Sr. Medical Director, Clinical Development

About the job Sr. Medical Director, Clinical Development Job Title: Sr. Medical Director, Clinical Development Job Location: United States Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Director Working with UsChallenging. 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.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. Read more working-with-us .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 ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be teract with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidatesLead internal project teams, and partner with investigators and CROs to design and implement clinical studiesContribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documentsConduct investigator meetings and lead site qualification and initiation visits with clinical trial investigatorsExecute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgetsTranslate findings from research and nonclinical studies into clinical development opportunitiesOversee Data Review and Independent Data Monitoring CommitteesConduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelinesEstablish and maintain positive relationships with clinical trial investigators and thought leadersServe 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 ExperienceMD 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 desiredSkills and QualificationsPatient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeuticsMotivated 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 tellectually 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 DemandsWhile 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 andor move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.Work EnvironmentThe 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.#RayzeBioIf 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 CareersWith a single vision as inspiring as Transforming patients' lives through scienceâ„¢ , 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 ProtocolBMS 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 roleSite-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 accommodationsadjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodationadjustment prior to accepting a job offer. If you require reasonable accommodationsadjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit 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 california-residentsAny data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.

Created: 2025-01-10