Medical Director, Radiopharmaceutical Imaging (RPI)
Bristol-Myers Squibb
Medical Director, Radiopharmaceutical Imaging (RPI)
Job Description
Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents. Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets Translate findings from research and nonclinical studies into diagnostic imaging development opportunities Oversee Data Review and Independent Data Monitoring Committees as applicable Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines Establish and maintain positive relationships with clinical trial investigators and thought leaders Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings. Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging. Willing to travel approximately 30% of the time. Evening and weekend work will be involved. 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. MD or equivalent with at least 5 years of pharmaceutical, biotech experience or academic clinical experience in oncology diagnostic development or 3 years' experience for candidates with track record of developing radiopharmaceutical imaging agents through a regulatory process. Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics Motivated to work in a fast-paced, high accountability, and small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills. Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering deadlines with high performance standards and attention to detail. Demonstrated ability to collaborate successfully with multiple functions in a team environment. Intellectually curious with courage to challenge and seek new ways to improve work. Strong written and oral communication skills, including presentation skills. Ability to analyze and interpret data and develop written reports and presentations of those data. Strong critical, strategic, and analytical thinking skills. Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reporting. Experience working closely with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical trials. Skilled in clinical research and understands the process of radiopharmaceutical imaging agent development and approval. Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP's). Solid understanding of GCP and ICH guidelines.
About the Role/Company
- RayzeBio is focused on developing a diagnostic imaging program for their portfolio in radiopharmaceutical imaging
Key Responsibilities
- Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates
- Lead internal project teams and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents
- Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents
- Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators
- Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
- Translate findings from research and nonclinical studies into diagnostic imaging development opportunities
- Oversee Data Review and Independent Data Monitoring Committees as applicable
- Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
- Establish and maintain positive relationships with clinical trial investigators and thought leaders
- Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings
- Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging
Required Qualifications
- MD or equivalent degree
- At least 5 years of pharmaceutical, biotech, or academic clinical experience in oncology diagnostic development
- years' experience for candidates with a track record of developing radiopharmaceutical imaging agents through a regulatory process
Preferred Qualifications
- Patient-focused with a deep commitment to understanding needs and improving the lives of patients with cancers
- Passion for developing novel therapeutics
- Motivated to work in a fast-paced, high accountability, and small company environment
- Demonstrated record of accomplishment in a compressed time frame
- Capable of prioritizing tasks and delivering deadlines with high performance standards and attention to detail
- Demonstrated ability to collaborate successfully with multiple functions in a team environment
- Intellectually curious with courage to challenge and seek new ways to improve work
Skills Required
- Strong written and oral communication skills, including presentation skills
- Ability to analyze and interpret data and develop written reports and presentations of those data
- Strong critical, strategic, and analytical thinking skills
- Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reporting
- Experience working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trials
- Skilled in clinical research and understands the process of radiopharmaceutical imaging agent development and approval
- Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP's)
- Solid understanding of GCP and ICH guidelines
- A 'can do' and collegial professional who leads through influence and interpersonal skills
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
- Willing to travel approximately 30% of the time
- Evening and weekend work will be involved
Locations
- San Diego CA, United States
Salary
Estimated Salary Rangemedium confidence
250,000 - 400,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong written and oral communication skills, including presentation skillsintermediate
- Ability to analyze and interpret data and develop written reports and presentations of those dataintermediate
- Strong critical, strategic, and analytical thinking skillsintermediate
- Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reportingintermediate
- Experience working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trialsintermediate
- Skilled in clinical research and understands the process of radiopharmaceutical imaging agent development and approvalintermediate
- Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP's)intermediate
- Solid understanding of GCP and ICH guidelinesintermediate
- A 'can do' and collegial professional who leads through influence and interpersonal skillsintermediate
Required Qualifications
- MD or equivalent degree (experience)
- At least 5 years of pharmaceutical, biotech, or academic clinical experience in oncology diagnostic development (experience)
- years' experience for candidates with a track record of developing radiopharmaceutical imaging agents through a regulatory process (experience)
Preferred Qualifications
- Patient-focused with a deep commitment to understanding needs and improving the lives of patients with cancers (experience)
- Passion for developing novel therapeutics (experience)
- Motivated to work in a fast-paced, high accountability, and small company environment (experience)
- Demonstrated record of accomplishment in a compressed time frame (experience)
- Capable of prioritizing tasks and delivering deadlines with high performance standards and attention to detail (experience)
- Demonstrated ability to collaborate successfully with multiple functions in a team environment (experience)
- Intellectually curious with courage to challenge and seek new ways to improve work (experience)
Responsibilities
- Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates
- Lead internal project teams and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents
- Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents
- Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators
- Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
- Translate findings from research and nonclinical studies into diagnostic imaging development opportunities
- Oversee Data Review and Independent Data Monitoring Committees as applicable
- Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
- Establish and maintain positive relationships with clinical trial investigators and thought leaders
- Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings
- Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging
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
Travel Requirements
0%
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Medical Director, Radiopharmaceutical Imaging (RPI)
Bristol-Myers Squibb
Medical Director, Radiopharmaceutical Imaging (RPI)
Job Description
Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents. Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets Translate findings from research and nonclinical studies into diagnostic imaging development opportunities Oversee Data Review and Independent Data Monitoring Committees as applicable Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines Establish and maintain positive relationships with clinical trial investigators and thought leaders Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings. Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging. Willing to travel approximately 30% of the time. Evening and weekend work will be involved. 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. MD or equivalent with at least 5 years of pharmaceutical, biotech experience or academic clinical experience in oncology diagnostic development or 3 years' experience for candidates with track record of developing radiopharmaceutical imaging agents through a regulatory process. Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics Motivated to work in a fast-paced, high accountability, and small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills. Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering deadlines with high performance standards and attention to detail. Demonstrated ability to collaborate successfully with multiple functions in a team environment. Intellectually curious with courage to challenge and seek new ways to improve work. Strong written and oral communication skills, including presentation skills. Ability to analyze and interpret data and develop written reports and presentations of those data. Strong critical, strategic, and analytical thinking skills. Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reporting. Experience working closely with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical trials. Skilled in clinical research and understands the process of radiopharmaceutical imaging agent development and approval. Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP's). Solid understanding of GCP and ICH guidelines.
