The Therapeutic Area (TA) Strategic Lead will lead the strategic planning within a given TA and support the TA Head in the following areas:
• Provide strategic input to TA portfolio management and prioritization
• Serve as the key partner and contributor for the TA to strategic planning, drug discovery, early and translational development; and prepare TA-specific strategic plans and TA based strategic initiatives.
• Closely collaborate with the Program Lead Physicians and Scientists in the development of new strategic options for assets in late development.
• Serve as the responsible GCR&D representative for compounds in early-stage development from internal Celgene programs and from corporate partnerships (Early-Stage TA).
• Be responsible for evaluating, and doing diligence on, external business development opportunities within the TA as well as proactively and continuously identify unmet medical need, gaps and development opportunities in the TA
• Provide medical and scientific expertise and consultation to internal stakeholders including the following: Business Development, Early Development, Translational Development, Medical Affairs, Marketing and Regulatory Affairs.
• Actively interact and maintain effective relationships with external stakeholders including: Key Opinion Leaders (KOLs), Principal Investigators, Partner companies, Regulatory Agencies and other related experts.
• Develop strategy through collaboration with internal stakeholders (Program Lead CRPs and CRS as well as functional areas like DST, GPT, G3M) and external stakeholders and ensure alignment of strategy across the TA with the overall corporate strategy.
• Development of Therapeutic Area Strategy: In collaboration with the TA Head and the Program Lead CRPs and CRS develop the GCR&D Therapeutic Area strategy as input to the strategic plans of DST.
• Clinical Product Development Plans (CDP): Consult on CDPs for assets with programs in late development including on aspects of disease strategy beyond a single asset. Contribute for GCR&D to CDPs in early development.
• Integration of development from Early Development into GCR&D: Work closely with Early Development to ensure alignment on strategy and late-stage registration pathways as determined by CRD
• External Communication and Intelligence Gathering and Assessment: Represent Celgene to external investigators and thought leaders in TA. Review, integrate and communicate to CRD important external data in the relevant TA and from presentations and publications
• Provide peer review on Protocol Concept Sheets and Protocols across Hem/Onc TAs.
• Provide internal training and mentoring
• Publications and Presentations: Advise clinical R&D scientific communication plans and strategy, write and/ or edit manuscripts and presentations, ensure coordination with other internal and external stakeholders.
• Interaction Matrix: Will serve as key partner for the TA in Early Development study review, translational development, Thematic Centers of Excellence in Early Development, and Business Development. Will be an ad hoc attendant of the global project teams and will collaborate with Program Lead CRPs to advance strategic planning for the assets of the resp. program.
• Will serve as deputy to the TA head for the Disease Strategy Teams and prepares TA input to the DST.
• Leadership: Provide leadership and guidance in TA to Clinical Research Physicians and Clinical Research Scientists.
MD and/or PhD with documented experience in translational and/or clinical scientific research preferably with clinical training in Hematology/Oncology. Ideally 8+ years experience in early and/or late stages of Clinical Development and in conducting clinical trials and translational research.
• M.D. and/or PhD (or equivalent) with relevant translational scientific and/or clinical research experience (optimally laboratory research experience in hematology-oncology, immunology, and/or molecular biology)
• A minimum of seven years of experience in early/late phases of clinical trials is required.
• A minimum of 8 years of experience in clinical medicine and specialized clinical training in hematology and oncology is optimal (non-physicians should have demonstrable experience and understanding of clinical medicine in hematology-oncology)
• Knowledge of the respective disease area is highly desirable
• Prior training and background to effectively serve as a medical monitor and prepare NDA/MAA clinical documents is required. Experience and demonstrated ability to perform the above activities is preferred.
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