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Chief Medical Officer

Prilenia

Prilenia

United States
Posted on Friday, January 5, 2024
About the Position:
The Chief Medical Officer (CMO) will report to the CEO and will be a key member of Prilenia’s executive team.
As part of this role, you will be accountable for leading the clinical development of Prilenia’s 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.
This 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.
The ideal candidate has a track record of achievement in late-stage clinical development, preferably in neurodegeneration and rare diseases. Experience in ALS and Huntington’s Disease, as well as medical affairs experience highly preferred.

Roles and Responsibilities:

  • Lead the clinical development team in designing, monitoring and executing late-stage clinical trials.
  • 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.
  • 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.
  • Forge and bolster relationships with KOLs and investigators in the neurodegenerative space – and bring their voices into Prilenia’s clinical programs.
  • Oversee medical monitoring and overall pharmacovigilance activities for the company’s clinical trials and preparation for potential launch.
  • Contribute to the regulatory strategy, preparation, and review of regulatory submissions, and participate in regulatory agency meetings as relevant.
  • Contribute to the development of publication plans and present clinical data at key meetings and publish in high-level journals.
  • Prepare and present clinical development plans and clinical data for internal and external stakeholders – executives, scientists, clinicians, potential partners and investors.

Qualifications:

  • MD with 10+ years of experience in Clinical Development and Medical Affairs.
  • Neurology and rare disease experience with strong preference for clinical development experience in neurodegeneration, ALS and HD.
  • 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.
  • Proven ability to oversee other clinical and medical functions including but not limited to medical affairs, safety etc.
  • Understanding of global regulatory requirements and ability to influence decision making – experience in late stage interactions (including successful NDAs/MAAs) with regulators preferred.
  • Record of designing and leading rigorous clinical development plans in neurodegeneration (ALS and HD preferred) and rare diseases.
  • Established links with the medical community globally and locally, with proven ability to develop close working relationships with KOLs.

Skills:

  • Strong hands-on leadership skills with ability to work on both strategic and operational level of clinical and medical functions.
  • Strategic and creative thinker who can effectively design fit-for-purpose programs, processes and teams.
  • 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.
  • Collaborative and able to motivate and energize cross functional team members to achieve shared goals.
  • • High change agility with ability to operate effectively in ambiguous circumstances, open minded, with a can-do attitude.

Location/Time/Travel:

  • This is a full-time remote position in the East Coast US / Europe.
  • Flexible schedule with frequent calls across Israel, North America and Europe time zones.