Early Development Leader, Oncology R&D

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.
Find out more:
Our approach to R&D

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.

Please note: This position requires an on-site office -based presence 2 to 3 days a week in the Waltham- MA.; UK (London or Stevenage); Upper Providence- PA.; Switzerland (Zug); or Poland (Warsaw).

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

In this role you will:

Key Responsibilities:

• 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.

Why you?

Basic Qualifications:

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

• Bachelor's Degree
• Experience in oncology clinical development
• Experience of early-stage oncology and it's connections with late-stage development
• Experience of translation of pre-clinical data to develop an oncology clinical development program
• Experience managing and developing individuals and teams to perform to their best strengths
• Experience of preclinical medicine development needs, translational medicine, including experimental medicine design and its appropriate application
• Experience 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:

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

• 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 activities
• Experience leading or participating in late stage (Phase 3) clinical development program
• Experience leading or participating in commercial product launch activities.

Please visit GSK US Benefits Summary to 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, it's 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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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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