Senior Director Clinical Lead - Respiratory

A Senior Director Clinical Lead is sought to provide clinical and scientific support for potential new established and emerging indications for a late stage 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:

• Lead the endtoend 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.
• 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).
• Provide strategic leadership for example in assuring that the clinical study designs are aligned with the IEP and CDP and consider the scientific rationale regulatory requirements product development plan and commercial goals.
• Establish and deliver to clinical development timelines enabling key decision points and Go/No Go criteria for the CDP.
• Develop and maintain relationships with program counterparts in Commercial Research Regulatory Clinical Operations and Statistics.
• Serve as a clinical point of contact for senior management and senior level matrix teams.
• Contribute to the strategic and organizational initiatives in Clinical Development.
• Contribute to Business Development activities including due diligence projects.
• Support technical and leadership development of Clinical Sciences staff via direct line management mentoring and coaching.
• 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.
• Lead and be accountable for the evaluation of the probability of technical success (PTS) of clinical studies/programs.
• Identify and highlight transformational 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 global regulatory interactions and files including briefing documents presentations submission documents and responses to questions.
• Champion implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and produce business solutions.

Why you
Basic Qualifications:

• Bachelor of Science
• Experience in (bio)pharmaceutical industry experience in clinical drug development.
• Experience with planning clinical development for an asset and/or indication. Proven record of delivery of clinical trials and projects.
• Experience of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear datadriven decision rules.
• Experience of global regulatory filings/submission
• Line/matrix management experience including also coaching mentoring and development with a record of inspiring and motivating highperformance team.

Preferred Qualifications:

• MSc PhD PharmD or Medical Degree preferred
• If Physician specialist training or board qualification/eligibility (or having completed the comparable level of postmedical school clinical training)
• Thorough understanding of respiratory diseases underlying biology and potential therapeutic targets
• 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 global market(s)
• Experience collaborating with multiple stakeholders on complex projects.
• Record of building and maintaining strong relationships with internal and external stakeholders

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Remote Work :

No