Director, Clinical Development
240,000 - 340,000
United States

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.
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