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\nAbout the Position:\n\n\nThe Chief Medical Officer (CMO) will report to the CEO and will be a key member of Prileniaโs executive team. \n \nAs part of this role, you will be accountable for leading the clinical development of Prileniaโs products throughout the development cycle including phase 3 and product approval. You will be responsible for the clinical strategy, development plan and trial design, as well as overseeing medical affairs and safety for the company across the various programs. You will be contributing to all company and product development activities as a member of the senior management team. In this role, you will serve as a Prilenia spokesperson in external interactions with global health authorities (like FDA and EMA), at scientific meetings, and when working with collaborators. \nThis is both a strategic and an executional role that offers significant opportunities to drive the development of novel, first-in-class therapeutics for a variety of neurodegenerative disease and neurodevelopmental disorders, their positioning in the market and future market access strategy. \nThe ideal candidate has a track record of achievement in late-stage clinical development, preferably in neurodegeneration and rare diseases. Experience in ALS and Huntingtonโs Disease, as well as medical affairs experience highly preferred.\n\n\n\nRoles and Responsibilities:\n* Lead the clinical development team in designing, monitoring and executing late-stage clinical trials.\n* Lead and shape clinical strategy and Clinical Development Plans (CDPs), including scientific rationale, regulatory input and advice from medical KOLs, patient advocacy groups and payors.\n* Lead the overall development and execution of Medical Affairs strategy to ensure a robust medical engagement strategy with leading physicians, KOLs, thought leaders and key people at public health organizations. \n* Forge and bolster relationships with KOLs and investigators in the neurodegenerative space โ and bring their voices into Prileniaโs clinical programs. \n* Oversee medical monitoring and overall pharmacovigilance activities for the companyโs clinical trials and preparation for potential launch. \n* Contribute to the regulatory strategy, preparation, and review of regulatory submissions, and participate in regulatory agency meetings as relevant.\n* Contribute to the development of publication plans and present clinical data at key meetings and publish in high-level journals. \n* Prepare and present clinical development plans and clinical data for internal and external stakeholders โ executives, scientists, clinicians, potential partners and investors.\n\n\n\nQualifications:\n* MD with 10+ years of experience in Clinical Development and Medical Affairs.\n* Neurology and rare disease experience with strong preference for clinical development experience in neurodegeneration, ALS and HD. \n* A proven record of successful design, execution, close out and reporting of late stage clinical trials including guiding biostatistics design and analysis of clinical trials.\n* Proven ability to oversee other clinical and medical functions including but not limited to medical affairs, safety etc. \n* Understanding of global regulatory requirements and ability to influence decision making โ experience in late stage interactions (including successful NDAs/MAAs) with regulators preferred. \n* Record of designing and leading rigorous clinical development plans in neurodegeneration (ALS and HD preferred) and rare diseases. \n* Established links with the medical community globally and locally, with proven ability to develop close working relationships with KOLs.\n\n\n\nSkills:\n* Strong hands-on leadership skills with ability to work on both strategic and operational level of clinical and medical functions. \n* Strategic and creative thinker who can effectively design fit-for-purpose programs, processes and teams. \n* Effective communication skills, professional presence, and ability to engage effectively with stakeholders at all levels including the CEO, Board of Directors, company employees and the investor, medical and patient community.\n* Collaborative and able to motivate and energize cross functional team members to achieve shared goals.\n* โข High change agility with ability to operate effectively in ambiguous circumstances, open minded, with a can-do attitude.\n\n\n\nLocation/Time/Travel:\n* This is a full-time remote position in the East Coast US / Europe.\n* Flexible schedule with frequent calls across Israel, North America and Europe time zones.\n\n\n\n\n \n\n#Salary and compensation\n
No salary data published by company so we estimated salary based on similar jobs related to Design and Senior jobs that are similar:\n\n
$45,000 — $95,000/year\n
\n\n#Benefits\n
๐ฐ 401(k)\n\n๐ Distributed team\n\nโฐ Async\n\n๐ค Vision insurance\n\n๐ฆท Dental insurance\n\n๐ Medical insurance\n\n๐ Unlimited vacation\n\n๐ Paid time off\n\n๐ 4 day workweek\n\n๐ฐ 401k matching\n\n๐ Company retreats\n\n๐ฌ Coworking budget\n\n๐ Learning budget\n\n๐ช Free gym membership\n\n๐ง Mental wellness budget\n\n๐ฅ Home office budget\n\n๐ฅง Pay in crypto\n\n๐ฅธ Pseudonymous\n\n๐ฐ Profit sharing\n\n๐ฐ Equity compensation\n\nโฌ๏ธ No whiteboard interview\n\n๐ No monitoring system\n\n๐ซ No politics at work\n\n๐ We hire old (and young)\n\n
# How do you apply?\n\nThis job post has been closed by the poster, which means they probably have enough applicants now. Please do not apply.