About the Role/Company
- RayzeBio is focused on developing a diagnostic imaging program for their portfolio in radiopharmaceutical imaging
Key Responsibilities
- Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates
- Lead internal project teams and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents
- Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents
- Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators
- Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
- Translate findings from research and nonclinical studies into diagnostic imaging development opportunities
- Oversee Data Review and Independent Data Monitoring Committees as applicable
- Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
- Establish and maintain positive relationships with clinical trial investigators and thought leaders
- Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings
- Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging
Required Qualifications
- MD or equivalent degree
- At least 5 years of pharmaceutical, biotech, or academic clinical experience in oncology diagnostic development
- years' experience for candidates with a track record of developing radiopharmaceutical imaging agents through a regulatory process
Preferred Qualifications
- Patient-focused with a deep commitment to understanding needs and improving the lives of patients with cancers
- Passion for developing novel therapeutics
- Motivated to work in a fast-paced, high accountability, and small company environment
- Demonstrated record of accomplishment in a compressed time frame
- Capable of prioritizing tasks and delivering deadlines with high performance standards and attention to detail
- Demonstrated ability to collaborate successfully with multiple functions in a team environment
- Intellectually curious with courage to challenge and seek new ways to improve work
Skills Required
- Strong written and oral communication skills, including presentation skills
- Ability to analyze and interpret data and develop written reports and presentations of those data
- Strong critical, strategic, and analytical thinking skills
- Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reporting
- Experience working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trials
- Skilled in clinical research and understands the process of radiopharmaceutical imaging agent development and approval
- Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP's)
- Solid understanding of GCP and ICH guidelines
- A 'can do' and collegial professional who leads through influence and interpersonal skills
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
- Willing to travel approximately 30% of the time
- Evening and weekend work will be involved
Locations
- San Diego CA, United States
Salary
Estimated Salary Rangemedium confidence
250,000 - 400,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong written and oral communication skills, including presentation skillsintermediate
- Ability to analyze and interpret data and develop written reports and presentations of those dataintermediate
- Strong critical, strategic, and analytical thinking skillsintermediate
- Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reportingintermediate
- Experience working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trialsintermediate
- Skilled in clinical research and understands the process of radiopharmaceutical imaging agent development and approvalintermediate
- Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP's)intermediate
- Solid understanding of GCP and ICH guidelinesintermediate
- A 'can do' and collegial professional who leads through influence and interpersonal skillsintermediate
Required Qualifications
- MD or equivalent degree (experience)
- At least 5 years of pharmaceutical, biotech, or academic clinical experience in oncology diagnostic development (experience)
- years' experience for candidates with a track record of developing radiopharmaceutical imaging agents through a regulatory process (experience)
Preferred Qualifications
- Patient-focused with a deep commitment to understanding needs and improving the lives of patients with cancers (experience)
- Passion for developing novel therapeutics (experience)
- Motivated to work in a fast-paced, high accountability, and small company environment (experience)
- Demonstrated record of accomplishment in a compressed time frame (experience)
- Capable of prioritizing tasks and delivering deadlines with high performance standards and attention to detail (experience)
- Demonstrated ability to collaborate successfully with multiple functions in a team environment (experience)
- Intellectually curious with courage to challenge and seek new ways to improve work (experience)
Responsibilities
- Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates
- Lead internal project teams and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents
- Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents
- Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators
- Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
- Translate findings from research and nonclinical studies into diagnostic imaging development opportunities
- Oversee Data Review and Independent Data Monitoring Committees as applicable
- Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
- Establish and maintain positive relationships with clinical trial investigators and thought leaders
- Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings
- Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging
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
Travel Requirements
0%
Tags & Categories
Answer 10 quick questions to check your fit for Medical Director, Radiopharmaceutical Imaging (RPI) @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs