Sr. Director, Clinical Program Management
Bristol-Myers Squibb
Sr. Director, Clinical Program Management
Job Description
Develop and lead the clinical operational strategy for complex, global programs, setting direction for clinical study teams, CROs, and vendors to ensure study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs and ICH/GCP guidelines. Provide senior oversight and guidance for all operational aspects of clinical trial execution, including planning and feasibility, start-up, conduct, close-out, and reporting. Identify, assess, and proactively manage operational risks and develop mitigation strategies at the program level. Contribute to and provide input on clinical development plans, protocol design, and overall program strategy. Lead and mentor cross-functional study execution teams, ensuring clarity of objectives and accountability for delivery of studies and program goals. Drive management of clinical study timelines, milestone achievement, and regular tracking/reporting of progress to executive leadership. Escalate and resolve critical program issues efficiently, ensuring timely communication to key internal stakeholders and executive leadership. Oversee quality control and performance oversight of CROs and vendors; ensure compliance with performance metrics and inspection readiness. Lead CRO and vendor governance meetings; review operational plans, performance data, and escalate study/program risks as needed. Champion process improvement initiatives to optimize operational effectiveness across programs. Perform additional related duties as assigned. Up to 20% travel required. 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. BA/BS degree, scientific or healthcare discipline preferred Minimum 12 years relevant clinical operations experience in pharmaceutical/biotech industry, with at least 7 years in oncology trials Prior experience in development programs with radiopharmaceuticals, theranostics and/or companion diagnostics highly desirable Independent professional who proactively communicates frequently and effectively. Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making Detail and action-oriented, organized and committed to quality and consistency. Ability to work in a dynamic environment with a high degree of flexibility. Expertise in Microsoft Project and Smartsheets desired.
Key Responsibilities
- Develop and lead the clinical operational strategy for complex, global programs
- Set direction for clinical study teams, CROs, and vendors to ensure studies are completed on time, within budget, and in compliance with RayzeBio SOPs and ICH/GCP guidelines
- Provide senior oversight and guidance for all operational aspects of clinical trial execution, including planning and feasibility, start-up, conduct, close-out, and reporting
- Identify, assess, and proactively manage operational risks and develop mitigation strategies at the program level
- Contribute to and provide input on clinical development plans, protocol design, and overall program strategy
- Lead and mentor cross-functional study execution teams, ensuring clarity of objectives and accountability for delivery of studies and program goals
- Drive management of clinical study timelines, milestone achievement, and regular tracking/reporting of progress to executive leadership
- Escalate and resolve critical program issues efficiently, ensuring timely communication to key internal stakeholders and executive leadership
- Oversee quality control and performance oversight of CROs and vendors; ensure compliance with performance metrics and inspection readiness
- Lead CRO and vendor governance meetings; review operational plans, performance data, and escalate study/program risks as needed
- Champion process improvement initiatives to optimize operational effectiveness across programs
- Perform additional related duties as assigned
Required Qualifications
- BA/BS degree in a scientific or healthcare discipline
- Minimum 12 years of relevant clinical operations experience in the pharmaceutical/biotech industry
- At least 7 years of experience in oncology trials
Preferred Qualifications
- Prior experience in development programs with radiopharmaceuticals, theranostics, and/or companion diagnostics
Skills Required
- Independent professional who proactively communicates frequently and effectively
- Strong leadership and project management skills across complex programs and cross-functional teams
- Ability to drive decision making
- Detail and action-oriented, organized and committed to quality and consistency
- Ability to work in a dynamic environment with a high degree of flexibility
- Expertise in Microsoft Project and Smartsheets
Benefits & Perks
- 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
- Summer hours flexibility
Additional Requirements
- Up to 20% travel required
Locations
- San Diego RayzeBio, Canada
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
150,000 - 250,000 CAD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Independent professional who proactively communicates frequently and effectivelyintermediate
- Strong leadership and project management skills across complex programs and cross-functional teamsintermediate
- Ability to drive decision makingintermediate
- Detail and action-oriented, organized and committed to quality and consistencyintermediate
- Ability to work in a dynamic environment with a high degree of flexibilityintermediate
- Expertise in Microsoft Project and Smartsheetsintermediate
Required Qualifications
- BA/BS degree in a scientific or healthcare discipline (experience)
- Minimum 12 years of relevant clinical operations experience in the pharmaceutical/biotech industry (experience)
- At least 7 years of experience in oncology trials (experience)
Preferred Qualifications
- Prior experience in development programs with radiopharmaceuticals, theranostics, and/or companion diagnostics (experience)
Responsibilities
- Develop and lead the clinical operational strategy for complex, global programs
- Set direction for clinical study teams, CROs, and vendors to ensure studies are completed on time, within budget, and in compliance with RayzeBio SOPs and ICH/GCP guidelines
- Provide senior oversight and guidance for all operational aspects of clinical trial execution, including planning and feasibility, start-up, conduct, close-out, and reporting
- Identify, assess, and proactively manage operational risks and develop mitigation strategies at the program level
- Contribute to and provide input on clinical development plans, protocol design, and overall program strategy
- Lead and mentor cross-functional study execution teams, ensuring clarity of objectives and accountability for delivery of studies and program goals
- Drive management of clinical study timelines, milestone achievement, and regular tracking/reporting of progress to executive leadership
- Escalate and resolve critical program issues efficiently, ensuring timely communication to key internal stakeholders and executive leadership
- Oversee quality control and performance oversight of CROs and vendors; ensure compliance with performance metrics and inspection readiness
- Lead CRO and vendor governance meetings; review operational plans, performance data, and escalate study/program risks as needed
- Champion process improvement initiatives to optimize operational effectiveness across programs
- Perform additional related duties as assigned
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Sr. Director, Clinical Program Management
