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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 Director - Clinical Pharmacology will be a key member of the development team, developing clinical pharmacology strategy, leading the design, execution, interpretation and reporting of clinical pharmacology data, and serve as clinical pharmacology lead on studies and project teams. The role will support projects at various stages of development, playing an active role in our drug discovery and development efforts to advance RayzeBio's radiopharmaceutical pipeline.

Job Responsibilities:

Essential duties and responsibilities include the following. Other duties may be assigned.

• Develop clinical pharmacology strategy and related clinical development plan consistent with the development strategy, program goals, and the US/international regulatory guidance for radiopharmaceuticals.

• Collaborate with DMPK, clinical development, and CMC teams to define clinical pharmacology data needed to support NDA and drug label.

• Determine scope, design, plan, analyze and interpret pharmacokinetic and pharmacodynamics (PK/PD) in company-sponsored studies, including development of appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from concept stage to commercialization.

• Provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Development, Biometrics, and Regulatory Affairs.

• Contribute to the design and execution of Phase 1 clinical pharmacology (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, and thorough QT, etc.) and dosimetry studies.

• Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial documents.

• Plan, prepare, and review clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.), participate in drafting publications and making scientific presentations consistent with development strategies.

• Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to ensure integration of clinical pharmacology principles into project plans and study design.

• Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities.

• Other duties as assigned.

• Willing to travel up to approximately 10% of the time (if not based in San Diego area).

Education and Experience:

• PhD, MD or PharmD with at least 8-10 years of pharmaceutical or biotech experience in clinical pharmacology and oncology drug development.

• Experience with early and late-stage clinical development, IND and filing dossier

• Radiopharmaceutical experience is preferred but not 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" 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.

• Strong background and expertise in Clinical Pharmacology, PK and PK/PD demonstrated by major Regulatory submission experience and/or scientific publications.

• Proven ability to manage strategic, scientific and operational aspects of development projects from a Clinical Pharmacology perspective.

• 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 $234,726-$317,571 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.

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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/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1587828

Updated: 2024-12-04 02:20:04.694 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.