Job Information
Bristol Myers Squibb Sr. Medical Director, Clinical Development in Remote, United States
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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 rich in diversity. Take your career farther than you thought possible.
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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 .
The Senior Medical Director - Clinical Development has responsibility for clinical development of targeted radiopharmaceuticals for treatment of solid tumors. Responsibilities may include support for IND preparation, regulatory authority interactions, design and execution of Phase 1 to Phase 3 clinical trials, and medical monitoring. This role provides medical direction and high quality scientific and clinical knowledge to guide the strategy and execution of RayzeBio's clinical development plan. This role works collaboratively with multi-disciplinary teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBio's portfolio to ensure the program meets the needs of patients and RayzeBio's business.
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.
Willing to travel approximately 25% of the time. Evening and weekend work will be involved.
Education and Experience:
MD or equivalent with at least 5 years of pharmaceutical or biotech experience in oncology solid tumor clinical development.
Radiopharmaceutical experience is preferred but not required.
Early development experience and experience in breast cancer clinical development highly desired
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" 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.
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.
The starting compensation for this job is a range from $297,878-$403,011 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
#RayzeBio
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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Company: Bristol-Myers Squibb
Req Number: R1587830
Updated: 2024-11-30 05:20:19.286 UTC
Location: Remote
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.