Clinical Development Director

vor 4 Wochen

Luzern, Luzern, Schweiz Pharmiweb Vollzeit

Job Title: Clinical Development Director

Job Summary:

We are seeking a highly motivated and experienced Clinical Development Director to lead and drive our clinical development programs in Neurology. The ideal candidate will have a strong background in clinical development, with a specialization in Neurology, and excellent leadership and communication skills.

Key Responsibilities:

  • Clinical Strategy: Develop and implement the clinical development strategy for our Neurology programs, including phase I-III trials, to ensure successful regulatory submissions and commercialization.
  • Clinical Trial Design: Lead the design of clinical trials, including protocol development, selection of endpoints, and determination of appropriate patient populations.
  • Regulatory Affairs: Collaborate with regulatory affairs to ensure compliance with regulatory requirements and provide guidance on clinical trial applications and approvals.
  • Cross-functional Collaboration: Work closely with cross-functional teams, including medical affairs, clinical operations, and data management, to drive the execution of clinical trials.
  • KOL Engagement: Establish and maintain relationships with key opinion leaders in Neurology, collaborating on advisory boards and gathering expert input for study design and data interpretation.
  • Data Analysis and Interpretation: Oversee data analysis, interpretation, and preparation of clinical study reports and publications. Contribute to the development of regulatory documents.
  • Risk Management: Develop and implement risk management strategies for clinical trials, identifying potential challenges and mitigating risks to ensure trial success.
  • Budget Management: Manage the clinical development budget, including forecasting and tracking expenses for assigned projects.
  • Personnel Management: Provide leadership and mentorship to clinical development teams, including Clinical Project Managers and Clinical Research Scientists.
  • Continuous Learning: Stay up-to-date with the latest developments in Neurology research and clinical trial design, ensuring that the organization remains at the forefront of the field.

Qualifications:

  • Medical Doctor (MD) with PhD in a relevant field or board certification in Neurology or a related discipline.
  • Experience in CNS and Neurodegenerative diseases.
  • Proven experience in clinical development, with at least 4 years of experience in Neurology drug development.
  • Strong knowledge of regulatory requirements for Neurology clinical trials and drug development (FDA, EMA, etc.).
  • Demonstrated experience in leading cross-functional teams and managing clinical development projects.
  • Excellent interpersonal and communication skills, with the ability to build and maintain relationships with external partners, investigators, and KOLs.
  • Strong analytical and problem-solving skills, with the ability to interpret complex clinical data.
  • Proficiency in project management, including budget management and resource allocation.
  • A track record of successful regulatory submissions and approvals in the Neurology field is highly desirable.
  • An entrepreneurial mindset with a strong drive for innovation and the ability to adapt to a rapidly changing clinical development landscape.

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