Medical affairs Jobs in San Diego, CA

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 Director, Medical Affairs Research Operations, plays an integral role in supporting the Medical Affairs team. This position provides operational and scientific support of investigator-initiated trials, to ensure their successful implementation. This individual is responsible for activities associated with activation, tracking, and reporting of study-related information. This role will work cross-functionally with several departments (Clinical Operations, CMC, Regulatory Affairs, Supply Chain, Drug Safety / PV, Compliance and Legal).

Responsibilities :

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

• Provide operational expertise and lead the Investigator Initiated Trial (IIT) program with functional area oversight to ensure quality of work and appropriate compliance with regulatory requirements
• Conduct budget negotiations for Medical Affairs IITs, including fair market value assessments for all study related items. Create process for internal review of budgeting of trials
• Maintain all internal records and databases associated with IIT program and develop reports when required
• Create departmental SOPs and maintain these documents over time. Conduct training for cross-functional partners on appropriate processes
• Ensure that processes allow for activation of studies in a timely fashion consistent with the developed SOPs. Assist in activation workflow to ensure all study timelines are met
• Create IIT strategy with cross functional team members both within medical affairs as well as clinical development, clinical operations, regulatory, legal, etc
• Collaborate with operations to ensure drug shipments, milestones, etc. are aligned to study specific timelines
• Work with regulatory affairs to ensure that all investigator-initiated trials adhere to relevant regulatory guidelines, including IRB approvals and IND submissions
• Maintain safety data from all trials to ensure patient safety and necessary documentation for any regulatory needs
• Assess all IIT invoicing and perform budget reconciliation upon any changes within IIT protocols
• Assist with other duties related to the operations of the IST program, including facilitation and management of cross-functional work-streams
• Ability to travel (US and International) approximately 25% of time

Education and Experience :

Skills and Qualifications :

Physical Demands :

Work Environment :

RayzeBio

LI-Onsite

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 /

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