Associate Director of Clinical Science

Bristol Myers Squibb; San Diego (CA); In loco; USD 191.000 - 231.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible Time Off

11 paid holidays each year

Comprehensive benefits (medical/dental

Retirement planning

Descrizione del lavoro

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks an Associate Director of Clinical Science to support radiopharmaceutical oncology clinical development. You will collaborate across clinical development, medical writing, and operations to drive trial start-up, execution, data analysis, and regulatory submissions, with AI tools to enhance productivity.

Role involves handling IND/NDAs/MAAs, data listings and study results, and may coordinate teams or lead components of strategic

Competenze

• PharmD or PhD preferred.
• 6+ years of relevant drug development experience with an MS.
• 8+ years of relevant drug development experience with a BS degree in Biological Sciences, health care, or a related field.
• Minimum of 5 years' experience in clinical research or clinical pharmacology in a biotech/pharmaceutical company, contract research organization.

Mansioni

• Acquire and utilize knowledge of clinical trial design for study concepts and protocols.
• Participate in protocol review discussions for study design.
• Prepare study protocols, amendments, and Investigator meeting materials under guidance.
• Contribute to CRFs, Data Management Manuals, and Data Analysis Plans.
• Review ongoing clinical data and organize Data Review Committee meetings.

Conoscenze

Fast learner

Adaptable

Microsoft Office

SpotFire

FDA/EMA/ICH knowledge

Cross-functional collaboration

Formazione

PharmD or PhD preferred

MS in Biological Sciences or related field

BS in Biological Sciences or related field

Strumenti

Microsoft Office

SpotFire

Descrizione del lavoro

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio https //careers.bms.com/rayzebio/

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio https //careers.bms.com/rayzebio/

Summary

The Associate Director of Clinical Science plays a supportive role in clinical development of RayzeBio radiopharmaceuticals for oncology indications. Working in collaboration with clinical development, the position is responsible for various aspects of ongoing clinical trial program-related activities within the relevant therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start-up/execution/close out, data analysis/reporting, and potentially support of NDA/MAA filings.

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

• Acquires and utilizes knowledge of clinical trial design to develop or oversee development of specific study concept synopses and protocols.
• Participates in protocol review discussions concerning scientific and procedural aspects of study design.
• In collaboration with Medical Writing and Clinical Operations, prepares study protocols, amendments, specific sections of study manuals and Investigator meeting materials, and other documents as needed with appropriate guidance and supervision.
• Contributes to the design, development, and review of CRFs, Data Management Manuals, and Data Analysis Plans.
• Reviews ongoing clinical data.
• Organizes and oversees Data Review Committee meetings, including preparation of slides and other review and meeting materials.
• With MD supervision, addresses questions regarding scientific and related procedural issues from Investigators.
• Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
• Assists in the preparation/review of INDs, regulatory documents, IND annual report/DSURs, Investigator Brochures, and NDAs/MAAs.
• Supports priorities within functional area.
• Anticipates moderately complex obstacles within a clinical study and, with guidance, implements solutions.
• May be asked to coordinate teams and provide direction.
• May lead two or more specific components of departmental strategic initiatives.
• Able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
• Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
• May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.
• Leverage AI tools to enhance individual productivity and quality of work
• Up to 20% of travel required

Education And Experience

• PharmD or PhD preferred
• 6+ years of relevant drug development experience with a MS.
• 8+ years of relevant drug development experience with a BS degree in Biological Sciences, health care, or a related field.
• Minimum of 5 years' experience in clinical research or clinical pharmacology in a biotech/pharmaceutical company, contract research organization.

Skills And Qualifications

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Experienced with Microsoft Office (Excel, PowerPoint, etc.) as well as job-related programs such as SpotFire.
• Knowledge of FDA, EMA and ICH regulations and guidelines a must.
• Ability to effectively collaborate cross-functionally, across all levels of the organization.

Compensation Overview

Princeton - NJ - US $173,217 - $209,899 San Diego - CA - US $190,539 - $230,888

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https //careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People With Disabilities

BMS and RayzeBio are 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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only 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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https //careers.bms.com/fraud-protection.

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

R1607038 Associate Director of Clinical Science