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Executive Director of Clinical Development

MycoMedica Life Sciences, PBC

MycoMedica Life Sciences, PBC

Shelton, WA, USA
Posted on Wednesday, April 17, 2024
  • Design, plan, and exercise medical oversight of clinical studies for all phases of development

  • Collaborate with Clinical Operations for study implementation and serve as Medical Monitor

  • Oversee interpretation and dissemination of study results, including review of clinical study reports and related publications consistent with strategy

  • Serve as a core member of the clinical development team, contribute to devising of the overall clinical strategy and ensure all activities occur in compliance with the appropriate regulations

  • Support the CEO/CMO/designee in providing medical input into the design of the clinical development program, strategic and tactical plans for investigational products in all phases of development

  • Provide oversight of clinical programs including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and MMLS’s SOPs

  • Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and MMLS’s SOPs

  • Review clinical data from all phases of development and assist in generating study reports and publications

  • Manage, coordinate, collaborate, and provide ongoing assessment, evaluation, and communication with other MMLS departments (e.g., Legal, Regulatory, Drug Safety, Finance, and Clinical Trial Ops) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished

  • Provide executive management with timely updates on progress and changes in scope, schedule, and resources as required

  • Develop and implement SOPs for clinical trials and related activities, as required

  • Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians

  • Develop and maintain professional relationships with academic and community-based study sites

  • Effectively manage communication with MMLS employees and external partners/service providers

  • M.D. preferred neuroscience (psychiatry, neurology) or strong clinical trial experience in neuroscience areas

  • Highly motivated, self-starter, and entrepreneurial thinking

  • Minimum 9 years of experience in the biotechnology/pharmaceutical industry with at least five years of hands-on clinical trials management and/or clinical development teams

  • Strong project planning, leadership, negotiation, and presentation skills, as well as an ability to contribute creative yet practical solutions to problems

  • Experience with all aspects of management of clinical trials from inception to completion across all phases of development including study design

  • Significant experience in communicating/presenting key/complex information to department/functional lead(s)/senior management

  • Strong knowledge of FDA and ICH regulations

  • Thorough knowledge of clinical medicine and clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing)

  • Expert knowledge of Good Clinical Practice (CGP)

  • Ability to multi-task and manage several projects in parallel, paying attention to detail

  • Ability to forge cross-functional working relationships with internal teams and external project partners

  • Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation of the trial and resolve the issues in a timely fashion