Director, Clinical Site Operations

Bristol Myers Squibb

1d • Remote

About The Position

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals Summary The Director, Clinical Site Operations provides strategic oversight, leadership and management of clinical trial execution, including oversight of site management and monitoring, consistent with RayzeBio corporate goals and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state regulations. The Director, Clinical Site Operations will also ensure that such operations activities are timely, efficient, and of the highest quality.

Requirements

• Minimum 10 years clinical operations experience within biotech, pharma or CRO industry
• Proven experience in clinical research as team lead in clinical functions
• BA/BS degree, scientific or healthcare discipline preferred
• Independent professional who proactively communicates frequently and effectively.
• Organized and able to work on multiple projects with tight deadlines.
• High energy level; positive attitude; works well under stress; assertive and effective communicator.
• Hands-on, action-oriented, and able to implement effectively.

Responsibilities

• Directs the operational oversight and execution of clinical site start-up, management and monitoring in accordance with RayzeBio SOPs, ICH Guidelines, and Good Clinical Practices (GCP) to ensure overall data quality, integrity, and patient protection and safety
• Manages CRO relationship and oversight to ensure the appropriate scope of work, oversight and training of the clinical team, investigators and site staff as well as the achievement of study milestones within agreed upon timelines and budget
• Develops collaborative relationships with investigative sites
• Communicates clinical site performance data to the Head of Clinical Operations and the Clinical Program Management team
• Key contributor to the development, review and approval of study documents including but not limited to RayzeBio SOPs and Clinical Operation Plans
• Liaison with other functional departments to ensure that the highest quality is maintained
• Participate in and/or lead departmental initiatives
• Line management skills and expertise in mentoring and coaching
• Detail oriented, organized and committed to quality and consistency
• Excellent team-interaction skills and ability to work successfully in cross-functional teams
• Ability to work in a dynamic environment with a high degree of flexibility
• Represent RayzeBio at conferences as well as scientific and other business-related meetings as required
• Assists in creating vision for department goals and objectives
• Conduct oversight visits at investigational sites to ensure quality monitoring
• Up to 20% travel required

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees