Clinical Development Lead (Senior Director), Oncology
Bristol-Myers Squibb
Clinical Development Lead (Senior Director), Oncology
Job Description
Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians May serve as CTP as necessary Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function Partners with Worldwide Patient Safety physicians in the ongoing review of safety data Serves as the (co-)leader of the cross-functional Clinical Development Team Provides clinical leadership and disease area expertise into integrated disease area strategies Partners closely with KOLs in specific indications Serves as Primary Clinical Representative in Regulatory interactions Evaluates strategic options against a given Target Product Profile (TPP) Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed Sets executional priorities and partners with CTP and CS to support executional delivery of studies Accountable for top line data with support of CTP, CS, and Statisticians 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. Supporting People with Disabilities MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge At least 10 years of relevant experience CDL has demonstrated leadership in the design and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader), and exhibits all of the following attributes: Able to synthesize internal and external data to produce a clinical strategy Able to ensure that the clinical program will result in a viable registrational strategy Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio CDL has demonstrated, sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent Verifiable track record of successful people management and development, or leadership in a matrix team (e.g. mentoring junior colleagues) CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s) External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials) Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables
Key Responsibilities
- Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies
- Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians
- May serve as CTP as necessary
- Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs
- Work to proactively partner with CTPs and CSs
- Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents
- Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
- Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
- Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
- Serves as the (co-)leader of the cross-functional Clinical Development Team
- Provides clinical leadership and disease area expertise into integrated disease area strategies
- Partners closely with KOLs in specific indications
- Serves as Primary Clinical Representative in Regulatory interactions
- Evaluates strategic options against a given Target Product Profile (TPP)
- Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed
- Sets executional priorities and partners with CTP and CS to support executional delivery of studies
- Accountable for top line data with support of CTP, CS, and Statisticians
- Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials)
- Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables
Required Qualifications
- MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge
- At least 10 years of relevant experience
- Demonstrated leadership in the design and execution of multiple clinical trials
- Sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent
- Verifiable track record of successful people management and development, or leadership in a matrix team
Skills Required
- Able to synthesize internal and external data to produce a clinical strategy
- Able to ensure that the clinical program will result in a viable registrational strategy
- Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts
- Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio
- Demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s)
- External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS
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
- Supporting People with Disabilities
Locations
- Princeton NJ, United States
- Cambridge Crossing MA, United States
- Madison Giralda NJ, United States
- Boudry, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
250,000 - 350,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Able to synthesize internal and external data to produce a clinical strategyintermediate
- Able to ensure that the clinical program will result in a viable registrational strategyintermediate
- Able to assess personnel needs, translate into a hiring strategy, and lead the hiring effortsintermediate
- Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfoliointermediate
- Demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s)intermediate
- External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMSintermediate
Required Qualifications
- MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge (experience)
- At least 10 years of relevant experience (experience)
- Demonstrated leadership in the design and execution of multiple clinical trials (experience)
- Sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent (experience)
- Verifiable track record of successful people management and development, or leadership in a matrix team (experience)
Responsibilities
- Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies
- Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians
- May serve as CTP as necessary
- Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs
- Work to proactively partner with CTPs and CSs
- Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents
- Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
- Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
- Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
- Serves as the (co-)leader of the cross-functional Clinical Development Team
- Provides clinical leadership and disease area expertise into integrated disease area strategies
- Partners closely with KOLs in specific indications
- Serves as Primary Clinical Representative in Regulatory interactions
- Evaluates strategic options against a given Target Product Profile (TPP)
- Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed
- Sets executional priorities and partners with CTP and CS to support executional delivery of studies
- Accountable for top line data with support of CTP, CS, and Statisticians
- Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials)
- Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables
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
- general: Supporting People with Disabilities
Tags & Categories
Clinical Development Lead (Senior Director), Oncology
Bristol-Myers Squibb
Clinical Development Lead (Senior Director), Oncology
Job Description
Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians May serve as CTP as necessary Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function Partners with Worldwide Patient Safety physicians in the ongoing review of safety data Serves as the (co-)leader of the cross-functional Clinical Development Team Provides clinical leadership and disease area expertise into integrated disease area strategies Partners closely with KOLs in specific indications Serves as Primary Clinical Representative in Regulatory interactions Evaluates strategic options against a given Target Product Profile (TPP) Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed Sets executional priorities and partners with CTP and CS to support executional delivery of studies Accountable for top line data with support of CTP, CS, and Statisticians 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. Supporting People with Disabilities MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge At least 10 years of relevant experience CDL has demonstrated leadership in the design and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader), and exhibits all of the following attributes: Able to synthesize internal and external data to produce a clinical strategy Able to ensure that the clinical program will result in a viable registrational strategy Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio CDL has demonstrated, sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent Verifiable track record of successful people management and development, or leadership in a matrix team (e.g. mentoring junior colleagues) CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s) External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials) Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables
Key Responsibilities
- Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies
- Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians
- May serve as CTP as necessary
- Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs
- Work to proactively partner with CTPs and CSs
- Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents
- Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
- Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
- Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
- Serves as the (co-)leader of the cross-functional Clinical Development Team
- Provides clinical leadership and disease area expertise into integrated disease area strategies
- Partners closely with KOLs in specific indications
- Serves as Primary Clinical Representative in Regulatory interactions
- Evaluates strategic options against a given Target Product Profile (TPP)
- Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed
- Sets executional priorities and partners with CTP and CS to support executional delivery of studies
- Accountable for top line data with support of CTP, CS, and Statisticians
- Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials)
- Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables
Required Qualifications
- MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge
- At least 10 years of relevant experience
- Demonstrated leadership in the design and execution of multiple clinical trials
- Sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent
- Verifiable track record of successful people management and development, or leadership in a matrix team
Skills Required
- Able to synthesize internal and external data to produce a clinical strategy
- Able to ensure that the clinical program will result in a viable registrational strategy
- Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts
- Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio
- Demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s)
- External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS
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
- Supporting People with Disabilities
Locations
- Princeton NJ, United States
- Cambridge Crossing MA, United States
- Madison Giralda NJ, United States
- Boudry, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
250,000 - 350,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Able to synthesize internal and external data to produce a clinical strategyintermediate
- Able to ensure that the clinical program will result in a viable registrational strategyintermediate
- Able to assess personnel needs, translate into a hiring strategy, and lead the hiring effortsintermediate
- Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfoliointermediate
- Demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s)intermediate
- External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMSintermediate
Required Qualifications
- MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge (experience)
- At least 10 years of relevant experience (experience)
- Demonstrated leadership in the design and execution of multiple clinical trials (experience)
- Sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent (experience)
- Verifiable track record of successful people management and development, or leadership in a matrix team (experience)
Responsibilities
- Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies
- Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians
- May serve as CTP as necessary
- Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs
- Work to proactively partner with CTPs and CSs
- Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents
- Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
- Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
- Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
- Serves as the (co-)leader of the cross-functional Clinical Development Team
- Provides clinical leadership and disease area expertise into integrated disease area strategies
- Partners closely with KOLs in specific indications
- Serves as Primary Clinical Representative in Regulatory interactions
- Evaluates strategic options against a given Target Product Profile (TPP)
- Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed
- Sets executional priorities and partners with CTP and CS to support executional delivery of studies
- Accountable for top line data with support of CTP, CS, and Statisticians
- Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials)
- Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables
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
- general: Supporting People with Disabilities
Tags & Categories