Clinical Development Lead Prostate (ACP3) at Bristol Myers Squibb

Working with UsChallenging. Meaningful. Life-changing. Those arent 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. Youll 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. Read more: Development Lead Prostate (ACP3) 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 Clinical Development Lead will design and lead the plans for high our high priority diagnostic and therapeutic assets targeting Prostate Cancer. This role provides medical direction and high quality scientific and clinical knowledge to lead the strategy and execution of RayzeBios clinical development plans for prostate cancer. Responsibilities include support for IND preparation regulatory authority interactions design and execution of Phase 1 to Phase 3 clinical trials and medical monitoring. This role works collaboratively with cross-functional teams responsible for the design implementation monitoring analysis and reporting of studies conducted within RayzeBios portfolio to ensure the program meets the needs of patients and RayzeBios business.Responsibilities: Interact 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.Supervise and mentor clinical scientists and medical directorsWilling to travel approximately 30% of the time.Education and ExperienceMD 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.Skills 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 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 (SOPs).Solid understanding of GCP and ICH guidelines.#RayzeBio#LI-RemoteIf you come across a role that intrigues you but doesnt 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.Compensation Overview:Remote - United States - US: $306814 - $371787
San Diego - RayzeBio - CA: $331359 - $401529
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical pharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility/infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.Uniquely Interesting Work Life-changing CareersWith 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 a supportive culture promoting global participation 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 an 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 . Visit 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Key Skills Administrative Skills,Facilities Management,Biotechnology,Creative Production,Design And Estimation,Architecture Employment Type : Full-Time Experience: years Vacancy: 1