At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Associate Director, Patient Operations is accountable to manage onboarding and on-going performance of Apheresis Centers used for BMS Clinical and Commercial Chimeric Antigen Receptor (CAR) T-cell Therapies in Europe.
This role will be based out of the corporate offices in Boudry, Switzerland and will be responsible for hiring and managing the local and/or regionally based team that will perform the related duties for sites across Europe. This position reports to the Supply Chain & Apheresis Lead, Europe CAR-T. Travel up to 30% of time within Europe and 5% outside of Europe may be required.
Come join BMS for this unique opportunity to be part of the team building a leading edge Clinical and Commercial CAR T Platform that serves our patients with novel BMS CAR T Therapies.In this role, your main responsibilities include (but are not limited to):
- Lead the Apheresis Network Operations Team responsible for onboarding and management of BMS's clinical and commercial cell collection site network in Europe.
- Manage the team of Specialist that will work closely with the Commercial CAR-T Affiliates and Clinical Trial teams for collection site onboarding and maintenance programs.
- Ensure team is adequately trained and performing site onboarding and management duties in accordance with BMS global procedures.
- Ensure cell collection site launch plans are developed and maintained to support clinical trials and commercial products.
- Monitor regional onboarding status to ensure compliance with the launch plan and ensure risk mitigation plans are in place for sites where timelines are at risk. Report any issues to Patient Operations leadership and other stakeholders.
- Collaborate with Quality Assurance and Global Quality Compliance to ensure that the cell collection centers are compliant with all necessary regulations and company policies/procedures as applicable.
- Collaborate with other regional Apheresis and Quality heads (North America and Japan) to ensure global procedures, training materials and electronic systems are adequate to support all areas. Ensure local work instructions are written and maintained as needed.
- Implement customer feedback program to support continuous improvement in region
- Track and monitor defined global apheresis related KPI's for the region and ensure action plans are developed and implemented for areas where targets are not met.
- Ensure process or system changes are rolled out to regional collection center network within the required timelines.
- Train internal and external stakeholders on the apheresis processes and requirements
- Undergraduate Degree in Life Sciences, minimum 8 years of experience in a regulated environment either hospital or pharmaceutical/biotech
- Experience working in Cell Therapy, Apheresis or Stem Cell Transplant programs
- Experience working in a regulated environment (cGMP/GCP/GCTP) preferred
- Written and verbal fluency in English
- Good understanding of applicable regulations and standards
- Demonstrated excellent leadership, communication and presentation skills
- Independently motivated, detail oriented and good problem-solving ability
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment.
- Willingness to travel, domestically and internationally (~20-30% of time)
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.