Senior Director, Clinical Data Management San Diego - RayzeBio - CA R1604426 Posted a day ago
$261.11k - $316.4kBristol-Myers Squibb
- # Senior Director, Clinical Data ManagementSan Diego - RayzeBio - CAFind out how well you match with this jobAt RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: Senior Director, Head of Data Management, will lead data management activities for clinical development. This role is critical in establishing and managing data management strategy, ensuring high-quality database build, data integrity, and inspection readiness to support pivotal studies and regulatory submissions.The Senior Director will provide leadership across studies and programs, collaborating cross-functionally to ensure aligned data strategies, while driving efficiencies through process standardization, SOP development, vendor oversight, and implementation of automation and advanced technologies.**Job Responsibilities*** Lead and oversee data management activities across the clinical portfolio, ensuring high-quality, timely, and compliant data deliverables for all studies* Provide strategic leadership for data management in support of NDA submissions, including database lock, submission readiness, and regulatory inspection preparedness* Build, lead, and develop the data management team, including hiring, performance management, and capability development* Serve as the primary interface with external partners to ensure alignment on data standards, processes and resource planning* Oversee vendor strategy and performance across all studies, including selection, budget management, timeline oversight, and quality assurance* Drive standardization of data management processes and lead development and implementation of SOPs to support scalable and inspection-ready operations* Establish and maintain efficient database build, data cleaning, and data review processes across studies, ensuring consistency and quality* Lead database strategy, including build, validation, and lock processes across studies, ensuring timely and high-quality delivery* Partner cross-functionally with Clinical Operations, Clinical Development, Biostatistics, and Safety to ensure alignment on study execution and data quality**Skills and Knowledge:*** Strong knowledge and experience of EDC systems (Medidata RAVE or Veeva).* Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines and FDA regulations.* Excellent verbal and written communication skills.* Strong analytical and problem-solving abilities.**Basic Requirements:*** Bachelor’s or Master’s degree in Life Sciences, Computer Science, Mathematics, Health Sciences, or a related field required.* Minimum of 12 years data management experience in pharmaceutical/biotech/CRO industry.* Demonstrated experience in team leadership and management. Ability to guide, mentor, and develop team members.* In-depth experience in the Oncology therapeutic area is required.* Proven ability to manage CRO relationships and oversee data management deliverables.* Experience utilizing AI-enabled tools to improve productivity and work efficiency.**Preferred Requirements:*** Experience with Veeva EDC system* Radiopharmaceutical experience preferred.**Physical demands*** While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.**Work Environment**The noise level in the work environment is usually moderate.*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.*******Compensation Overview:******San Diego - RayzeBio - CA: $261,110 - $316,404 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. 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 offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:* **Health Coverage:** Medical, pharmacy, dental, and vision care.* **Wellbeing Support:** Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).* **Financial Well-being and Protection:** 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.**Work-life benefits include:**Paid Time Off* US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)* Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidaysBased on eligibility\*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.***\*Eligibility Disclosure:** *T*he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.***RayzeBio and Bristol Myers Squibb**RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.**Supporting People with Disabilities**BMS and RayzeBio are 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 View email address on click.appcast.io. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.**Candidate Rights**BMS and RayzeBio 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: Protection**We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at View email address on click.appcast.io. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response.R1604426 : Senior Director, Clinical Data Management
- J-18808-Ljbffr Bristol-Myers Squibb
Vacancy posted 7 hours ago
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