Note: The job is a remote job and is open to candidates in USA. Meet Life Sciences is partnering with an established biotechnology company to hire a Director, Clinical Development for its Late-Stage Development organization. The role provides scientific leadership and clinical oversight for a global Phase III atopic dermatitis program, partnering cross-functionally to support study execution, regulatory interactions, clinical documentation, and future NDA/BLA submissions.
Responsibilities
- Take a lead clinical/scientific role on a global Phase III study in atopic dermatitis, supporting the program through pivotal development and toward NDA/BLA submission
- Lead the scientific design and clinical oversight of global Phase III trials, ensuring alignment with the broader Target Product Profile and development strategy
- Serve as a primary Clinical Development representative on the Global Study Team
- Partner closely with Clinical Operations, Regulatory Affairs, Biostatistics and other functions to drive study execution and key program milestones
- Lead ongoing clinical data review, interpretation and signal detection, translating emerging findings into recommendations for senior Clinical Development leadership
- Provide clinical and scientific guidance around protocol interpretation, study conduct and site/investigator questions
- Support interactions with global health authorities and contribute to responses to regulatory questions
- Contribute to protocols, Investigator Brochures, Clinical Study Reports, scientific presentations, publications and other key clinical documents
- Engage with investigators, KOLs and study sites to support successful execution of the global development program
- Contribute directly to the clinical documentation and activities required to support future NDA/BLA submissions
Skills
- Approximately 8–10+ years of research and/or clinical development experience
- Meaningful experience within late-stage clinical development
- Experience supporting at least one global Phase III study through start-up and/or database lock
- Strong clinical data review, interpretation and scientific communication capabilities
- Experience developing and reviewing protocols, Investigator Brochures, study manuals, regulatory responses and other clinical documents
- Ability to provide leadership and influence within a matrix environment without necessarily having direct-line authority
- PhD, PharmD or equivalent scientific doctorate preferred; exceptional candidates with equivalent industry experience will also be considered
- Experience within Immunology & Inflammation is highly desirable, with direct experience in atopic dermatitis particularly relevant
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