Manager, Clinical Supply Chain
The Manager, Clinical Supply Chain will be a hands-on leader capable of leading a small team while contributing directly as the company grows This role encompasses management of all clinical programs from a supply perspective and regularly cross-functional engagement throughout the organization. Specifically, this role will be crucial in developing the clinical trial material demand plan as dictated by the clinical trial protocol as well as “translating” the clinical protocol into “real” demand that can be translated to CMC-technical operations and leveraged to create a manufacturing schedule to support the amount of material needed. This role will encompass supply from the first mile of raw material inputs into production through the last mile of delivery to the patient. This also includes overseeing the logistical aspects of key raw material shipments and investigational product shipments to the depot and clinical sites as well as ensuring every patient in the trial receives product.
**Please note, Precision BioSciences mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.
Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
- Manage a small team of planners and logistical specialists that will grow with clinical programs
- Develop our distribution depot strategy across all programs and enable said strategy
- Deliver CTM to 100% of patients as scheduled
- Develop and manage material demand plans across all clinical programs
- Translate CTM demand plans into forecasted needs for drug product intermediates and raw materials for our manufacturing organization
- Coordinate critical raw material inputs such as clinical grade Leukopaks to our manufacturing suite
- Develop, implement and continuously refine forecasting and inventory management tools via excel based tools and/or appropriate
- Recommend our manufacture schedule in concert with our manufacturing organization and move it through endorsement with Sr. leadership
- Collaborate with clinical operations and the program teams to evaluate study changes and the impact to the supply forecast
- Manage depot and site level investigational product supply including the returns and destruction processes
- Develop strategies for supply through all phases of development
- Develop and execute CTM lot selection strategies to meet our complex clinical trial material needs for each patient
- Be an example of Precision’s Core Values, throughout the work performed and decisions made, leading by example
- Proactively raise issues and concerns, while bringing solutions to the table whenever possible
- Lead cross-functional interactions with key stakeholders (e.g. Development Program Leads, Clinical, Manufacturing, Regulatory, Quality) to support product life-cycle needs
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
- Bachelor's degree in business, engineering or life sciences and 8+ years of experience in operational roles in the Biopharmaceutical industry including GMP supply chain across all product lifecycle phases and multiple geographies including North America and Europe; or equivalent combination of education & experience
- Excellent working knowledge of cGMP's and pharmaceutical industry procedures and regulations
- Experience with clinical trials and developing demand models based on changing clinical protocols
- Ability to plan, budget, and organize strengths in supplier negotiations, Materials Resource Planning
- Experience with Microsoft Office Suite, ERP systems such as SAP, Sage, and NetSuite, and Real-time Visual Supply Chain and Inventory Management Systems (IRT/RTSM)
- Strong excel / smartsheet based modelling skills to support forecasting/ tracking
- Good understanding of Quality Systems and demonstrates proficiency in application of QA principles, concepts, industry practices, and standards. Good conceptual, strategic, analytical, problem solving, and organizational skills.
- Excellent communication skills, both verbal and written, and the ability to interface effectively with all level of the organization. Strong communication skills with outside contract organizations is required.
- Strong personal alignment with Precision’s values, mission and vision
- When company travel resumes, this position will require travel (up to 20%)
- This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed.
Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com
Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.