Abbott Associate Director Clinical Operations, Non-Interventional Research in Basel, Switzerland

Abbott Established Pharmaceutical Division (EPD) is looking for a

Associate Director Clinical Operations - Non Interventional Research

In this role you are responsible for the oversight and compliant execution of Medical Affairs driven research activities:

  • Non Interventional Organised Data Collection initiatives, including Non Interventional-and Real World Evidence studies

  • Investigator Initiated Studies

Main Responsibilities

Medical Affairs Research Activities :

  • Serves as operational subject matter expert and primary point of contact for research projects driven by Medical Affairs at a global or regional / affiliate level

  • Act as liaison between Clinical Operations and other cross – functional stakeholders in the conduct of Medical Affairs research activities. (Medical Affairs, Biometrics Data Centre , Pharmacovigilance, Regulatory, Quality Assurance, Commercial)

  • Establishes and maintains the global operational and procedural framework for the compliant conduct of Medical Affairs research activities

  • Supervises the Therapeutic Area Review Committee process for Medical Affairs research activities

  • Provides oversight for all types of Medical Affairs research projects at the global or regional / affiliate level

  • Provides operational leadership for global Medical Affairs research projects including planning and execution in close collaboration with Global Medical Affairs and the Data Science team.

  • Provides hands-on operational support to affiliates/regions in the conduct of Medical Affairs research activities including planning and execution

Systems, Policies and Procedures

  • Ensures compliance of Medical Affairs research activities according to Abbott policies, procedures, ICH/GCP and regulatory standards

  • Leads the development, implementation, maintenance, and continuous improvement of policies and procedures to support global, area and affiliate medical affairs research activities

  • Leads and manages the implementation and maintenance of all business systems utilized within Clinical Operations

  • Ensures proper procedural training of all staff involved in Medical Affairs research activities including affiliate medical teams

Inspection Readiness

  • Ensures inspection readiness at a global level

  • Supports achievement and maintenance of inspection readiness at the affiliate level

  • Leads the planning and conduct of relevant audits and inspections at a global level

Medical Training​

  • Identify, on an ongoing basis, operational training needs throughout Medical Affairs, and coordinate training delivery, where appropriate Supports affiliates in the training and on-boarding of newly hired medical staff

This position does not have direct reports but will might include direct reporting of Clinical Trial management resources and will have Regional Medical Affairs Operations Managers (India, Emerging Markets and Latin America) as indirect reports

Your Profile

  • Bachelor/Master of Science in a field related to life sciences or equivalent by experience, PhD welcome

  • At least 10 year experience in managerial role Clinical / Medical Affairs Operations

  • Significant Expertise in Operational Leadership Non Interventional Studies – Real World Evidence

  • Significant Expertise in process & compliance related work

  • Exposure to managing relationship with Commercial leadership

  • Exposure beyond Clinicla Operations (Medicla Affairs, Pharmacovigilance, Regulatory, Quality Assurance) is a plus

  • Experience in Global -Matrix organisation

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com