Associate Director Global Clinical Trials 100%
Global Clinical Trial Lead – Associate Director level
Phase II & III registrational/pivotal studies in immunology, oncology, neurology, rare diseases
Based in Geneva, Poland or UKYour main tasks
- Manages global clinical projects/work streams from A-Z from protocol design & development to execution, governance and review
- Coordinates stakeholders within the matrix organization and influences, motivates, creates and leads
- Develop and lead operational and therapeutic area training for internal and external study team members
- Exhibits Subject Matter Expert level in clinical research area
- Leads the development of the clinical trial strategy and delivers the clinical operational plan within the budget, timelines and quality standards agreed upon by Governance Committees
- Accountable for oversight of CROs in the execution of assigned trials and partnering in audit responses
- Represents Global Development Operations (GDO) within the Global Trial Team and serves as the key GDO operational point of contact for the trial
- Accountable for the successful preparation and presentation of operational content at respective governance bodies (design close-out, inspection filing, etc.)
- Performs review and provides strong operational input in the development of clinical trial protocols, ICFs and CSRs and contributes on the Internal Protocol Review Committee.
- Can lead up to 2 or more complex studies in parallel. Contributes to non-study -related initiatives in addition to study assignments.
- Collaborates & leads negotiations with vendors and partners and verifies each is meeting expectations according to scope of work and budget on multiple assigned studies.
- Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM certification (CPM, PMP) desirable
- At least 10 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 7 years of in-depth knowledge and experience in clinical trial management including global project leadership responsibility
- Proven experience in all aspects of clinical study planning and startup (including protocol design, budget and resource planning) and in executing the complete range of clinical study activities, from startup through final study report
- Experience in phase II / III pivotal studies in the field of oncology, neurology, rare diseases, or immunology
- Leadership competencies and influencing skills
- Expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing)
- Experience in Inspection Readiness with health agencies
Full discretion is guaranteed and we will gladly answer any additional questions.
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