Head of Clinical Operations and Strategy

Vor 4 Tagen

Basel, Basel-Stadt, Schweiz Ridgeline Discovery GmbH Vollzeit
About the Role

Ridgeline Discovery GmbH is seeking an experienced and dynamic Head of Clinical Operations and Strategy to lead our clinical operations team. This role is crucial for the successful execution of our Phase I – III clinical trials and ensuring the highest standards of quality and compliance.

Key Responsibilities
  • Leadership and Management:
    • Lead, mentor, manage, and work collaboratively with Clinical Study Leads and other clinical operations and supportive roles.
    • Foster an inclusive, collaborative, and high-performance work environment.
    • Develop and implement relevant training programs for team members.
  • Clinical Trial Oversight:
    • Oversee the planning, initiation, and execution of Phase I - III clinical trials.
    • Ensure clinical trials are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and company SOPs.
    • Contribute to the preparation and review of clinical program documents (briefing books, clinical study protocol and consent forms, regulatory documents including submissions to IRBs and ECs, clinical study reports [CSR] and submissions) and other study-related documents, assuring quality and consistency. Monitor trial progress and address any issues that arise.
  • Strategic Planning:
    • Develop and implement clinical operations strategies that align with company goals.
    • Lead the development and ongoing refinement of Program-level study timelines and scenarios to contribute to the CDP, IDP, and other high-level strategic plans.
    • Collaborate with senior management to plan and budget for clinical trials.
    • Create and implement risk assessment and mitigation plans, performing regular reviews to continually assess for changes.
    • Engage with patient advocacy groups to help build patient-focused clinical operations strategies, methods, and tools for use in the clinical studies.
    • Attend seminars, congresses, advocacy meetings, Investigator meetings, program, and sub-team meetings, educational conferences/training sessions.
  • Vendor Management:
    • Select, negotiate, and manage contracts with CROs, laboratories, and other vendors.
    • Ensure vendors meet performance and quality standards.
    • Overall accountability overseeing and driving CRO and other vendor relationships to ensure execution of clinical studies within the Program, within timelines, budget, and with quality.
  • Regulatory Compliance:
    • Ensure all clinical activities comply with local and international regulations.
    • Prepare and review regulatory submissions as needed.
    • Stay current with regulatory changes and updates.
  • Budget and Resource Management:
    • Develop and manage clinical operations budgets.
    • Ensure optimal allocation of resources for clinical trial activities.
  • Stakeholder Communication:
    • Serve as the primary point of contact for internal and external stakeholders regarding clinical operations.
    • Provide regular updates to senior management on trial progress and operational issues.
Requirements
  • Advanced degree in life sciences, medicine, or a related field.
  • Minimum of 10 years of experience in clinical operations, with experience in Phase I trials.
  • Proven track record of successfully managing clinical trials from initiation to completion.
  • Strong knowledge of GCP, regulatory requirements, and clinical trial processes.
  • Excellent leadership and team management skills.
  • Strong strategic thinking and problem-solving abilities.
  • Exceptional communication and interpersonal skills.
  • Ability to travel as required.
About Us

Ridgeline Discovery GmbH is a biotechnology enterprise focused on advancing a portfolio of antibody-based compounds targeting obesity and associated co-morbidities. We are a preclinical stage company with a pipeline of mAbs as well as mAb-peptide conjugates entering IND preparing studies in the next few months. Our team is passionate about science and committed to improving patient outcomes through cutting-edge research and clinical trials.

We offer a dynamic and innovative work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking to make a difference in the field of clinical operations, we encourage you to apply for this exciting opportunity.

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