Contribute to the development and execution of clinical strategies for breast cancer programs.
Maintain a focus on accelerating timelines while ensuring quality.
Demonstrate compliance with procedures and be accountable for compliance of team members.
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.
Requirements
PhD with 3+ years of industry experience OR BS Degree or equivalent experience in Health-related field with 10+ years’ industry experience
3+ years of clinical research scientist experience/clinical trial experience
Direct Line Leadership experience
Breast cancer disease state knowledge/experience
An advanced health/medical/scientific graduate degree such as PharmD, PhD, MSN with advanced clinical specialty
Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission.
Proven strong communication, interpersonal, teamwork, organizational, and negotiation skills
Demonstrated ability to influence others
Benefits
Medical, dental, vision, and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care)
Life insurance and death benefits
Vacation benefits
Employee assistance program
Fitness benefits
Employee clubs and activities
Company-sponsored 401(k)
Pension
Job title
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