Director, Global Clinical Operations

Daiichi Sankyo US • Basking Ridge, NJ

86d • $198,160 - $297,240

About The Position

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a 'Global Pharma Innovator with Competitive Advantage in Oncology,' Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Requirements

• Bachelor's Degree required in the Sciences preferred.
• 10 or More Years relevant experience required.
• 4 or More Years with a MS/MPH preferred.
• 4 or More Years with PharmD/PhD preferred.
• Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO).
• Preferred CRA experience.
• Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.

Responsibilities

• Align with the Senior Director, Global Clinical Operations on plans for successful implementation of studies.
• Ensure the management of assigned assets at the program level through the operational resources assigned to their program.
• Provide input into the operational aspects of CDP and individual protocols to facilitate successful implementation of their assigned programs.
• Accountable to ensure proper oversight of CROs utilized within their assigned asset.
• Ensure their direct reports and operations team in their assets have proper oversight plans in place for all studies falling under their responsibility.
• Design, update and implement appropriate innovative and best-in-class procedures and SOP’s related to clinical study oversight and execution.
• Ensure their direct reports are maintaining a state of inspection readiness across all activities on their study and making sure quality expectations are met.
• Support operations team members on their responsible asset and their direct reports in setting strategies and plans for their teams with the CROs.
• Responsible to review metrics and issues for their studies and ensure proper attention and mitigations are being applied.
• Develop talent through providing focused career development, performance management and manages retention.
• Fosters a high-quality culture ensuring workload balance, cross functional alignment for roles and responsibilities as well as ensuring communication across lines.
• Responsible for resource management within their therapeutic area.

Benefits

• Exceptional working environment that values and rewards individual contributions.
• Training, tools and technology provided to excel.
• Open communication and emphasis on results.
• Spirit of personal accountability.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees