Consulting Director – Medical Surgical
Vizient, Inc
Senior Director, Clinical Development – Breast Cancer
BeOne Medicines
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteSalary
💰 $287,500 - $357,500 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- BeOne Senior Director, Clinical Development, Breast Cancer role to support clinical and medical assets by execution of clinical development programs; work across organization and external partners Involved in clinical program strategy and ensure activities executed within scope, budget and timelines Establish and grow Clinical Research functions for global capabilities and execution Collaborate with clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research Generate, author, update, and review key documents: protocols, informed consents, IBs, CSRs, abstracts, posters, manuscripts, IND/NDA clinical sections, DSURs, HA Briefing Documents, Orphan Drug applications Partner with clinical operations for implementation and execution of clinical studies Provide scientific expertise for investigator and vendor selection; train colleagues, CROs, and site staff Provide medical support during trials; respond to sites, IRBs/IECs, Health Authorities, and CROs Review, query, analyze clinical trial data; interpret and present data internally and externally Represent clinical study/program on internal teams; build opinion leader networks; organize advisory boards and investigator meetings Contribute to therapeutic area research and competitor analysis; identify process improvements and resource needs Develop, track, execute and report on goals; support budget planning and compliant business practices
Requirements
- 6 plus years of experience within other biotech/pharmaceutical or relevant academic credentials companies Advanced degree (MD or MD equivalent) with subspecialty training in oncology (preferred) Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials Ideally having taken at least one study through from start to finish in a clinical scientist role Clinical oncology experience; candidates with exceptional experience in other therapeutic areas would be considered Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills Knowledge of GCP and ICH Guidelines Flexibility to work with colleagues in a global setting Able to engage in work-related travel approximately 25% Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred Experience with the development and support of related SOPs and policies is expected Knowledge of industry standard Clinical Development IT solutions expected
