Senior Director, Early Development Leader (Oncology R&D)
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham Posted Date: Sep 1 2021 Please note, this role is available in Upper Providence and Boston (US) as well as Stevenage in the UK. 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. You'll play a critical role in the development of GSK's Oncology pipeline, guiding products through the development process and making a genuine personal impact on the GSK, and wider, oncology therapy area. Additionally, through the successful deliver of this role you will build a fantastic internal and external network, and a position as an industry leading authority in Oncology R&D. 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. About You: In this position we need a talented and experienced senior leader, who will be the single point of accountability for the early development phase of an asset. You'll be a strategic thinker, able to consider both the near term scientific questions that need to be addressed to demonstrate Proof of Concept, as well as the long term, bigger picture - ensuring your decisions set up the asset for late stage development and commercial success. There is a considerable amount of matrix management involved in this role too, as you'll need to network extensively with different partners throughout R&D. This will require building partnership, influencing, managing expectations and other developed stakeholder management skills. In the end, you will deliver an asset to late stage development teams that has a well characterizes dosing and administration schedule, evidence of clinical activity and safety, and proof of concept in commercially viable tumor settings with line of sight to meaningful clinical differentiation and value for patients. Please take a copy of the Job Description, as this will not be available post closure of the advert. Why You? Required Qualifications: MD, PhD or equivalent relevant qualification 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: 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. Key Links: For more information, please visit: GSK's Oncology Transformation https://www.lifescienceleader.com/doc/building-gsk-oncology-r-d-0001 Axel Hoos Interview 2.0: https://urldefense.com/v3/__https://xconomy.com/national/2020/06/12/glaxosmithkline-keeps-oncology-2-0-growth-plans-on-track/2/__;!!AoaiBx6H!jzE3gZin5i5U6-4GipkOCaogED6cJDtNaH30f1ZPo4TTWmnNsGGVSOUYqSFDLfJS$ I-O Info https://gsk.to/2V3uyUU Why GSK? GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. 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