Job Information
Bristol Myers Squibb Associate Director, Risk Management and Centralized Monitoring in San Diego, California
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 .
Position Summary
The Associate Director, Risk Management and Central Monitoring (AD), is a member of the Risk Management and Central Monitoring team under Clinical Oversight and Risk Management (CORM).
The Risk Management and Central Monitoring capability is a critical element of the Risk Based Management (RBM) framework and will drive and support the strategic direction of Risk Based Management within the business.
Each AD will be assigned a significant part of the Bristol-Myers Squibb clinical trial portfolio and will work conjunctly with their peers to ensure consistency across the function in conducting risk oversight to identify potential risks and control strategies. This role is responsible for the remote assessment of risk and data quality analytics that monitor issues and identify emerging risks in Asset/Portfolio/TU variables (trends / outliers / unusual patterns) through the review of aggregate clinical and operational data leveraging powerful statistical methodologies.
The AD will be responsible for Asset/Portfolio/TA risk analysis and reporting and will be key contributor to the Clinical Development Team to support the oversight of compliance, patient safety, data quality and reliability.
The AD role has accountability to evaluate, monitor, escalate and report risks to the Sr Director Risk Management and Central Monitoring and/or Global Program Team that could potentially have a broad significant and/or systemic impact on quality, compliance, and operational deliverables for discussion with the relevant Governance Committee.
The AD forms a key partnership with the CORM colleagues, R&D Quality (Risk Governance and Operations), applicable GDO & TA functions and their leaders.
Duties/Responsibilities
AD is accountable for ensuring a high quality and consistent Protocol De-risking process is applied to studies within their portion of the portfolio, resulting in a robust Integrated Risk Management Plan (IRMP) which is maintained and kept relevant throughout the lifecycle of the study
AD ensures a high quality and consistent holistic data review strategy is applied to studies within their portion of the portfolio, resulting in a robust Integrated Data Review Plan (IDRP)
Responsible for regular risk monitoring for their allocated portion of the portfolio and providing a holistic risk report at the agreed frequency.
Ensure appropriate escalations of emerging risks (including QTL deviations) to the relevant governance committee (e.g. Quality Council/Therapeutic Area leadership) and proactively shares knowledge and insights across the CORM group.
Connects the outcomes of Risk Review Meetings of studies within their portion of the portfolio to their additional risk analyses in order to feed into higher level risk logs via a compelling 'risk story' at asset/portfolio/TA level
Lead or contribute to the development and maintenance of metrics that inform the evaluation of risk monitoring performance and effectiveness.
Leadership or participation in large strategic initiatives / continuous improvement opportunities within the CORM and broader organizations
Drive and support the strategic direction of Risk Based Management within the business to include leadership of RBM innovation (including representing the Company in interactions with key external partners as part of any committee or industry group relating to RBM), education and embedding
Ensure effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing Risk Management or Central Monitoring activities on behalf of BMS
Develop strong and productive working relationships with key stakeholders throughout TDS, GDO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management
Coach, mentor and develop new team members.
Develop and promote a workplace culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability
Takes on additional responsibilities as directed by leadership
Reporting Relationship
- This role will report to a member of the Risk Management and Central Monitoring Leadership Team within the CORM organization.
Qualifications
A minimum of a bachelor's degree in one of the following disciplines or related field: Life Sciences (preferred); Analytics; Data Science; Statistics; Business; is required.
At least 8 years in the pharmaceutical industry with sound understanding of drug development and 5 years of experience in clinical trial operations and/or Good Clinical Practice is expected.
Significant expertise in Risk-Based Monitoring principles (Quality by Design, Risk Assessment & Control) and relevant tools (e.g RACT, risk analytics platforms, Veeva and other quality systems)
Technical expert in data analysis and interpretation using data visualizations to derive meaningful insights; and an ability to effectively tell the story of the data findings
Ability to lead the development and implementation of data visualizations and analyses to support Risk Management / Central Monitoring business needs.
Expertise in GCP, compliance and regulatory expectations with significant experience of audits and health authority inspections, root cause analysis and CAPA.
Outstanding Leadership skills with an ability to influence and manage key internal stakeholders (including senior leadership) as well as external stakeholders (including Health Authorities).
Excellent communication, collaboration and teamwork skills with an ability to drive cross-functional stakeholders (including senior leaders) to consensus and resolve conflict in a constructive manner.
Ability to understand organizational and industry direction, anticipate future trends, opportunities, and challenges and adjust strategies accordingly.
Open mindset with an ability to be flexible, responsive, and proactive in addressing new challenges, opportunities, and demands.
Ability to articulate a clear, compelling vision for change that inspires and motivates others.
The starting compensation for this job is a range from $168,000 -$210,000, 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. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/ .
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.
Company: Bristol-Myers Squibb
Req Number: R1590755
Updated: 2025-04-06 04:36:01.938 UTC
Location: Uxbridge-GB
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.