Sr. Manager, Clinical Program Management -Clinical Operations

Posted:
9/23/2024, 5:07:07 AM

Experience Level(s):
Senior

Field(s):
Operations & Logistics ⋅ Product

Workplace Type:
Hybrid

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.

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.

The Sr. Manager, Clinical Program Management is responsible for the oversight, planning and delivery of assigned clinical study(ies) within the RayzeBio programs, including oversight and management of the study Clinical Research Organization (CRO) and Vendors according to and in compliance with corporate and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state regulations, in order to achieve established study goals within timelines and budget and of the highest quality.

Job Responsibilities:

Essential duties and responsibilities include the following.  Other duties may be assigned.

  • Manage global clinical study teams, CROs and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs, FDA regulations and ICH/GCP guidelines

  • Leads the cross-functional study execution team in achieving the study goals and deliverables

  • Plan and execute study timelines

  • Develop and manage risk mitigation strategies for clinical studies

  • Tracks, monitors and reports on study progress and proactively escalates issues to key internal stakeholders to ensure timely resolution of issues

  • Manage study CRO and vendor budgets and invoicing procedures according to study contract

  • Perform oversight review and quality control of CRO and vendor scope of activities, ensuring compliance to key performance metrics and overall inspection readiness

  • Active participant in CRO and vendor meetings, responsible to review key CRO and vendor study operational plans and provides input to operational strategy, including country and site feasibility and start-up

  • Summarizes CRO and vendor performance data and escalates study risks to the Head of Clinical Operations

  • Performs other related duties as assigned

  • Up to 20% travel required

Education and Experience:

  • Minimum 5-7 years clinical operations experience within biotech, pharma or CRO industry

  • BA/BS degree, scientific or healthcare discipline preferred

Skills and Qualifications:

  • Independent professional who proactively communicates frequently and effectively.

  • Detail and action-oriented, organized and committed to quality and consistency.

  • Ability to work successfully in cross-functional teams.

  • Ability to work in a dynamic environment with a high degree of flexibility.

  • Expertise in Microsoft Project and Smartsheets desired.

Work Environment:

  • The noise level in the work environment is usually moderate.

The starting compensation for this job is a range from $142,000-$193,000.00 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. 

                                 

#RayzeBio #LI-Remote

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.