​Director, Clinical Development – Neurology

​Key Responsibilities:

1. Strategic Leadership in Clinical Development:

• Serve as a clinical lead, guiding internal and external project teams to ensure the success of clinical programs.

• Develop and contribute to comprehensive clinical development plans, outlining the necessary data and evidence from trials to gain regulatory approval and market access.

• Oversee the design and execution of clinical studies, collaborating with cross-functional teams and external advisors to implement innovative trial designs.

2. Clinical Trial Oversight:

• Lead the planning and execution of clinical trials, ensuring trials are well-designed, efficient, and compliant with regulatory standards.

• Develop strategies to address translational medicine needs, including the identification and analysis of biomarkers and natural history data to optimize trial outcomes.

• Collaborate with regulatory bodies and the internal regulatory affairs team to create streamlined and effective development plans for neurology and rare disease populations.

3. Data Analysis and Communication:

• Analyze and interpret clinical trial and natural history study data, providing insights to guide ongoing and future development.

• Communicate clinical program progress and findings to internal teams, leadership, and external stakeholders, including key opinion leaders and advocacy organizations.

• Lead or contribute to the writing and review of regulatory submissions, scientific presentations, and publications.

4. Cross-functional Collaboration and Leadership:

• Work closely with internal teams across multiple functions to ensure the seamless progression of clinical development activities.

• Build and maintain relationships with clinical investigators, study teams, and external partners to facilitate trial conduct and ensure successful study execution.

• Lead action-oriented meetings, manage risks, and mentor team members, providing clinical education and support where needed.

5. Scientific Expertise:

• Stay informed of the latest advancements in the neurology field, attending relevant scientific and technical conferences and maintaining up-to-date knowledge of therapeutic developments.

• Contribute to scientific publications, posters, and presentations to share findings from clinical studies.

Qualifications:

• PhD in a relevant biomedical science or epidemiology field with a minimum of 4 years of experience in the biopharmaceutical industry, specifically in clinical development.

• Proven track record in the design, planning, and execution of Phase 1-3 clinical studies.

• Experience in neurology, rare diseases, and/or pediatric populations is highly desirable.

• Strong background in scientific research, with experience in assay development and clinical trial-enabling nonclinical studies.

• Demonstrated ability to lead project teams in a cross-functional, fast-paced environment, with the skills to develop strategic clinical plans and operationalize them effectively.

• Exceptional communication and interpersonal skills, with the ability to foster relationships with both internal and external stakeholders.

• Strong attention to detail, with the ability to manage multiple projects simultaneously and make timely, informed decisions.

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