Medical Director

Barrington James Limited; Lombardia; In loco; EUR 110.000 - 125.000; Tempo pieno

Descrizione del lavoro

An established industry player is on the lookout for a passionate Director of Clinical Development specializing in Neurology. This pivotal role involves leading clinical trials, shaping strategies for Neurology therapies, and collaborating with cross-functional teams to ensure successful regulatory submissions. The ideal candidate will possess a strong background in CNS conditions and demonstrate leadership in clinical development. This is a unique opportunity to drive innovation and make a significant impact in the field of Neurology, contributing to the advancement of groundbreaking therapies. If you are ready to take the next step in your career and lead transformative clinical programs, this role is for you.

Competenze

• MD with a PhD or board certification in Neurology/Psychiatry required.
• 4+ years of experience in Neurology drug development.

Mansioni

• Develop and implement clinical strategies for Neurology programs.
• Lead clinical trial design and manage budget and personnel.

Conoscenze

Clinical Development

Regulatory Compliance

Data Analysis

Project Management

Interpersonal Skills

Problem-Solving

Formazione

Medical Doctor (MD)

PhD in relevant field

Board certification in Neurology or Psychiatry

Descrizione del lavoro

Director, Clinical Development (Neurology & Psychiatry)

Job Summary:

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

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 Psychiatry
• Experience in CNS and Neurodegenerative conditions
• 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.