Executive Director, Early Development Leader

The Executive Director, Early Development Leader (EDL) is a high-responsibility, strategic role, critical for developing the vision and trajectory for a medicine that maximizes its opportunity for GSK and benefit for patients.

The EDL is the single point of accountability to lead the development of a medicine from Candidate Selection (CS) through Proof of Concept (PoC), defining the criteria necessary to identify and progress game-changing medicines through creative and innovative experimental design.

By working with various stakeholders across R&D, the EDL obtains and manages associated resources and delivers evidence in line with the strategic vision and organizational strategy to support progression beyond PoC for a clearly differentiated medicine.

Key Responsibilities:
The EDLs accountability and key responsibilities include but are not limited to:

Leadership of the Early Development Strategy

• Contributes to and establishes the development strategy to support the Medicine Profile (MP)

• Secures input and alignment from late-stage Development, Commercial, and Medical

• Ensures development strategy is kept current, as internal priorities shift and the external landscape changes

Matrix Leadership of the Early Development Team (EDT)

• Leads the multi-disciplinary Early Development matrix team and owns the performance of the EDT

• Makes clear and timely evidence-based go/no-go/accelerate decisions in line with the strategy

• Ensures excellence in execution of all governance processes

• Prioritizes activities and manages the early development plan to meet budget constraints

• Ensures team accountabilities, including study oversight, pharmacovigilance, scientific engagement, and promotional practices are in line with the development strategy and GSK expectations

• Delivers the package of evidence that supports the MP for a medicine of value

• Models GSK values and leadership expectations

Business Partnering beyond the EDT

• Provides significant input in selecting members of the EDT, in consultation with the Functional Line leaders, supporting differentiated development for team members

• Strategically partners with Functional Line Heads to ensure alignment with organizational priorities and to maximize the assets portfolio options including developing multiple indications

• Provides key support to the Project Team (PT) in the lead up to CS and to the Medicines Development Team (MDT) ahead of PoC to ensure alignment end to end on the drug development strategy

• Works closely with the Project Leader (PL) and Medicine Development Leader (MDL) to ensure smooth transitions from the PL at Candidate Selection and to the MDL upon achieving PoC

Why you?

Basic Qualifications:

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

• Advanced degree (such as PhD, MD, PhRMD, MBA)

• 10 or more years pharmaceutical drug development experience

• Pre-clinical and clinical experience in drug development with an emphasis on earlier stage clinical development and translational medicine

• Matrix leadership experience

• Experience building strategic plans and working with others within a matrix environment

Preferred Qualifications:

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

• Exhibits clinical development/end-to-end knowledge

• Demonstrates thorough translational understanding (pre-clinical/clinical)

• Experience or expertise in Immuno-Inflammation, Respiratory, Hepatology, Renal, Connective Tissue or Neurodegenerative diseases areas

• Experience as a matrix leader able to work across technical disciplines and integrate requirements from matrix partners into a coherent evidence-generation and forward plan

• Experience or clear familiarity / understanding of the attributes of early clinical development and importance of clinical pharmacology, modelling & simulation and statistics

• Experience gathering early commercial insights and awareness of the impact of external factors, e. g. , public policy, competitor landscape

• Understands the relevance of early-stage questions, including tools and methodologies for addressing the questions: "learning about the asset" and appreciates limitations and strengths of the pre-clinical setting

• Expertise/knowledge in translational medicine/experimental medicine design and management

• Strong understanding of options for regulatory pathways, Life Cycle Management and sequencing of indications

• Knowledge of manufacturing compliance and regulatory requirements

#LI-GSK

Please visit GSK US Benefits Summaryto learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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