Early Development Leader, Oncology R&D
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
The Early Development Leader (EDL) is a critical role within GSK R&D Oncology which reports to the VP EDLs. The EDL is the single point of accountability to strategically lead the development of a medicine between Lead Optimization (LO) through Proof of Concept, substantially contributing to defining the early development strategy for an asset. By working with various stakeholders across R&D, Commercial and Manufacturing, they obtain and manage associated resources and deliver evidence in line with the strategic vision and organizational strategy to support progression beyond early development for a clearly differentiated medicine.
This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following :
- Strategic leadership and single point of accountability for the development of an asset or portfolio of assets within R&D, from Lead Optimization through Proof of Concept.
- Contributing to and establishing the development strategy aligned with Medicine Profile (MP) with input and alignment from late-stage development, franchise commercial, and medical.
- Makes clear evidence-based go / no go / accelerate decisions, based on whether the results fulfil the strategy set out for the medicine, and identify clear inflection points.
- Identifies and engages the external community appropriately in robust scientific dialogue that generates insight and advances scientific and medical understanding.
- Ensures timely and appropriate interaction and exchange of information between GSK and external communities (e.g., patients, physicians, payers, regulators), in strict adherence with GSK Policies, and GSK Global Scientific Engagement Principles and Standards.
- Ensures balanced and robust scientific communications in all formats.
- Proactively identifies unique regulatory requirements that are necessary for the development of early-stage development e.g. introduction of first dosing in patient populations, clinical pharmacology and metabolism.
- Anticipates the changing healthcare & competitive environment and delivers innovative strategies and plans to generate evidence for relevant pharmacology / efficacy and prescribing / usage within this environment.
- Understands the impact of new data on the value / positioning of products in guidelines / formularies.
- When necessary, in early stage, partners with Business Development to facilitate diligence reviews, product positioning and / or alternative business strategies (e.g., public private partnerships, co-development) and internal review and decision-making processes in line with GSK governance procedures as well as use of appropriate alliance management mechanisms to ensure successful business transactions and relationships.
- Models GSK values and leadership expectations.
Basic Qualifications :
Bachelor's DegreeExperience in oncology clinical developmentExperience of early-stage oncology and its connections with late-stage developmentExperience of translation of pre-clinical data to develop an oncology clinical development programExperience managing and developing individuals and teams to perform to their best strengthsExperience of preclinical medicine development needs, translational medicine, including experimental medicine design and its appropriate applicationExperience of clinical development which includes end to end familiarity and accountability for all aspects of the strategic planning through to PoC which enables progression beyond PoC.Preferred Qualifications :
Three (3) or more years' experience leading oncology development programs with experience fulfilling requirements of regulatory filings to initiate clinical testing (e.g. IND).Experience leading or participating in Business Development / Due Diligence activitiesExperience leading or participating in late stage (Phase 3) clinical development programExperience leading or participating in commercial product launch activities.GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas : respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.