This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

• Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development
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• Ensuring alignment with and support to project strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP
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• Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe
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• Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
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• Developing and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
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• Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development
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• Supporting technical and leadership development of Clinical Sciences staff via mentoring and coaching for matrix team members
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• Actively contributing or leading the end-to-end clinical development strategy for a drug or program. Manages specific clinical development plans for product(s) and/or indication(s) in assigned therapy disease area
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• Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development
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• Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs and align to business strategy and address patient needs
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• Gathering and supporting the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile.
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• Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches
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• Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses
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• Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery

Why you?

Basic Qualifications:

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

• Medical degree
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• Experience in IBD clinical drug development with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options
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• Clinical training and/or applicable clinical research experience; experience with clinical development planning and running clinical trial from concept study idea to publication.
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• Experience with ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area
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• Experience using digital tools to create innovation
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• Experience with clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
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• Experience integrating genetic data to inform and guide clinical protocols
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• Experience utilizing statistics and visualization techniques to interpret or analyse complex information and make correct inferences and conclusions

Preferred Qualifications:

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

• Experience leading line or matrix teams with a strong reputation of inspiring and motivating high performance
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• Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s)