Associate Director, Global Clinical Operations

Your main responsibilities

• 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

• Manages global clinical projects/work streams from A-Z from protocol design & development to execution, governance and review

• Coordinates stakeholders within the matrix organization

• Develops and leads trainings for internal and external study team members

• Exhibits Subject Matter Expert level in clinical research and the Therapeutic Area managed

• 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.

• Leads 2 or more complex global clinical studies in parallel.

• Collaborates & leads negotiations with vendors and partners and verifies each is meeting expectations according to scope of work and budget on multiple assigned studies.

   

Your Qualifications

• Advanced degree desirable (MPH, MS, MA, MBA, PharmD)

• At least 10 years in clinical research in a CRO or Pharmaceutical/Biotechnology company, 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 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

Sebastian Pal is looking forward to receiving your application:

reference number: 2312

by mail to jobs@aurigavision.com or through our website www.aurigavision-stellenmarkt.ch.
Full discretion is guaranteed and we will gladly answer any additional questions.