Senior Director, Clinical Development

US \ EU

Reporting to the CSO and Head of Early Clinical Development, this role will serve as a medical expert across Prilenia’s clinical programs in various neurology indications. This role will contribute medical and clinical trial expertise into the development programs, prepare clinical trial and regulatory documents and build strong relationships with key opinion leaders. This position will collaborate closely with other functional groups including Clinical Operations, Regulatory Affairs, CMC and Research.

Required Qualifications:

  • At least 7 years clinical development experience in neurology in biotech/pharma, preferably in Neurodegeneration.

  • Advanced degree (e.g., MD, Ph.D., PharmD) or equivalent experience

  • Proven record of successful design, execution, closeout, and reporting of Phase 2 and/or 3 clinical trials.

  • Demonstrated strategic and critical thinker, with success in designing clinical trials that have supported regulatory filings.

  • Established links with the medical community globally and locally, with proven ability to develop close working relationships with KOLs.

  • Outstanding communication skills, professional presence, and ability to engage effectively with stakeholders at all levels.

  • Hands-on expert who likes to roll up his/her sleeves including writing and research.

  • Collaborative and able to motivate and energize cross functional team members to achieve goals together.

  • High change agility with the ability to operate effectively in ambiguous circumstances, open minded, with a can-do attitude.

  • Excellent project management skills: self-motivated and can prioritize multiple tasks and goals to ensure the timely, on-target accomplishment of deliverables.

Roles and Responsibilities:

  • Develop clinical development strategy and Clinical Development Plans (CDPs), including scientific rationale, implementing regulatory input and advice from medical and patient advocacy groups.

  • Design high quality clinical trial protocols with a patient-centric focus, which are aligned with the CDP and product strategy. Seek and collaborate on CDPs and protocols with internal and external stakeholders including Regulatory, Clinical Operations, Commercial, and Research.

  • Provide oversight of clinical studies, protocol implementation, medical data review, results interpretation, and reporting.

  • Help build and manage relationships with investigators to support execution of studies, patient recruitment.

  • Contribute to regulatory strategy, preparation and review of regulatory submissions.

  • Contribute to the development of medical and clinical publication plans and present clinical data at key meetings.

  • Develop and maintain relationships with investigators, pharmaceutical partners/sponsors and KOLs.
     

Location/Time/travel:

  • This is a full-time position in the Netherlands or East Coast US

  • Flexible schedule with frequent calls across Israel, North America and Europe time zones

If you wish to apply for this position, please email your CV to