Global Clinical Trial Leader

Vor 3 Tagen

Basel, Schweiz Noema Pharma Vollzeit

Noema Pharma is a clinical-stage biotech company targeting debilitating central nervous system (CNS) disorders characterized by imbalanced neuronal networks.

At Noema Pharma, every patient matters.

Our pipeline contains novel therapies designed to address debilitating CNS disorders in order to improve quality of life and patient outcomes.

We partner with patients, their families and caregivers, and healthcare professionals to provide a comprehensive approach that goes beyond treating symptoms to ensure that patients’ experiences, perspectives, needs, and priorities are meaningfully incorporated into our work.

You will be a member of a cross-functional Clinical Trial Team, driving cross-functional interfaces and providing direction and guidance to the team for successful trial execution.

Tasks
  • Lead the planning, execution, and management of global clinical trials in neuroscience from initiation to completion.
  • Collaborate with cross-functional teams, including clinical operations, clinical development, regulatory affairs, and data management, to ensure the successful implementation of clinical trial protocols.
  • Develop and oversee clinical trial budgets, timelines, and resource allocations, ensuring adherence to quality standards and regulatory requirements.
  • Interface with key stakeholders, including CROs, investigators, key opinion leaders, and study sites, fostering strong relationships and effective communication.
  • Monitor trial progress, review data quality, identify and address potential issues, and implement corrective actions as necessary.
  • Stay current with industry trends, regulatory guidelines, and scientific advancements in oncology, incorporating relevant knowledge into trial strategies.
  • Contribute to the development of clinical development plans and study protocols. Ensures clinical trial is inspection-ready at all time and Trial Master File (TMF) completion including TMF plan is in place and ongoing QC activities are performed to always ensure TMF completeness.
  • Contributes to process improvements or acts as Subject Matter Expert for SOP development/update or training.
  • Coaches new clinical trial colleagues during their onboarding as assigned.
Requirements
  • Advanced degree in a relevant scientific discipline (PhD MS, MPH or equivalent).
  • At least 7 years of experience in clinical trial management in neuroscience including project management
  • Proven track record of successfully leading global clinical trials from inception to completion, mainly in Phase II & Phase III.
  • In-depth knowledge of GCP, ICH guidelines, EU CTR, US FDA CFR, and other relevan tregulatory requirements.
  • Experience with health authority inspections (FDA/EMA) and audits preferred.
  • Strong leadership and communication skills, with the ability to collaborate effectively across diverse teams and cultures.
  • Exceptional organizational and problem-solving abilities.
    Proficiency in project management tools and systems.
  • Demonstrated ability to effectively forecast and manage trial budget.
  • Fluent in English (any another European language are an asset).
  • Work permit: Swiss or EC national with appropriate work permit

If your profile matches the above description, we are looking forward to your application.

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