Patient Solution Leader

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Date: Jun 11, 2019

Location: Slough, Berkshire, GB

At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting with patients and their families around the world living with the physical and social burdens of severe disease of the immune system and the central nervous system. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help to transform lives.

 

Role Overview

The PSL will drive innovation and promotes SMART Risk Taking.  Monitor and evaluate external ecosystem for advances in drug development approaches and applies as appropriate.  Lead early development projects from candidate selection ( DP3)  through to handover to transfer of the project to a mission, termination or outlicensing.  ( In certain circumstances, the PSL may transition to lead the project until to MAA/NDA approval.

 

This role can be located in; UK, Belgium, Germany or Boston, US.

 

The PSL owns the TPVP and is accountable for leading the matrix development team within New Medicines to ensure the global development plan is appropriately designed, internally aligned, risk managed, optimized, and implemented, including:

  • Alignment with TPVP and thereby delivers a patient focused, clinically meaningful differentiated medicine by ensuring appropriate Evidence Plans are developed, reviewed, approved and implemented
  • Is in line with UCB Strategic Plan to optimize the patient value (i.e. focused on sub-populations and clinical differentiation, through application of New Development Paradigm)
  • Scenario planning based on understanding of key risks and sensitivities
    The development of medicines covers non-clinical development, CMC/formulation development,  clinical development, Real World Evidence, device and solution development, regulatory- and access-related planning, external interactions and negotiation, coordination of internal and external interaction to gain insight, support and socialization of development projects and execution of plans to the highest quality and GxP standards.

 

Lead a matrix project team which may include e.g. clinical strategy, statistics, clinical operations, regulatory, CMC, non-clinical development, medical affairs, patents, communication and access team members.

Primary Responsibilities

Accountable for leading the matrix Patient Solution Team and for design and implementation of the development/evidence plan that will deliver in line with the requirements of the TPVP.  To deliver the overall solution plan in line with agreed timing and the budget

  • Clear business case for a differentiated asset
  • Customer insights and needs in core indication(s)
  • Commercial potential/competition assessment
  • TPVP (including target value proposition and key differentiators)  
  • Development strategy with launch insight and integrated development plan
  • Key risks and mitigations 
  • Design and planning (incl. translational and biomarker development as needed)
  • Robust plans for PoC(s)
  • Budget & resource requirement and management 
  • Go/No go decision tree

 

The PSL will ensure that pre-transition scenarios are developed (in line with TPVP) to support clear go-/no-go decision at POC and at decision points thereafter through timely implementation of confirmatory development plan. 

 

Working with the Development Lead, deliverables to support transition include;

  • Base upside and downside development scenarios, including application of NDP value drivers where appropriate with an understanding of their sensitivities
  • Initial CDP to include critical success factors for progression at subsequent milestones and oversight of production of other Evidence Plans and Integrated Evidence Plan
  • Regulatory strategy, scenarios and HA / payer interaction and negotiation plans
  • Sensitivity analysis (Risk/Time/Cost) for the ability to deliver the TPVP in a timely cost efficient manner that provides patient value, examining subpopulations as appropriate
  • Accountability for development plan with appropriate budgeting and project planning, its presentation to governance committees and its implementation and delivery to time and budget
  • Ensuring an innovative development plan is designed and implemented in an efficient manner, applying NDP principles and drivers, that delivers a differentiated TPVP and that meets Patient and Stakeholder (Regulator, HTA, Payer, Physician) needs
  • Decision criteria and framework across the development value chain to ensure appropriate risk based decision making and stage gating
  • Continual improvement of communication practices, internal and external connectivity and methods to increase depth of role and program understanding in the teams
  • Anticipation of business needs to optimally manage costs and people resource

 

 

Essential Requirements

  • Extensive drug development experience as a pharma professional in different environments and been shown to deliver results.
  • Significant research and early (and ideally late) development expertise, gained within a pharma / biopharma environment. 
  • Proven track record in drug development, regulatory interactions, successful matrix leadership and demonstration of core attributes as above.

 

Specific skills/competences

  • Strategic mindset
  • Strong project delivery mindset and project management understanding
  • Ability to create a big picture vision and strategy and then inspire others to achieve it
  • Strong understanding of the pharmaceutical and biotech environment and an informed view on the evolution
  • People Leadership skills, including relevant soft skills such as listening, reflecting and people development
  • Authentic; acting with passion, honesty, respect and integrity
  • Strong communication and interaction skills
  • Innovator, Entrepreneur, Risktolerant, matrix leader, motivator, strong communicator, influencer etc
  • Proven ability to develop and build high performing teams with top talent 
  • Proven effectiveness in crisis management and transformational change initiatives
  • Strong analytical skills, with the ability to cut through and simplify complex issues

 

 


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