Associate Director of Clinical Science
About The Position
The Associate Director of Clinical Science supports clinical development of RayzeBio radiopharmaceuticals for oncology indications, collaborating with clinical development and other functional teams on clinical trial program activities. The role contributes to program implementation, study start-up, execution and closeout, data analysis and reporting, and potentially NDA/MAA filings. The position develops or oversees study concept synopses and protocols; participates in protocol reviews; and collaborates with Medical Writing and Clinical Operations on protocols, amendments, study manuals, Investigator meeting materials, and other documents. It contributes to CRFs, Data Management Manuals, and Data Analysis Plans; reviews ongoing clinical data; organizes Data Review Committee meetings; and, with MD supervision, responds to Investigators’ scientific and procedural questions. The role also contributes to data listings, summary tables, study results, manuscripts, scientific presentations, and regulatory documents, including INDs, annual reports/DSURs, Investigator Brochures, and NDAs/MAAs. The Associate Director supports functional-area priorities, anticipates moderately complex study obstacles and implements solutions with guidance, may coordinate teams, and may lead components of departmental strategic initiatives. The role requires the ability to learn new therapeutic areas and use published scientific literature in study development, effective cross-functional communication, and use of AI tools to improve productivity and work quality. Up to 20% travel is required.
Requirements
- At least 5 years of experience in clinical research or clinical pharmacology at a biotechnology or pharmaceutical company, or contract research organization.
- At least 6 years of relevant drug development experience with a master's degree.
- At least 8 years of relevant drug development experience with a bachelor's degree in Biological Sciences, health care, or a related field.
- Demonstrated ability to learn quickly.
- Ability to be flexible and adaptable to change, move between projects, and provide support or expertise where needed.
- Experience with Microsoft Office, including Excel and PowerPoint, and job-related programs such as SpotFire.
- Knowledge of FDA, EMA, and ICH regulations and guidelines.
- Ability to collaborate effectively across functions and organizational levels.
- Excellent verbal, written, and interpersonal communication skills to maintain working relationships and ensure scientific integrity of clinical studies.
Nice To Haves
- PharmD or PhD.
Responsibilities
- Develop or oversee development of study concept synopses and protocols using knowledge of clinical trial design.
- Participate in protocol review discussions on scientific and procedural aspects of study design.
- Collaborate with Medical Writing and Clinical Operations to prepare protocols, amendments, study-manual sections, Investigator meeting materials, and other documents.
- Contribute to the design, development, and review of CRFs, Data Management Manuals, and Data Analysis Plans.
- Review ongoing clinical data.
- Organize and oversee Data Review Committee meetings, including preparation of slides and meeting materials.
- Address Investigators’ scientific and procedural questions with MD supervision.
- Contribute to preparation or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
- Assist with preparation or review of INDs, regulatory documents, IND annual reports/DSURs, Investigator Brochures, and NDAs/MAAs.
- Support functional-area priorities and implement solutions to moderately complex clinical-study obstacles with guidance.
- Coordinate teams and provide direction when asked; potentially lead components of departmental strategic initiatives.
- Summarize published scientific literature in new therapeutic areas and integrate it into new study development.
- Use AI tools to enhance individual productivity and quality of work.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance.
- Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
- 160 hours of paid vacation annually for eligible new hires in specified employee groups, subject to manager approval.
- 11 paid company holidays annually.
- Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
- Depending on eligibility, 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 receive an annual Global Shutdown between Christmas Day and New Year's Day.
- Potential eligibility for discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
