Clinical Development Lead Prostate (ACP3)
Bristol-Myers Squibb
Clinical Development Lead Prostate (ACP3)
Job Description
Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies 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 clinical development opportunities Oversee Data Review and Independent Data Monitoring Committees 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. Supervise and mentor clinical scientists and medical directors Willing to travel approximately 30% of the time. 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 sub-specialty training in oncology and at least 8 years of pharmaceutical/biotech in oncology solid tumor clinical development. Radiopharmaceutical experience is preferred but not required. Drug development experience in GU cancer, prostate cancer, lung cancer or other solid tumor cancers is required. 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, 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 on 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 in 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 understand the process of pharmaceutical product 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 a company focused on pharmaceutical product development and approval
- Operates in a highly regulated environment with specific guidelines and standard operating procedures (SOP's)
Key Responsibilities
- Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates
- Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies
- 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 clinical development opportunities
- Oversee Data Review and Independent Data Monitoring Committees
- 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
- Supervise and mentor clinical scientists and medical directors
Required Qualifications
- MD or equivalent with sub-specialty training in oncology
- At least 8 years of pharmaceutical/biotech experience in oncology solid tumor clinical development
- Drug development experience in GU cancer, prostate cancer, lung cancer, or other solid tumor cancers
Preferred Qualifications
- Radiopharmaceutical experience
Skills Required
- Patient-focused with 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, 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 on 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 in 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 understand the process of pharmaceutical product 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
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
Locations
- San Diego RayzeBio, Canada
- Remote United States, United States (Remote)
Salary
Estimated Salary Rangemedium confidence
150,000 - 220,000 CAD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Patient-focused with deep commitment to understanding needs and improving the lives of patients with cancersintermediate
- Passion for developing novel therapeuticsintermediate
- Motivated to work in a fast-paced, high accountability, small company environmentintermediate
- A 'can do' and collegial professional who leads through influence and interpersonal skillsintermediate
- Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detailintermediate
- Demonstrated ability to collaborate successfully with multiple functions in a team environmentintermediate
- Intellectually curious with courage to challenge and seek new ways to improve workintermediate
- 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 in 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 understand the process of pharmaceutical product 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
Required Qualifications
- MD or equivalent with sub-specialty training in oncology (experience)
- At least 8 years of pharmaceutical/biotech experience in oncology solid tumor clinical development (experience)
- Drug development experience in GU cancer, prostate cancer, lung cancer, or other solid tumor cancers (experience)
Preferred Qualifications
- Radiopharmaceutical experience (experience)
Responsibilities
- Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates
- Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies
- 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 clinical development opportunities
- Oversee Data Review and Independent Data Monitoring Committees
- 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
- Supervise and mentor clinical scientists and medical directors
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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Answer 10 quick questions to check your fit for Clinical Development Lead Prostate (ACP3) @ Bristol-Myers Squibb.
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Clinical Development Lead Prostate (ACP3)
Bristol-Myers Squibb
Clinical Development Lead Prostate (ACP3)
Job Description
Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies 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 clinical development opportunities Oversee Data Review and Independent Data Monitoring Committees 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. Supervise and mentor clinical scientists and medical directors Willing to travel approximately 30% of the time. 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 sub-specialty training in oncology and at least 8 years of pharmaceutical/biotech in oncology solid tumor clinical development. Radiopharmaceutical experience is preferred but not required. Drug development experience in GU cancer, prostate cancer, lung cancer or other solid tumor cancers is required. 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, 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 on 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 in 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 understand the process of pharmaceutical product 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 a company focused on pharmaceutical product development and approval
- Operates in a highly regulated environment with specific guidelines and standard operating procedures (SOP's)
Key Responsibilities
- Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates
- Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies
- 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 clinical development opportunities
- Oversee Data Review and Independent Data Monitoring Committees
- 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
- Supervise and mentor clinical scientists and medical directors
Required Qualifications
- MD or equivalent with sub-specialty training in oncology
- At least 8 years of pharmaceutical/biotech experience in oncology solid tumor clinical development
- Drug development experience in GU cancer, prostate cancer, lung cancer, or other solid tumor cancers
Preferred Qualifications
- Radiopharmaceutical experience
Skills Required
- Patient-focused with 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, 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 on 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 in 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 understand the process of pharmaceutical product 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
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
Locations
- San Diego RayzeBio, Canada
- Remote United States, United States (Remote)
Salary
Estimated Salary Rangemedium confidence
150,000 - 220,000 CAD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Patient-focused with deep commitment to understanding needs and improving the lives of patients with cancersintermediate
- Passion for developing novel therapeuticsintermediate
- Motivated to work in a fast-paced, high accountability, small company environmentintermediate
- A 'can do' and collegial professional who leads through influence and interpersonal skillsintermediate
- Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detailintermediate
- Demonstrated ability to collaborate successfully with multiple functions in a team environmentintermediate
- Intellectually curious with courage to challenge and seek new ways to improve workintermediate
- 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 in 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 understand the process of pharmaceutical product 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
Required Qualifications
- MD or equivalent with sub-specialty training in oncology (experience)
- At least 8 years of pharmaceutical/biotech experience in oncology solid tumor clinical development (experience)
- Drug development experience in GU cancer, prostate cancer, lung cancer, or other solid tumor cancers (experience)
Preferred Qualifications
- Radiopharmaceutical experience (experience)
Responsibilities
- Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates
- Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies
- 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 clinical development opportunities
- Oversee Data Review and Independent Data Monitoring Committees
- 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
- Supervise and mentor clinical scientists and medical directors
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 Clinical Development Lead Prostate (ACP3) @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs