Director Clinical Development

The Director will provide leadership and support to Clinical Project Teams to ensure the successful design and implementation of development plans for early-stage assets. Key responsibilities include designing overall development plans, clinical trial design, execution of company-sponsored clinical trials, clinical data analysis, communication of project details, and contribution to regulatory submissions, publications, and presentations. This role will focus on the neurology and rare diseases sectors.

Responsibilities:

• Serve as a clinical/program lead in internal and external interactions, advocating for programs and ensuring their success.
• Develop and contribute to integrated clinical development plans outlining the pathway and evidence required from clinical trials for regulatory approval and market access.
• Collaborate with cross-functional teams and external advisors on the design and execution of clinical trials, incorporating innovative study designs.
• Address translational medicine needs and enable successful clinical trials through collaboration with various teams and external advisers on target engagement assay development, biomarker analysis, and natural history data analysis.
• Engage with regulatory agencies to develop novel and efficient clinical programs for rare disease populations.
• Analyze and interpret data from clinical trials and natural history studies.
• Engage stakeholders to obtain advice and feedback on development plans, trial designs, and study results.
• Communicate project information and plans to the cross-functional team and leadership.
• Manage clinical development activities during study conduct, including maintaining relationships with investigators and study teams, delivering scientific presentations, and providing training for external personnel.
• Lead or contribute to the writing and review of clinical documents for regulatory submission.
• Lead development team meetings and project reviews, setting agendas and approving actionable minutes.
• Mentor the development team and provide clinical education support for internal customers.
• Contribute to the preparation of clinical study manuscripts, posters, and presentations.

Requirements:

• PhD in biomedical science or epidemiology with 4 years of experience in the biopharmaceutical industry, preferably with direct experience in clinical science for Phase 1-3 studies.
• Proven record of designing, planning, and executing clinical studies.
• Leadership and guidance experience in project teams.
• Preferred experience in neurology, rare diseases, and/or pediatrics.
• Desirable experience in designing, planning, and executing clinical or natural history studies.
• Strong basic science background with an understanding of assay development methodologies and clinical trial enabling nonclinical studies.
• Ability to work successfully in a cross-functional environment and create strategic development plans for clinical trial assets, with a proactive and hands-on approach.
• Excellent interpersonal and communication skills, with the ability to build strong relationships with internal and external stakeholders.
• Capacity to manage multiple programs in a fast-paced, innovative environment.
• Attention to detail and quality, with the ability to make timely decisions and execute effectively.