Clinical Development Lead Prostate (ACP3)

Bristol Myers Squibb•San Diego, CA

6d•$306,814 - $401,529•Remote

About The Position

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. Read more: careers.bms.com/working-with-us . Clinical 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 RayzeBio’s 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 RayzeBio’s portfolio to ensure the program meets the needs of patients and RayzeBio’s business.

Requirements

MD or equivalent with sub-specialty training in oncology and at least 8 years of pharmaceutical/biotech in oncology solid tumor clinical development.
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.

Nice To Haves

Radiopharmaceutical experience is preferred but not required.

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
Willing to travel approximately 30% of the time.

Benefits

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.
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
Eligibility Disclosure: T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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