Veterans Staffing
Senior Medical Director - Clinical Development
Veterans Staffing, Washington, District of Columbia, us, 20022
Senior Medical Director - Clinical Development
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned: 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 junior medical directors as required Willing to travel approximately 30% of the time both domestic and international. Evening and weekend work will be involved. Education and Experience
MD or equivalent with at least 5 years of pharmaceutical or biotech experience (8+ for Exec. Medical Director) in oncology solid tumor clinical development. Radiopharmaceutical experience is preferred but not required. Experience in oncology drug development or sub-specialty training in oncology required. Skills and Qualifications
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" professional who leads through influence and excellent interpersonal skills. Demonstrated ability to collaborate successfully with multiple functions in a matrix team environment. Intellectually curious with courage to challenge and seek new ways to improve work. Strong written and oral communication skills, including presentation skills. 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. 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. Physical Demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision. Work Environment
The noise level in the work environment is usually moderate.
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned: 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 junior medical directors as required Willing to travel approximately 30% of the time both domestic and international. Evening and weekend work will be involved. Education and Experience
MD or equivalent with at least 5 years of pharmaceutical or biotech experience (8+ for Exec. Medical Director) in oncology solid tumor clinical development. Radiopharmaceutical experience is preferred but not required. Experience in oncology drug development or sub-specialty training in oncology required. Skills and Qualifications
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" professional who leads through influence and excellent interpersonal skills. Demonstrated ability to collaborate successfully with multiple functions in a matrix team environment. Intellectually curious with courage to challenge and seek new ways to improve work. Strong written and oral communication skills, including presentation skills. 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. 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. Physical Demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision. Work Environment
The noise level in the work environment is usually moderate.