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Platform Development Lead

Location: 

Anderlecht, Brussels, Belgium

Job Function:  Clinical Development
Job ID:  64272

Help us transform patients’ lives.

At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

To strengthen our Rozimab Mission team, we are looking to fill the position of:

 

Global Platform Development Lead, Rozanolixizumab

 

The Global Development Lead for Rozimab plans, directs and is accountable for innovative and competitive late phase clinical programs in the specific rare disease area/patient populations being targeted with our therapy.  This candidate is expected to have global visibility of the rare disease clinical environment, to have had global accountability previously, to have extensive experience interacting with health authorities (e.g FDA, EMA, PMDA, & COMP), and to have experience in the development and approval of medicines for rare diseases.

In close collaboration with the Rozimab Mission Lead, the Global Rozimab Development Leader is accountable for leading the matrix development team within the Mission to ensure the global development plan is appropriately designed, internally aligned, risk managed, optimized, and implemented, including:

-             Alignment with TPP and thereby delivers a patient focused, clinically meaningful differentiated medicine by ensuring appropriate Evidence Plans are developed, reviewed, approved and implemented

-             Seeks new, innovative opportunities for differentiation, acceleration, cost reduction and /or access augmentation in alignment with UCB’s Development Practice

-             Is in line with UCB Strategic Plan to optimize patient value (i.e. focused on sub-populations and clinical differentiation)

-             Scenario planning based on understanding of key risks and sensitivities

-             Designed for optimal use of patient subjects – from both a clinical, regulatory and access perspective – for the benefit of differentiated science to solution creation 

 

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 Global Rozimab Development Leader will assemble a cross-functional Development Leadership Team responsible for oversight of the full asset’s development. This will include leadership of matrixed colleagues from the Mission, NewMeds and the Practices. Pre-PoC indications for Rozimab will be developed by NewMeds under the governance of the Early Development Board, with strategic input from the Development Leadership Team. The Global Rozimab Development Leader will be the single source of accountability for all post-PoC elements of the development program.

 

MAJOR ACCOUNTABILITIES

•             Accountable for leading the matrix Development sub-team within the Mission and for design and implementation of the development/evidence plan that will deliver in line with the requirements of the TPP. To deliver the overall solution plan in line with agreed timing and the budget

 

•             Working in partnership with Mission Lead, will ensure that pre-transition scenarios are developed (in line with TPP) to support clear go-/no-go decision at POC and at decision points thereafter through timely implementation of confirmatory development plan.  Deliverables to support transition include:

o            Base case upside and downside development scenarios

o            Initial CDP to include critical success factors for progression at subsequent milestones and oversight of production of other Evidence Plans and Integrated Evidence Plan

o            Regulatory strategy, scenarios and HA / payer interaction and negotiation plans

o            Sensitivity analysis (Risk/Time/Cost) for the ability to deliver the TPP in a timely cost efficient manner that provides patient value, examining subpopulations as appropriate

o            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 UCB’s Development principles and drivers, that delivers a differentiated TPP 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

 

EXPERIENCE

Min of 10 years Drug Development experience as a pharma professional (such as project leadership, regulatory, clinical operations, clinical study physician, CPD) in different environments and been shown to deliver results

Proven track record in drug development, regulatory interactions, successful matrix leadership and demonstration of core attributes as above

Specific skills/competences 

-             proved drug development experience in leadership role

-             US healthcare ecosystem knowledge and experience

-             Strong project delivery mindset and project management understanding

-             Strong understanding of the pharmaceutical and biotech environment and an informed view on the evolution

-             Strong communication and interaction skills

 


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