Associate Director, Senior Clinical Scientist
Bristol-Myers Squibb
Associate Director, Senior Clinical Scientist
Job Description
The Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. Responsible for implementation, planning, and execution of assigned clinical trial activities. Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership) Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members Plan and lead the implementation all study startup/conduct/close-out activities as applicable Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead) Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing) Site-facing activities such as training and serving as primary contact for clinical questions Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team Clinical data trend identification; provide trends and escalate questions to Medical Monitor Develop clinical narrative plan; review clinical narratives Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc. Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses) Collaborate and serve as primary liaison between external partners for scientific advice Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). MD in Pharmacology preferred. 10+ years of experience in clinical science, clinical research, or equivalent Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations. Medical monitoring experience. Proficient knowledge and skills to support program specific data review, trend identification, data interpretation Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees Excellent verbal, written, communication and interpersonal skills Must be able to effectively communicate and collaborate across functions and job levels Ability to assimilate technical information quickly Routinely takes initiative Detail-oriented Strong sense of teamwork; ability to lead team activities Proficient in Medical Terminology and medical writing skills Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile) Proficient critical thinking, problem solving, decision making skills Understanding of functional and cross-functional relationships Commitment to Quality Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals) Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
About the Role/Company
- The Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs
Key Responsibilities
- Implement, plan, and execute assigned clinical trial activities
- Provide scientific and clinical leadership to a team of supporting Clinical Scientists
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Plan and lead the implementation of all study startup/conduct/close-out activities as applicable
- Evaluate innovative trial designs in collaboration with Medical Monitor/Clinical Development Lead
- Participate in protocol and ICF development process with minimal guidance, including writing, reviewing, adjudication/resolution of cross-functional comments and ensuring high clinical quality
- Engage in site-facing activities such as training and serving as primary contact for clinical questions
- Manage activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
- Identify clinical data trends; provide trends and escalate questions to Medical Monitor
- Develop clinical narrative plan; review clinical narratives
- Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings
- Support Study committee (e.g., DMC) activities
- Draft, review, and validate clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Collaborate and serve as primary liaison between external partners for scientific advice
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field)
- 0+ years of experience in clinical science, clinical research, or equivalent
Preferred Qualifications
- MD in Pharmacology
- Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
Skills Required
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Medical monitoring experience
- Proficient knowledge and skills to support program-specific data review, trend identification, data interpretation
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
- Excellent verbal, written, communication, and interpersonal skills
- Ability to effectively communicate and collaborate across functions and job levels
- Ability to assimilate technical information quickly
- Routinely takes initiative
- Detail-oriented
- Strong sense of teamwork; ability to lead team activities
- Proficient in Medical Terminology and medical writing skills
- Proficient critical thinking, problem solving, decision making skills
- Understanding of functional and cross-functional relationships
- Commitment to Quality
- Adaptable/Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
80,000 - 120,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operationsintermediate
- Medical monitoring experienceintermediate
- Proficient knowledge and skills to support program-specific data review, trend identification, data interpretationintermediate
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committeesintermediate
- Excellent verbal, written, communication, and interpersonal skillsintermediate
- Ability to effectively communicate and collaborate across functions and job levelsintermediate
- Ability to assimilate technical information quicklyintermediate
- Routinely takes initiativeintermediate
- Detail-orientedintermediate
- Strong sense of teamwork; ability to lead team activitiesintermediate
- Proficient in Medical Terminology and medical writing skillsintermediate
- Proficient critical thinking, problem solving, decision making skillsintermediate
- Understanding of functional and cross-functional relationshipsintermediate
- Commitment to Qualityintermediate
- Adaptable/Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalismintermediate
- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)intermediate
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting toolsintermediate
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field) (experience)
- 0+ years of experience in clinical science, clinical research, or equivalent (experience)
Preferred Qualifications
- MD in Pharmacology (experience)
- Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile) (experience)
Responsibilities
- Implement, plan, and execute assigned clinical trial activities
- Provide scientific and clinical leadership to a team of supporting Clinical Scientists
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Plan and lead the implementation of all study startup/conduct/close-out activities as applicable
- Evaluate innovative trial designs in collaboration with Medical Monitor/Clinical Development Lead
- Participate in protocol and ICF development process with minimal guidance, including writing, reviewing, adjudication/resolution of cross-functional comments and ensuring high clinical quality
- Engage in site-facing activities such as training and serving as primary contact for clinical questions
- Manage activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
- Identify clinical data trends; provide trends and escalate questions to Medical Monitor
- Develop clinical narrative plan; review clinical narratives
- Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings
- Support Study committee (e.g., DMC) activities
- Draft, review, and validate clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Collaborate and serve as primary liaison between external partners for scientific advice
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Associate Director, Senior Clinical Scientist
Bristol-Myers Squibb
