Senior Director, Risk Management and Central Monitoring

Company: Disability Solutions
Location: Princeton
Posted on: October 19, 2024

Job Description:

Working with UsChallenging. 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: .Senior Director, Risk Management and Central Monitoring Position is a critical member of the Clinical Oversight and Risk Management Leadership Team and accountable to develop and drive Risk Based strategies to enable the efficient and effective execution of clinical trials through monitoring and data oversight. Key strategic and tactical activities include the execution of the strategic vision for the organization, and to enable a highly efficient and engaged organization through operational directives and key initiatives.The role is accountable for defining the RBM strategy, collaborating with stakeholders to ensure buy in and leading the Risk Management and Central Monitoring team, responsible for supporting delivery of reliable clinical trial information for internal decision making, regulatory approval and market acceptance, and ensure a holistic community of practice centered on quality by design, clinical trial risk management, efficient issue management, and continuous improvement.The role will need to play an instrumental role in collaborating and negotiating with VP level peers in the broader Drug Development organization to facilitate risk discussion at portfolio level and would operate for a specific TA The insights that come from the RM_CM TA specific team will be used for decision making at site, study, country, portfolio level. The Senior Director, Risk Management and Central Monitoring, is an industry thought leaders and seeks understanding of what industry best practice is and is engaged in industry leading forums for bringing industry standards in centralized monitoring into BMS.This role is expected to be in office 50% of the time over 2 weeks per company policy.Key Responsibilities- Drive the development of and deliver the vision, strategy and road map, in partnership with the CORM LT, to build a holistic and integrated Risk Management and Central Monitoring capability and processes to drive proactive risk-based management and related data insights that enable BMS Drug Development to accelerate in performance and safeguarding the well-being of our trial participants.- Lead and shape the Risk Management and Central Monitoring TA specific team, enabling them to lead execution of the Risk Based Management Framework, enhancement of quality, compliance and inspection readiness across the clinical trials (Phase 1-4) in the portfolio.- Lead and manage governance for ongoing review of portfolio risk to support successful delivery of portfolio priorities for specific TA-Is accountable for implementing an effective quality by design and risk-based management approach.- Accountable for monitoring holistic quality of GDO activities across the portfolio, identifying risks and supporting functions to remediate gaps.-GDO point of contact for Quality oversight in RBM implementation, driving best practice and improved quality for clinical trials- Seeks understanding of what industry best practice is and is engaged in industry leading forums for bringing industry standards in centralized monitoring into BMS.-Accountable for the identification and/or escalations of significant operational, quality and compliance risks within established risk management framework and councils. Participates in investigations and mitigation measures.- Develops strong and productive working relationships with key stakeholders throughout BMS, demonstrates the ability to think strategically across R&D, and effectively influence peers and senior management.- Collaborates with Global Development Operations, Quality Assurance, and process owners to ensure that processes, SOPs, oversight, and governance meet the needs of the organization and evolving regulatory expectations.- Provides leadership and oversight to the Risk Management and Central Monitoring process and audits ensuring quality readiness for regulatory inspections.- Develop and implement the strategy to incorporate automation and emerging technologies to support risk identification and management.- Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empower and hold staff to high quality performance and delivery.- Engages and energizes employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities.- Develop and promote a workplace culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability.Qualifications & Experience-A minimum of a Bachelor's degree (or equivalent degree) is required-Degree in a life science, natural science, or business is preferred-Broad knowledge of the global drug development processes is required, with at least 10 years GCP-related experience in clinical operations (e.g. site, sponsor, and/or CRO).- Would operate for a specific TA' so would have relevant TA experience to shape thinking.-Inspection experience is a plus-Experience in and/or knowledge of centralized monitoring and risk management in a regulated industry.-Enterprise Risk Management knowledge is preferred-Experience in managing teams of diverse individuals, ability to operate in a matrix organization and manage competing priorities with a sense of urgency.- Engaged in industry leading forums related to risk management and central monitoring.-The candidate will demonstrate the ability to adopt a biopharma enterprise-wide mindset, to act with speed, accountability, and integrity.- Demonstrated team and matrix leadership, escalation, enterprise and senior leadership alignment.- Knowledge of external health authority and industry trends and emerging areas of interest.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 CareersWith 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 . Visit 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: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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