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Clinical Development Director

2 months ago


Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
About the Role

We are seeking a highly skilled Clinical Development Director to lead our efforts in the respiratory therapeutic area. As a key member of our team, you will be responsible for driving the clinical development of novel assets to treat pulmonary diseases.

Key Responsibilities
  • Contribute to the development of clinical development plans (CDPs) for emerging respiratory indications.
  • Lead cross-functional teams to ensure alignment with CDPs towards market authorization.
  • Develop and maintain relationships with stakeholders in Research and Early Development, Regulatory, Clinical Operations, and Statistics.
  • Contribute to the implementation and embedding of strategic initiatives and organizational initiatives in Clinical Development.
  • Develop and lead the end-to-end clinical development strategy for a drug or program.
  • Manage specific clinical development plans for products and/or indications in assigned therapy disease area.
  • Serve as a clinical point of contact for senior management and senior-level matrix teams, both internally and externally.
  • Interface with external experts, including regulators, payors, CROs, disease area experts, and clinical study investigators.
  • Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients.
  • Contribute to regulatory interactions, including briefing documents, presentations, and addressing questions and responses.
  • Provide effective support and oversight of evidence generation activities to ensure patient safety and study delivery.
Requirements
  • MD and/or MD/PhD with board certification (or equivalent) in Pulmonary Medicine, Internal Medicine, or Critical Care Medicine.
  • Experience in advanced data analytics in clinical research/development.
  • Experience utilizing statistics and visualization techniques to interpret or analyze complex information to facilitate decision-making.
Preferred Qualifications
  • Experience leading line or matrix teams with a strong reputation for inspiring and motivating high performance.
  • Experience with data visualization and analytics software.
  • Solid understanding of respiratory clinical drug development, including disease biology and potential therapeutic targets.
  • Significant clinical training and/or applicable clinical research and development experience.
  • Robust knowledge of ICH guidelines, FDA requirements, and regulatory and reimbursement data requirements.
  • Demonstrated experience integrating genetic data to inform and guide clinical protocols.