Clinical Research Scientist - Breast Cancer Franchise

Role Summary

Development Clinical Research Scientist in the Breast Cancer Franchise focused on late phase assets, responsible for the design, execution, and analysis of clinical trials to support development of innovative breast cancer therapies. Ensure medical activities align with medical vision and regulatory requirements, and contribute to regulatory submissions and external engagements. Demonstrate leadership in clinical development and provide mentoring and clear written communication for external data disclosures and regulatory documentation.

Responsibilities

• Contribute to the development and execution of clinical strategies for breast cancer programs, balancing accelerated timelines with quality.
• Ensure compliance with procedures and hold team members accountable for compliance.
• Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
• Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management.
• Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence.
• Collaborate with Global Patient Safety on risk management planning.
• Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions.
• Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training.
• Participate in data analysis, scientific dissemination, and preparation of final study reports.
• Analyze and contextualize clinical data to support decision-making and portfolio strategy.
• Contribute to strategic planning and innovation through cross-functional working groups.
• Support planning and execution of symposia, advisory boards, and other external engagements.
• Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts.
• Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions.

Qualifications

• PhD with 3+ years of industry experience or BS in a health-related field with 10+ years of industry experience.
• 3+ years of clinical research scientist experience/clinical trial experience.
• Direct line leadership experience.
• Breast cancer disease state knowledge/experience (preferred).

Skills

• Strong scientific communication, interpersonal, teamwork, organizational, and negotiation skills.
• Ability to influence cross-functional teams to foster a positive working environment.
• Excellent written and verbal English communication.

Education

• Advanced health/medical/scientific degree (e.g., PharmD, PhD, MSN with advanced clinical specialty such as Clinical Nurse Specialist/Nurse Practitioner) (preferred).

Additional Requirements

• Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission.
• Domestic and international travel as needed to support business needs.