Director Clinical Development

Found in: beBee S DK - 2 weeks ago

Randers, Denmark Pharmiweb Full time

Director, Clinical Development (Cardiology)

Reports To: Chief Medical Officer

Job Summary:

We are seeking a highly motivated and experienced Director of Clinical Development with a specialization in Cardiology to lead and drive our clinical development programs. The Director will play a key role in advancing our pipeline of Cardiology therapies, managing clinical trials, and contributing to the strategic development of our Cardiology portfolio.

Key Responsibilities:

Clinical Strategy: Develop and implement the clinical development strategy for our Cardiology 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 Cardiology, 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 Cardiology research and clinical trial design, ensuring that the organization remains at the forefront of the field.

Qualifications:

Medical Doctor (MD), with board certification in Cardiology or a related discipline.Proven experience in clinical development, with at least 4 years of experience in Cardiology drug development.Strong knowledge of regulatory requirements for Cardiology 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 Cardiology 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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