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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 Ph RMA 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 management processes, regulatory requirements, drug safety requirements, data management and statistical processes, and budget and financial tracking;
• Proven project management skills, including effective planning and organization skills, attention to detail and excellent follow through;
• High level of sensitivity in communication across different levels of hierarchy & across department boundaries (e.g. with Commercial, Global Development, Statistics, Procurement);
• Experience in late phase clinical trials is required;
• Incumbent should have a thorough understanding of Ph RMA and OIG guidelines as well as pharmaceutical industry experience in medical affairs, field medical affairs, scientific publications or key opinion leader activities. Incumbent should have thorough understanding of the forecasting and budgeting process, as well as knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.

Preferred Qualifications:

• Advanced Degree preferred;
• 6+ years of Industry Experience preferred;
• Experience in management of Risk Evaluation Mitigation Strategy Programs is preferred.

Employees can expect to be paid a salary of between $173,762.40 to $260,643.60. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors

This posting will be available for application until at least 9-12-24.

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