US-NJ, Global Head of External Relationship Management 235240BR-MZ
Global Head of External Relationship Management
Global Drug Development
East Hanover, NJ
Research & Development
External Development Operations (EDO) Global Head EDO
The Global Head ERM has overall accountability for the management of outsourced ac-
activities and deliverables for the selected services across all program teams and trials in Global Drug Development (GDD) with External Service Providers (ESP). In addition, the Gl Hd ERM Lead will oversee single strategic providers delivering multiple services across multiple categories
1.Accountable, for assigned services or categories, External service strategy meeting the needs of GDD and beyond GDD stakeholders, driving value beyond cost.
2.Accountable for driving ESP oversight, governance, and issue management / escalation across the Novartis Pharma Development portfolio spanning across multiple therapeutic/ disease areas and phases of development.
3.Accountable for the development, innovation, productivity and optimization of ESP processes, services, relationships and performance to enable high quality ESP outputs, enabling clinical trial excellence across Novartis. Build and main- tain a strong partnering with Novartis divisions (e.g. NIBR).
4.Provide strong and consistent support to the goals of the EDO and the individual business teams ensuring a delivery of purchased services to the required quality, time and cost that supports trial delivery with optimal productivity across the en- tire development organization.
5.Provide oversight of the ESP landscape and capabilities across GDD and perform oversight and management activities to ensure Novartis gains access to best in class services and performance delivering sustainable value.
6.Maintain clear consistent communication with each ESP organization and have a degree of familiarity with the structure and processes of the selected ESPs; de- velop aligned performance measures and report internally
Leadership in single category optimization/ ESP footprint development & over- sight:
Define category strategy, implement appropriate governance and KPIs at a category level & apply consistently across the supply base
Provide a development wide overview of ESP footprint and actively manage to drive consolidation, with a small number of strategic partners
Proactive ESP risk management, assessing trends, quality issues, and busi- ness contract issues, driving ESP s quality improvement.
Aggregate data on provider performance, issue escalation and audit from the clinical trial / function level to drive continuous improvements and report key KPIs/KQIs to EDO Operations
Represent GDD at Executive Level Governance and sub Committees to inform on performance of studies/programs, propose modifications on investments or engagements when required. The Gl Hd ERM will be the final point of con-
tact for escalation of issues not resolved at operational committees. Liaise with
Procurement to plan appropriate meeting agendas
Ensure the external supplier relationships with key partners focus on holistic value-add service rather than cost only
Provide subject matter leadership to EDO for ESP qualification and re- qualification
Provide robust planning activities to ensure savings targets in partnership with the business and NBS
Support activities for HA inspections/Audit readiness
Partner with EDO Operations to ensure performance data aggregation and review requests for new ESPs outside of the approved ESP strategy.
Lead and document regular External Relationship Management Team (ERMT) meetings to ensure continued governance and oversight of selected ESPs
Provide guidance and mentoring support to the ERMT community
Daily functional management of EDO Managers
Franchise strategy development:
Partner with Franchise teams to assess overall program portfolio, and estab- lish program and trial ESP model and strategy
Identity optimizations, synergy and opportunities at the Franchise or Pro- gram level
Partner to acheive optimal quality, cost and performance at a Program level
Implement program ESP strategy
Establish and Develop Collaborative Partnerships
The Gl Hd ERM will drive a core team of direct and indirect multidisciplinary functional experts across multiple divisions, focused on best in class delivery of externally provided services to GDD teams at study, project and enterprise level
For CTT level ESPs (Central Labs, eCOA, Imaging, Diagnostics, etc.), the Gl Hd ERM is accountable for coordinating the activities and feedback of the divi- sional ERMT members, including productivity, savings, KPIs, standards, and centralized operational meetings.Leverage knowledge, experience, under- standing of external stakeholders, internal team capabilities and portfolio needs to develop a compelling, innovative vision and strategy for the ERM cat- egory or service
Support business partners and ESP in issue remediation. Work with QA to ensure CAPAs are appropriately implemented
Successfully supports both the ERMT and service provider to achieve key program milestones according to contract scope
Ensures ERMT operates as a High Performing Team
Participates in decision making sessions with other key internal partners and collaborates successfully with key internal/external key partners
Proactive adaptation of key project goals within budget and productivity tar- gets agreed by the GDD under supervision of their manager.
Demonstrates and supports / reports savings to GDD through productivity initiatives across Novartis
Proactive management and reduction of ESP footprint
Overall KPI/KQI performance management, including improvements, issue management, and escalation
Defines and shares best practices and standards for cross-divisional opera- tions
Strengthening of talent within global teams and operational support func- tions
Visible participation in cross-development management initiatives
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelor s degree required; Relevant advanced degree (MBA, PharmD, MD or PhD preferred)
English: fluent written and spoken
10+ years relevant industry experience, including expertise in clinical operations leadership of multidisciplinary teams, experience management outsourced trial activities at an operational and strategic level
Proven people leadership in ESP management
Experience with clinical processes and associated ESP services, with excellent understanding trial management, trial monitoring and overall integration of clinical data system and processes
Strong technical and problem solving skills Excellent understanding of clinical trial methodology, GCP and medical terminology
Excellent understanding of clinical dev., quality & regulatory standards and policies relevant to defined Services
Proven ability to effectively lead major non-clinical initiatives requiring EDO expertise and processes
Provide thought-leading insights to the competitive environment and internal partner interfaces
Outstanding skills to facilitate/optimize contribution of team members as individuals and members of cohesive team
Excellent interpersonal and communication skills, able to naturally bridge scientific and business participants; Track record in enabling effective international collaboration
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