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Early Mission Development Lead

Location: 

Anderlecht, Brussels, Belgium

Job Function:  Research & Early Development
Job ID:  65695

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 Early Mission Development Lead will lead the mission in full co-leadership with the Early Mission Commercial Lead and is accountable for leading early development projects from candidate selection (DP3) through to progression of the project to late phase, termination or out licensing (on a case by case base.  The Development Lead may lead the project until to MAA/NDA approval). 

 

  • Ensuring a seamless global integrated evidence plan is appropriately designed from early stages to submission and beyond to launch and life cycle management (LCM), internally aligned, risk managed, optimized, implemented and timely delivered, ensuring; alignment with target patient value proposition (TPVP) and thereby delivers a patient focused, clinically meaningful differentiated medicine by ensuring appropriate Evidence Plans are developed, reviewed, approved and implemented from earliest stages.  Aligned with UCB Strategic Plan to optimize the patient value (i.e. focused on sub-populations and clinical differentiation, through application of New Development Paradigm as above).  Scenario planning based on understanding of key risks and sensitivities.  Designed for optimal use of patient subjects – from both a clinical, regulatory, access, competitive intelligence (CI) and early Evidence Evidence (Real World Evidence, Patient engagement) perspective – for the benefit of a differentiated science to solution creation.
  • Driving Innovation and promoting SMART Risk Taking
  • Monitoring and evaluates external ecosystem for advances in drug development approaches and applies as appropriate.

 

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.

 

The position can be location in either Slough, UK or Anderlecht, Belgium.

 

Primary responsibilities

Accountable for leading the matrix development team and for design and implementation of the integrated evidence plan that will deliver in line with the requirements of the TPVP and in line with agreed timing and budget.

  • Developing together with the commercial co-lead a 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
  • Translating the science into the clinic by designing robust development plans for early phase Ph1-2/PoC(s)
  • Designing late development plans for Ph3/Ph3b in sync with agreed regulatory and access strategy and aligned with late development needs; 
  • Translational and biomarker development as needed
  • Budget & resource requirement and management 
  • Go/No go decision tree

 

Working in partnership with Commercial Co-Lead, will ensure that pre-transition scenarios are developed (in line with TPVP) to support clear go-/no-go decision at end of Ph2/POC and at decision points thereafter through timely implementation of confirmatory development plan.  Deliverables to support transition include: base case upside and downside development scenarios, including application of new development paradigm (NDP) value drivers where appropriate with an understanding of their sensitivities.  Initial clinical development plan (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
  • Ongoing team development and business context setting for optimal team empowerment
  • Planning and inclusion (at risk when needed) of other (eg CMC, Non-clinical) activities etc
  • Continual improvement of communication practices 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 experience

Considerable expereince in Drug Development as a pharma professional (such as project leadership, regulatory, clinical and/or technical operations, clinical development physician, CPD) in different environments and been shown to deliver results.  Proven track record in regulatory interactions, successful matrix leadership and demonstration of core attributes as above.

  • Strategic Mindset
  • Strong project leadership and 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
  • Innovator, entrepreneur, risk-tolerant, 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
  • Fosters a culture and mindset of learning from successes and failures
  • Creates an agile and open environment across multiple functions to encourage intellectual curiosity and innovation

 


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