Manager, Biospecimen Planning Management
- Princeton, NJ
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.
We are developing a world-class Global Biospecimen and Imaging Management (GBSIM) organization within Global Development Operations (GDO) to drive excellence and innovation in end-to-end biospecimen and imaging management to support the objectives of both Research and Development. Planning and operationalizing the clinical trial biospecimen plan is critical to support these objectives are key.
As such, we are recruiting Biospecimen Planning colleagues who will work closely with our Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-4 clinical trials and externally acquired biospecimens. Members of this team will develop and execute asset and protocol-level biospecimen strategies and work across the organization and with BMS's partners to implement and project manage efforts to execute these strategies. Critical to this role is the ability to provide innovative solutions to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring BMS's continuous competitive advantage. The individual will be responsible for supporting biospecimen management for the Late/Full Development assets within Heme, Oncology, Immunology, Cardiovascular, and Fibrosis. Colleague will have opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens.
- Develop and document the Protocol Biospecimen Management Plan
- Core Clinical Team member responsible for providing timely updates on sample collection, analysis, and data return.
- Work closely with Clinical Biospecimen Operations Team, Pharmacodiagnostic, Companion Diagnostics Team, and Clinical Operations, to provide timely updates and coordinate sample movements needed for analysis or long-term storage
- Work closely with the GBSIM Team and the clinical study teams to address informed consent and IRB/EC questions related to biospecimen
- Represent Global Biospecimen group in protocol level meetings and teams on an ad hoc basis
- Planning, coordinating and overseeing all planning activities required to manage the lifecycle of biospecimen samples (collection, processing, analysis, data delivery and cleaning process, and final sample disposition)
- Ensuring review of lab specifications and manuals as well as sample handling training and collection/processing materials for investigator sites/monitors together relevant internal and external stakeholders and the central lab.
- Assist clinical protocol study team with study related documents, training of sites, queries, regulatory issues/concerns, and audits.
- Manages and owns study start up process with Clinical Team, including performance monitoring and issue escalation.
- Demonstrates good communication, interpersonal and negotiating skills and leverages those competencies to ensure continuous progress within both internal and external teams thus moving issues to resolution
- Travel expectations are minimal, perhaps 5-10% domestic
REQUIRED QUALIFICATIONS AND EXPERIENCE
- 3+ years biotech or pharma industry experience with scientific degree (BS, MS or higher).
- Experience preferred in biospecimen life-cycle/operations, compliance and management
- Basic understanding of Vendor, Clinical Site, stakeholder management
- Basic understanding of clinical research, GCP, GLP, CLIA, data management, risk management, and regulatory and legal issues
- Demonstrated knowledge of Excel functions; along with good time management, planning, record keeping and organizational skills.
- Good knowledge of clinical biospecimen procedures and lifecycle including: collection and tracking procedures, logistics considerations, chain of custody, issue escalation/resolution and data management highly desired.
- Ability, willingness to learn; strong desire to grow and develop skills.
- Good written and oral communication skills; preferred basic experience in developing training and/or informational material and presenting to both internal and external stakeholders.
- Experience and fluency with MS Office tools (esp. MS Excel, MS PowerPoint)
- Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with a sense of urgency, accountability and integrity, and to have fun along the way.
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.
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