Bristol-Myers Squibb
Sr. Director, Clinical Program Management
Job Description
Develop and lead the clinical operational strategy for complex, global programs, setting direction for clinical study teams, CROs, and vendors to ensure study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs and ICH/GCP guidelines. Provide senior oversight and guidance for all operational aspects of clinical trial execution, including planning and feasibility, start-up, conduct, close-out, and reporting. Identify, assess, and proactively manage operational risks and develop mitigation strategies at the program level. Contribute to and provide input on clinical development plans, protocol design, and overall program strategy. Lead and mentor cross-functional study execution teams, ensuring clarity of objectives and accountability for delivery of studies and program goals. Drive management of clinical study timelines, milestone achievement, and regular tracking/reporting of progress to executive leadership. Escalate and resolve critical program issues efficiently, ensuring timely communication to key internal stakeholders and executive leadership. Oversee quality control and performance oversight of CROs and vendors; ensure compliance with performance metrics and inspection readiness. Lead CRO and vendor governance meetings; review operational plans, performance data, and escalate study/program risks as needed. Champion process improvement initiatives to optimize operational effectiveness across programs. Perform additional related duties as assigned. Up to 20% travel required. 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. BA/BS degree, scientific or healthcare discipline preferred Minimum 12 years relevant clinical operations experience in pharmaceutical/biotech industry, with at least 7 years in oncology trials Prior experience in development programs with radiopharmaceuticals, theranostics and/or companion diagnostics highly desirable Independent professional who proactively communicates frequently and effectively. Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making Detail and action-oriented, organized and committed to quality and consistency. Ability to work in a dynamic environment with a high degree of flexibility. Expertise in Microsoft Project and Smartsheets desired.
Key Responsibilities
- Develop and lead the clinical operational strategy for complex, global programs
- Set direction for clinical study teams, CROs, and vendors to ensure studies are completed on time, within budget, and in compliance with RayzeBio SOPs and ICH/GCP guidelines
- Provide senior oversight and guidance for all operational aspects of clinical trial execution, including planning and feasibility, start-up, conduct, close-out, and reporting
- Identify, assess, and proactively manage operational risks and develop mitigation strategies at the program level
- Contribute to and provide input on clinical development plans, protocol design, and overall program strategy
- Lead and mentor cross-functional study execution teams, ensuring clarity of objectives and accountability for delivery of studies and program goals
- Drive management of clinical study timelines, milestone achievement, and regular tracking/reporting of progress to executive leadership
- Escalate and resolve critical program issues efficiently, ensuring timely communication to key internal stakeholders and executive leadership
- Oversee quality control and performance oversight of CROs and vendors; ensure compliance with performance metrics and inspection readiness
- Lead CRO and vendor governance meetings; review operational plans, performance data, and escalate study/program risks as needed
- Champion process improvement initiatives to optimize operational effectiveness across programs
- Perform additional related duties as assigned
Required Qualifications
- BA/BS degree in a scientific or healthcare discipline
- Minimum 12 years of relevant clinical operations experience in the pharmaceutical/biotech industry
- At least 7 years of experience in oncology trials
Preferred Qualifications
- Prior experience in development programs with radiopharmaceuticals, theranostics, and/or companion diagnostics
Skills Required
- Independent professional who proactively communicates frequently and effectively
- Strong leadership and project management skills across complex programs and cross-functional teams
- Ability to drive decision making
- Detail and action-oriented, organized and committed to quality and consistency
- Ability to work in a dynamic environment with a high degree of flexibility
- Expertise in Microsoft Project and Smartsheets
Benefits & Perks
- 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
- Summer hours flexibility
Additional Requirements
- Up to 20% travel required
Locations
- San Diego RayzeBio, Canada
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
150,000 - 250,000 CAD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Independent professional who proactively communicates frequently and effectivelyintermediate
- Strong leadership and project management skills across complex programs and cross-functional teamsintermediate
- Ability to drive decision makingintermediate
- Detail and action-oriented, organized and committed to quality and consistencyintermediate
- Ability to work in a dynamic environment with a high degree of flexibilityintermediate
- Expertise in Microsoft Project and Smartsheetsintermediate
Required Qualifications
- BA/BS degree in a scientific or healthcare discipline (experience)
- Minimum 12 years of relevant clinical operations experience in the pharmaceutical/biotech industry (experience)
- At least 7 years of experience in oncology trials (experience)
Preferred Qualifications
- Prior experience in development programs with radiopharmaceuticals, theranostics, and/or companion diagnostics (experience)
Responsibilities
- Develop and lead the clinical operational strategy for complex, global programs
- Set direction for clinical study teams, CROs, and vendors to ensure studies are completed on time, within budget, and in compliance with RayzeBio SOPs and ICH/GCP guidelines
- Provide senior oversight and guidance for all operational aspects of clinical trial execution, including planning and feasibility, start-up, conduct, close-out, and reporting
- Identify, assess, and proactively manage operational risks and develop mitigation strategies at the program level
- Contribute to and provide input on clinical development plans, protocol design, and overall program strategy
- Lead and mentor cross-functional study execution teams, ensuring clarity of objectives and accountability for delivery of studies and program goals
- Drive management of clinical study timelines, milestone achievement, and regular tracking/reporting of progress to executive leadership
- Escalate and resolve critical program issues efficiently, ensuring timely communication to key internal stakeholders and executive leadership
- Oversee quality control and performance oversight of CROs and vendors; ensure compliance with performance metrics and inspection readiness
- Lead CRO and vendor governance meetings; review operational plans, performance data, and escalate study/program risks as needed
- Champion process improvement initiatives to optimize operational effectiveness across programs
- Perform additional related duties as assigned
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories