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Associate Director Clinical Site Operations

3 months ago

Township of Lawrence, United States Bristol-Myers Squibb Full time

**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 rich in diversity. Take your career farther than you thought possible.

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC). Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

**Summary**

The Associate 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 Associate Director Clinical Site Operations will also ensure that such operations activities are timely, efficient, and of the highest quality.

**Responsibilities**:
Essential duties and responsibilities include the following. Other duties may be assigned.
- 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

**Skills and Qualifications**
- 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.

**Education and Experience**
- Minimum 10 years of 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

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is