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