Group Senior Director, Respiratory Clinical Development
A Group Senior Director, Respiratory Clinical Development is sought to provide clinical and scientific support for potentially additional and established indications for the IL5 portfolio and emerging indications for other early and late-stage assets in the Respiratory portfolio. As Group Senior Clinical Development Director, you will lead important new initiatives in the aIL-5 biologic space. You will work with project teams to plan and assure delivery of clinical research and development activities. You will work late development teams to plan clinical development programs and facilitate close collaboration between Research and Development. You will have direct line management responsibilities and will also lead senior clinicians and clinical scientists in a matrix role.
Job purpose and key responsibilities:
Lead matrix team of senior clinicians and clinical scientists with responsibilities for various clinical development programs. Support technical and leadership development of Clinical Sciences staff via direct line management, mentoring and coaching.
Identify and highlight acceleration, innovation, and transformational opportunities where projects can offer highly significant benefit to patients.
Champion implementation of innovative methods and processes within clinical development and gain stakeholder support; encourage others to think differently and come up with business solutions. Oversee the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials for those assets in development under your leadership. Provide strategic leadership in designing the CDPs and IEPs, and then, for example in assuring that clinical study protocol designs are aligned with the IEP and CDP, and consider the scientific rationale, regulatory requirements, product development plan and commercial goals.
Develop and maintain relationships with corporate counterparts in Commercial, Early Development, Research, Regulatory Affairs, Clinical Operations, Biostatistics, and other groups.
Oversee clinical aspects of Business Development activities, including due diligence projects.
Serve as a clinical point of contact for senior management and senior level matrix teams.
Interface with and influence a range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) to deliver clinical programs that align to business strategy and address patient needs
Identify and highlight acceleration and value-finding opportunities where projects can offer highly significant benefit to patients.
Assess risk/benefit at the study and/or project level. Take action to mitigate risk where appropriate.
Make substantial contributions to regulatory interactions, including briefing documents, presentations, submission documents, and responses to questions.
MD or PhD or PharmD degree
Significant industry experience in clinical drug development, including leading preparation of submission documents to regulatory authorities for approval of a new drug or indication, preferably in Respiratory, Immunology, or Infectious Disease.
Experience with leading and driving clinical development for an asset and/or indication. Proven record of delivery of clinical trials and projects. Knowledge of clinical research methodology and principles of biostatistics to facilitate accelerated. innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules
Line management, coaching, mentoring and development experience. Experience leading line and matrix teams with a track record of inspiring and motivating high performance
Strong leadership skills, with proven ability to inspire high performance from cross-functional teams
Track record of building and maintaining strong relationships with internal and external stakeholders
Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements
Solid understanding of needs and priorities of regulators, payers, and prescribers in relevant market(s)
Post-graduate qualification valuableWhy GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.
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