Director, USMA Clinical Operations

 

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Director, USMA Clinical Operations 

 

Lead and manage strategic and tactical plans for the execution of assigned Post Marketing Company Sponsored Studies.  The Director, USMA Clinical Operations is critical to the planned dissemination of key scientific data which may generate signals for future Bayer development of our products, fills gaps in the scientific and business knowledge of the use of Bayer products, and build on the value story for our key products.  These trials generate key scientific data which may produce signals for future Bayer development of our products and fills gaps in scientific knowledge through execution of global and local post market interventional clinical trials, observational clinical trials and health economic trials. 

 

Candidates need to be based on the East Coast.

 

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Director, USMA Clinical Operations, are to:

 

• Responsible for the strategic planning, oversight and execution of large complex post market interventional clinical trials, post marketing commitment studies, Collaborative clinical trials (included but not limited to study initiation, recruitment, forecasting, budget and study medication management);
• Anticipates and proactively resolves challenges affecting delivery of goals and objectives and liaises with a cross-functional team to effect solutions within their study.  May be required to interact with regulatory authorities if required for the study;  
• Develops and implements study related tactical processes and documents from study initiation, forecasting, budget and study medication management;                                                                                                 
• Responsible for the development of quality project documentation including project plans ie resources plans, risks plans, and communication plans through the life of the project and ensures appropriate application of documents;
• Effectively manage external vendors (ie Clinical Research Organization, Interactive Web Response System) to ensure study is successful delivered on expectations of quality, timelines and budget;
• Evaluates Study processes, contracts and documentation to ensure adherence to corporate Compliance and Legal guidelines and/or requirements. Collaborates directly with Legal, Compliance, Regulatory, and Drug Safety in order to address issues or further clarify policies. Responsible for promoting adherence to the Bayer Healthcare Compliance Program including, but not limited to, the Bayer Healthcare Code of Conduct and applicable Policies, Procedures, and applicable SOPs, GCP, OIG regulations and PhRMA guidelines;
• Leads and mobilize clinical trial team to ensure cross functional team member tasks are completed within required study timelines and are accountable for deliverables;
• Participate in talent development and mentoring of junior clinical team members; 
• If Applicable, Manage external consultations to ensure smooth and compliant implementation of REMS program(s) including the monitoring and verification of task delivery/completion. Lead the review and finalization of REMS documentation and provide status reports to management. Manage vendor budget and deliverable timelines.

 

WHO YOU ARE

 

Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

• Bachelor’s degree;
• Experience within the pharmaceutical industry directly related to driving industry-sponsored clinical trials;
• In-depth knowledge of the clinical trial management process including, monitoring and study manage