Medical Director Lazio

Medical Director
Roma
Lazio, Lazio

Job Description 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 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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