Clinical Development Director
Vor 3 Tagen
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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