Bristol-Myers Squibb Company

Associate Director, Biologics Analytical CRO Operations Lead

Location
New Brunswick, NJ, US
Posted
May 12, 2018
Ref
R1504990
Required Education
Bachelors Degree
Position Type
Full time
BMS program technical/operational lead to provide oversight of BMS strategic partner CROs (US and Global) for analytical programs spanning from early/late stage clinical assets to commercial asset analytical enabling and commercial testing support when applicable. This position will report to the Lead, External Analytical Strategy and Management (EASM), in the Analytical Strategy and Operations, Product Development, Global Product Development and Supply (GMS) organization. Incumbent is expected to efficiently and independently perform the duties and responsibilities for this role as outlined below.

Responsibilities:
• Work with strategic outsourcing partners CRO(s) to oversee operational and technical aspects of outsourced analytical programs at strategic CRO partners on behalf of BMS. Oversight of project execution and operations-facing activities at external suppliers.
• Work to define and implement KPIs that provide meaningful data aligned with Quality Agreements, SOWs, internal BMS expectations and with program deliverables in a format consistent across the outsourcing analytical network.
• Define/align, implement and monitor trends and key performance indicators across portfolio and outsourcing strategic partners related to issues and successes within each operational/technology category to ensure BMS awareness and visibility to program deliverables (meeting minutes, sample testing status dashboards), timelines (BOW), program risk (high-impact issues log), technical performance (method and sample trending and KPIs), quality events (Quality updates/dashboards) and resource utilization (BOW, TATs, KPIs).
• Work with outsourcing managers, BMS analytical program and validation/transfer leads, key analytical subject matter experts, functional area management/leadership and stakeholders in other BMS functions (MAD, AS&T and Quality, Quality units, Business Operations/Procurement), as well as key stakeholders within partner organizations to identify, escalate and support actions to address gaps in method/program implementation and testing practices for program launch (kick-off meeting slide deck), implementation, and close-out (lessons learned and best-practices) to ensure efficiency gains and program processes/technical improvements are captured, implemented and aligned across the analytical network.
• Assist in the development, deployment, utilization, review and alignment across the analytical network of FTE model capacity and forecasting tools to maintain current resource capacity determinations as well as future resource planning/forcasting tools to enable efficient utilization/redirection of resources, and reprioritization of programs to meet timelines with controlled impact to program deliverables.
• Represent ASO as an active participant on the Strategic Partner Operations Committee to work to create network level clarity and effectiveness on managing strategic partners for analytical services. Support strategic decisions on new approaches and intiatives.
• Utilizing OpEx LEAN strategies to support programs and BMS/CRO organizations to ensure an on-going culture of continuous improvement and alignment across the BMS global outsourcing analytical network. Travel to key strategic partner CROs to enable close communications and avail face-to-face opportunities to provide a sense of purposeful presence
• Serve as key technical/operational interface between BMS and CRO strategic partners to establish and maintain effective, strong working/team relationships, built on a platform of trust and respect. Primary communication conduit for operational and technical issues arising at strategic CROs (not project specific issues).
• Co-lead and drive efficient and effective project review meetings and additional meetings as necessary. Attend analytical team lead meetings to represent EASM to provide feedback and training as requested or appropriate to analytical leads for out-sourced analytical testing. Ensure appropriate communication to development and commercial organizations, and key stakeholders regarding outsourcing strategies and activities. Internally deliver communication, training and stakeholder management of changes with specialty vendors.
• Identify and escalate CRO issues or issues BMS team members are unable to resolve directly with the outsourcing partner, recommend potential solutions as appropriate.
• Collaborate and partner with the BMS quality organization and PPD SMEs/management to provide support, help as an intermediary when requested, and to escalate quality/testing issues arising.
• Manage a team of outsourcing professionals when required.

Qualifications:

• A minimum of a BS Degree in a clinical or scientific discipline (advanced degree highly desirable)

• Minimum 10+ years of clinical drug Development experience as well as broad exposure to the pharmaceutical industry is required. Experience in cell based assay is highly desired.
• First-hand experience of working directly with outsourced analytical Contract Service Providers, strong and effective management of cross-functional, global, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.
• and professional staff
• Strong technical knowledge and experience in analytical method development, qualification, validation and transfer activities to meet established CMC deliverables.
• Comprehensive Good Clinical Practice and Good Laboratory Practice knowledge of regulations and guidelines preferred.
• Demonstrates poise and confidence in conflict situations, has the ability to keep an objective perspective.
• Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate.
• Experience and advanced fluency with Microsoft Office tools (especially MS Excel, MS PowerPoint and MS Project).
• Experience with the OpEx LEAN tools and processes
• Strong project management skills and demonstrated ability to manage project timelines and deliverables using appropriate tools and templates
• Willingness to travel (estimated 10-15% of time) for building and maintaining vendor relationships and assessing vendor capabilities.
• Ability to work off business hours due to time zone differences of alliance partners and internal colleagues.