Associate Director, Senior Clinical Scientist
Job Description
The Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. Responsible for implementation, planning, and execution of assigned clinical trial activities. Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership) Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members Plan and lead the implementation all study startup/conduct/close-out activities as applicable Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead) Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing) Site-facing activities such as training and serving as primary contact for clinical questions Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team Clinical data trend identification; provide trends and escalate questions to Medical Monitor Develop clinical narrative plan; review clinical narratives Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc. Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses) Collaborate and serve as primary liaison between external partners for scientific advice Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). MD in Pharmacology preferred. 10+ years of experience in clinical science, clinical research, or equivalent Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations. Medical monitoring experience. Proficient knowledge and skills to support program specific data review, trend identification, data interpretation Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees Excellent verbal, written, communication and interpersonal skills Must be able to effectively communicate and collaborate across functions and job levels Ability to assimilate technical information quickly Routinely takes initiative Detail-oriented Strong sense of teamwork; ability to lead team activities Proficient in Medical Terminology and medical writing skills Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile) Proficient critical thinking, problem solving, decision making skills Understanding of functional and cross-functional relationships Commitment to Quality Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals) Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
About the Role/Company
- The Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs
Key Responsibilities
- Implement, plan, and execute assigned clinical trial activities
- Provide scientific and clinical leadership to a team of supporting Clinical Scientists
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Plan and lead the implementation of all study startup/conduct/close-out activities as applicable
- Evaluate innovative trial designs in collaboration with Medical Monitor/Clinical Development Lead
- Participate in protocol and ICF development process with minimal guidance, including writing, reviewing, adjudication/resolution of cross-functional comments and ensuring high clinical quality
- Engage in site-facing activities such as training and serving as primary contact for clinical questions
- Manage activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
- Identify clinical data trends; provide trends and escalate questions to Medical Monitor
- Develop clinical narrative plan; review clinical narratives
- Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings
- Support Study committee (e.g., DMC) activities
- Draft, review, and validate clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Collaborate and serve as primary liaison between external partners for scientific advice
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field)
- 0+ years of experience in clinical science, clinical research, or equivalent
Preferred Qualifications
- MD in Pharmacology
- Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
Skills Required
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Medical monitoring experience
- Proficient knowledge and skills to support program-specific data review, trend identification, data interpretation
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
- Excellent verbal, written, communication, and interpersonal skills
- Ability to effectively communicate and collaborate across functions and job levels
- Ability to assimilate technical information quickly
- Routinely takes initiative
- Detail-oriented
- Strong sense of teamwork; ability to lead team activities
- Proficient in Medical Terminology and medical writing skills
- Proficient critical thinking, problem solving, decision making skills
- Understanding of functional and cross-functional relationships
- Commitment to Quality
- Adaptable/Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
80,000 - 120,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operationsintermediate
- Medical monitoring experienceintermediate
- Proficient knowledge and skills to support program-specific data review, trend identification, data interpretationintermediate
- Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committeesintermediate
- Excellent verbal, written, communication, and interpersonal skillsintermediate
- Ability to effectively communicate and collaborate across functions and job levelsintermediate
- Ability to assimilate technical information quicklyintermediate
- Routinely takes initiativeintermediate
- Detail-orientedintermediate
- Strong sense of teamwork; ability to lead team activitiesintermediate
- Proficient in Medical Terminology and medical writing skillsintermediate
- Proficient critical thinking, problem solving, decision making skillsintermediate
- Understanding of functional and cross-functional relationshipsintermediate
- Commitment to Qualityintermediate
- Adaptable/Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalismintermediate
- Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)intermediate
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting toolsintermediate
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field) (experience)
- 0+ years of experience in clinical science, clinical research, or equivalent (experience)
Preferred Qualifications
- MD in Pharmacology (experience)
- Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile) (experience)
Responsibilities
- Implement, plan, and execute assigned clinical trial activities
- Provide scientific and clinical leadership to a team of supporting Clinical Scientists
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
- Plan and lead the implementation of all study startup/conduct/close-out activities as applicable
- Evaluate innovative trial designs in collaboration with Medical Monitor/Clinical Development Lead
- Participate in protocol and ICF development process with minimal guidance, including writing, reviewing, adjudication/resolution of cross-functional comments and ensuring high clinical quality
- Engage in site-facing activities such as training and serving as primary contact for clinical questions
- Manage activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
- Identify clinical data trends; provide trends and escalate questions to Medical Monitor
- Develop clinical narrative plan; review clinical narratives
- Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings
- Support Study committee (e.g., DMC) activities
- Draft, review, and validate clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Collaborate and serve as primary liaison between external partners for scientific advice
Tags & Categories
Answer 10 quick questions to check your fit for Associate Director, Senior Clinical Scientist @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs