Early Development Leader

Role Summary

The 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 initiation of Lead Optimization 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.

Responsibilities

• 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 asset 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 accelerate/go/no-go 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 asset‚Äôs portfolio options including developing multiple indications
• Provides key support to the Project Team (PT) in the lead up to the Commit to Lead Optimization milestone and to the Medicines Development Team (MDT) following achievement of PoC to ensure end-to-end alignment on the drug development strategy
• Works closely with the Project Leader (PL) and Medicine Development Leader (MDL) to ensure smooth transitions from the PL ahead of Commit to Lead Optimization and to the MDL upon achieving PoC

Qualifications

• Advanced degree such as PhD, MD, PharmD, MBA or equivalent is required
• Minimum of 10 years drug development experience in the pharmaceutical industry - Must demonstrate deep drug development expertise
• Proven ability to think and plan strategically and to work with members of other functions within a matrix environment utilizing well-developed leadership and stakeholder management skills
• Understands the relevance of early-stage questions, including tools and methodologies for addressing the questions: ‚Äúlearning about the asset‚Äù and appreciates limitations and strengths of the pre-clinical setting
• Demonstrates thorough translational understanding (pre-clinical/clinical)
• Pre-clinical and clinical development experience (end-to-end knowledge)

Skills

• Experience or expertise in Immuno-Inflammation, Respiratory, Hepatology, GI, 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
• Prior significant pre-clinical and clinical expertise in drug development with an emphasis on earlier stage clinical development and translational medicine
• 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

Education

• Advanced degree as listed in Qualifications (e.g., PhD, MD, PharmD, MBA)