order fulfillment and delivery to clinical sites.
This role supports Phase I through III clinical studies.
Key Responsibilities:
Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.