About us
Headquartered in Shelton, WA MycoMedica is a clinical-stage biotech company. Our mission is to provide better treatment solutions for patients with neuropsychiatric disorders. We hold ourselves to the highest standards of integrity and scientific rigor as we investigate new treatment options using fungi-based solutions. Our trials are designed to evaluate the safety of low doses of psilocybin, utilizing a novel dosing paradigm to optimize pharmacology while maximizing access and reducing the burden for patients and providers. Our first candidate is for the treatment of pre-menstrual dysphoric disorder (PMDD).
About the Role
The Executive Director is responsible for oversight of Clinical Development. The position designation will be determined by the candidate's skill and experience and entails the following responsibilities.
Responsibilities
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