Senior Director, Clinical Development (Respiratory Clinical Research)

Job description

Nombre del sítio: UK - London - Brentford, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence
Fecha de publicación: Jan 26 2024

A Senior Clinical Development Director is sought to provide clinical and scientific support for potential new, established and emerging indications for a late stage, acquired asset in the respiratory portfolio. As Senior Director of Clinical Development, you will work with project teams to plan and assure delivery of clinical research and development activities. You will work with early development teams to plan clinical development programs and establish efficient collaboration throughout all stages of development.

Key responsibilities in details :

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Lead the end-to-end clinical development strategy for a drug or program. Manage specific clinical development plans for product(s) and/or indication(s) in specific therapy/disease areas.

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Contribute to the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials for an asset in development. Be accountable for the clinical components of the Target Medicine Profile (TMP).

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Provide strategic leadership, for example in assuring that the clinical study designs are aligned with the IEP and CDP, and take into account the scientific rationale, regulatory requirements, product development plan and commercial goals.

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Establish and deliver to clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP

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Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.

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Serve as a clinical point of contact for senior management and senior level matrix teams.

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Contribute to the strategic and organizational initiatives in Clinical Development.

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Contribute to Business Development activities, including due diligence projects.

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Support technical and leadership development of Clinical Sciences staff via direct line management, mentoring and coaching.

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Interface with and influence a range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs that align to business strategy and address patient needs

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Lead and be accountable for the evaluation of the probability of technical success (PTS) of clinical studies/programs.

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Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients.

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Assess risk/benefit at the study and/or project level. Take action to mitigate risk where appropriate.

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Make substantial contributions to global regulatory interactions, including briefing documents, presentations, submission documents, and responses to questions.

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Champion implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions

Basic Qualifications:

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Medical Degree with specialist training or board qualification/eligibility (or having completed the comparable level of post-medical school clinical training)

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Significant (bio-)pharmaceutical industry experience in clinical drug development

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Experience with planning clinical development for an asset and/or indication. Proven record of delivery of clinical trials and projects.

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Experience of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules

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Experience of global regulatory filing/submission

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Line/matrix management experience including also coaching, mentoring and development, with a track record of inspiring and motivating high-performance team

Preferred Qualifications:

In the addition to the above, the following will be highly desirable

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Thorough understanding of respiratory diseases, underlying biology and potential therapeutic targets

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Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements

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Solid understanding of needs and priorities of regulators, payers and prescribers in relevant global market(s)

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Experience working collaboratively with multiple stakeholders on complex projects

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Track record of building and maintaining strong relationships with internal and external stakeholders

Como empresa impulsada por nuestros valores de enfoque al paciente, transparencia, respeto e integridad, sabemos que la inclusión y la diversidad son esenciales para que podamos tener éxito. Queremos que todos nuestros colegas prosperen en GSK, brindando sus experiencias únicas, asegurándonos de que se sientan bien y que sigan creciendo en sus carreras.  Como candidato para un papel, queremos que usted se sienta de la misma manera.

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