Description
Imagine that you are the director of a safety reporting division in a large pharmaceutical company and you are responsible for notifying leadership when safety events threaten a study’s conduct. The particular trial you are working on has received global attention for its early results and its potential benefit for cancer patients. You have been diligently following the safety reports and have found an alarming trend over the past few months. Adverse events are being coded differently by site investigators. In fact, there have been multiple discrepancies found in the same patient when they have been seen by multiple providers on the same day.
You are concerned about the data and the processes for collecting, assessing, and assigning attribution to the event. Because of the accelerated time frame around this study, there are no training or technical solutions. You must integrate patient reporting tools to confirm and clarify the events immediately. You know this integration will threaten the relationships you have with the principal investigator team. In fact, you have already heard from several lead investigators that they have felt insulted by your double-checking of their assessments. Tensions are rising, and a few investigators are threatening to stop enrolling subjects in the trial. While you value their independence and qualifications, you know the environment is changing and you must help the others face these difficult challenges and new circumstances.
You are already scheduled to meet with the key investigators at an annual academic meeting in several days, so you must plan how to mobilize the investigators to accept change.
You need to be the one who puts the issue on the table and then help the group work through the pain, loss, and tension to find a solution. Use several or all of the six adaptive leadership behaviors outlined in Northouse (pp. 262–271) to ground your adaptive leadership approach:
Get on the balcony.
Identify the adaptive challenge.
Regulate distress.
Maintain disciplined attention.
Give the work back to the people.
Protect leadership voices from below.
Remember, create a safe environment so people are able to confront changes in their roles, priorities, and values. Write a two- to three-page paper summarizing your approach and plan. Begin with your assessment of the challenge, and state whether it is technical, adaptive, or a combination, and support why you think this is the case.
Length: 2-3 pages, either double-spaced or written as a well-supported outline.
Use APA (7th edition) style for citations.
You must submit a Word document.
