Job Description

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.

ROLE SUMMARY

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 a Associate Director, Biospecimen Planning colleagues who will work closely with our Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-2a 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 BMSs 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 BMSs continuous competitive advantage. The individual will be responsible for supporting biospecimen management for Early Development assets with opportunities to contribute toward optimizing work streams cross functionally throughout the organization as it relates to biospecimens.

RESPONSIBILITIES



* Develop and document the Protocol Biospecimen Management Plan

* Develop standardization of Biospecimen Management Plan at asset and indication level.

* Core Clinical Team member responsible for providing timely updates on sample collection, analysis, and data integration.

* Act as Biospecimen SME at program and protocol-level for Clinical Biospecimen Operations Team, Pharmacodiagnostic, Companion Diagnostics Team, and Clinical Operations

* Develop visualization of biospecimen and data updates provided to Clinical Team.

* Acts as escalation point for biospecimen assay results for Clinical Team.

* Participates in CAPA findings and resolutions.

* Leads initiative within GBSIM and enterprise-wide to address biospecimen sample and data journey.

* Represent GBSIM team in protocol level meetings and teams on an ad hoc basis

* Independently investigate and develop process improvement for GBSIM

* Manage business complexities and provide road map for sustainable solutions

* 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.

* Directs/manage book of work with team members. Acts as mentor to new hires or line mange.

* Lead clinical protocol study team with review of biospecimen 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.

* Support the implementation of IT capabilities to enhance operational effectiveness, biospecimen tracking, and operational data tracking/mining. Ensures all tasks are documented in alignment with the protocol.

* Operate in a complex matrix organization, lead through influence with excellent communication and negotiation skills and able to resolve conflict in a constructive manner, while keeping a keen customer focused mindset.

* Demonstrates good communication, interpersonal and negotiating skills and leverages those competencies to ensure continuous progress within both internal and external teams

* Travel expectations are minimal, perhaps 5-10% domestic

REQUIRED QUALIFICATIONS AND EXPERIENCE

* 5+ years biotech or pharma industry experience with scientific degree (BS, MS or higher)

* Proven experience working in teams managing clinical studies within the pharmaceutical/CRO industry.

* Experience with SOPs, guidance's and work instructions and ability to draft biospecimen related documents or sections within these documents.

* Must have a strong business partnering orientation with excellent analytic, interpersonal, and communication skill

* Prior experience in biospecimen life-cycle/operations, compliance and management

* Basic understanding of Vendor, Clinical Site, stakeholder management

* Deep knowledge of clinical research, GCP, GLP, CLIA, data management, risk management, and regulatory and legal issues

* Expert in Excel functions; along with good time management, planning, record keeping and organizational skills.

* Deep 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.

* Excellent written and oral communication and presentation skills

* 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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.