Site Name: USA – Maryland – Rockville
Posted Date: Dec 23 2019

The Head, US Technical Research & Development Strategy and Development is a member of the RDC leadership team and integrates the product and process development elements into an aligned clinical and regulatory strategy for the portfolio of programs at the RDC. This individual works with the Technical Research and Development Leader (TDL) to translate the CMC strategy into realistic, integrated project plans.

In this role YOU will lead, manages and implements strategic CMC initiatives within TRD to develop and introduce new products. It is the responsibility of the Head, TRD Programs to align CMC deliverables with RDC stakeholders (Quality, Clinical, Regulatory), TRD functions and GIO. They also support the implementation of Quality by Design to ensure right the first time focus across all development programs.

In the global TRD function framework, the head US TRD Strategy and Development has a primary accountability in connecting the global TRD community with the local RDC community, by converting and/or translating the global technical paradigm into local executable and aligned plans, in conveying local to global or global to local priorities, in easing dialogue and understanding, in resolving resource conflicts amongst programs, and in escalating risk and issues.

The role will also play an essential leadership role by fostering a TRD local community, leading local initiatives across TRD teams in order to optimize the overall TRD engagement index.

When applicable, the role will lead local strategic initiatives / projects (eg smartlab implementation, strategic infrastructure / equipment investment,…)

• Translate local RDC business objectives into global TRD strategy for projects at all development stages (Discovery, Development, and Life-cycle management) by establishing programs, defining performance targets and monitoring results.
• Represent the Global TRD organization at local RDC level, contributing to the definition of the overall RDC strategy
• Serve as key member of the TRD leadership team, core member of the Vaccine Research Board
• Serves as advisor and mentor to the Technical Develop and CMC Platform Leads
• Define and lead technical development strategy for Discovery projects in collaboration with the DPU and preclinical organizations from the respective RDC
• Support the GIO organization for technical development (e.g. manufacturing strategy of new products, technical transfer, …) and life-cycle strategies involving TRD
• Provide information to team and senior leadership conveying complex ideas and data. Foster TRD’s change agenda by generating alignment across all TRD functions and RDC stakeholders.

• Champion and drive change. Develop and implement innovative business solutions in alignment with senior management. (eg. identify opportunities and implement solutions to improve project strategies and enhance teamwork)
• Support the application of Quality by Design and PDVS Roadmap as a way of ensuring right the first time focus across all Development Programs. Foster TD’s change agenda by alignment across all functions.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree
• Industrial experience in pharmaceutical manufacturing /development
• Experience in product design, process development and major product transfer
• Experience interfacing with formulation science, analytical technologies, engineering, and packaging

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master’s degree or PhD
• Develop product strategies to deliver RDC objectives harmonizing the cross-functional efforts of TRD, Quality, Regulatory, Clinical and GIO.
• Contribute to RDC and GSK Vaccines strategy by promoting TRD LT position in various strategic meetings (e.g. RDC LT, Vaccines Research Board, project or technology specific Steering Committee,
• Exerts strong internal and external influencing to achieve established objectives and develop the skills of associates and team members.
• Lead a TRD local community, and local initiatives across teams in order to optimize the overall TRD engagement index
• Lead local strategic initiatives / projects (eg smartlab implementation, strategic infrastructure / equipment investment,…)
• Manage risks/issues having a transversal impact in the local R&D community
• Alignment on R&D local rollout of global Communication/HR related initiatives

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
• Managing individual performance.
• Creating a performance culture and driving results, prioritisation, execution, delivering performance.
• Setting strategic direction and leading on-going organisational transformation.
• Building a resilient organisation.
• Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
• Managing P&L and capital allocation.

• LI-GSK

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