Early Development Leader (Oncology R & D), Open to flexible working
Are you keen to contribute to defining the early development strategy for an asset and are energized by a global scientific environment that leverages cutting edge technology to help shape the future of oncology medicines? If so, this Early Development Leader role could be an exciting opportunity to explore.
About GSK Oncology:
GSK Oncology R&D is focused on building industry-leading portfolios in four cutting-edge areas of science:
- Immuno-Oncology : using the human immune system to treat cancer
- Cell/Gene Therapy: engineering human T-cells to target cancer
- Cancer Epigenetics: modulating the gene-regulatory system of the epigenome to exert anti-cancer effects
- Synthetic Lethality: targeting two mechanisms at the same time which together, but not alone, have substantial effects against cancer
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 Candidate Selection (CS) and 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.
An Oncology EDL is a talented and experienced senior leader with a proven ability to think and plan strategically, to work with members of other functions within a matrix environment and should have well developed leadership and stakeholder management skills. Oncology EDL's accountability and key responsibilities include but are not limited to:
- Strategic leadership and single point of accountability for the development of an asset or portfolio of assets within R&D, from candidate selection 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.
- MD, PhD or equivalent
- Understanding of oncology clinical development practices
- Understands relevance of early stage questions in oncology and their implications on late stage development.
- In depth understanding of translation of pre-clinical data to develop an oncology clinical development program.
- Proven ability to think and plan strategically, to work with members of other functions within a matrix environment and well-developed leadership and stakeholder management skills.
- Track record of developing individuals and teams to perform to their best strengths
- In-depth knowledge/understanding of preclinical medicine development needs, translational medicine, including experimental medicine design and its appropriate application, as well as knowledge and 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.
- Three (3) or more years 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 programs
- Experience leading or participating in commercial product launch activities. *LI-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, rigor and risk, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritization, execution, delivering performance.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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