Senior Director, Clinical Development, Breast Cancer

Senior Director, Clinical Development, Solid Tumors

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

The Senior Director, Clinical Development, Solid Tumors will support BeOne Clinical and Medical assets by successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. As a leader in the organization, the incumbent will be involved in clinical program strategy and help assure that activities are executed within expected scope, budget and timelines. The incumbent will play a key role in the establishment and growth of Clinical Research functions to assure best-in-class global capabilities and execution. Specifically, the incumbent will work closely with colleagues in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance, regulatory, molecular diagnostics, and translational research.

Essential Functions of the Job :

• Facilitate generation of, author, update, and / or review key documents, including, but not limited to :
• Protocol concepts, synopses, protocols, and amendments
• Informed consent documents
• Investigator Brochures
• Clinical study reports
• Abstracts, posters and manuscripts
• Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
• Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports
• Risks / benefits analysis for applicable documents
• Clinical Development Plans
• Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
• Provide scientific expertise for selection of investigator and vendors
• Train BeOne colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and / or clinical protocol
• Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs / IECs, Health Authorities, and CROs
• Review, query, and analyze clinical trial data
• Interpret, and present clinical trial data both internally and externally
• Represent a clinical study or development program on one or more teams or sub teams
• Create clinical study or program-related slide decks for internal and external use
• Build and maintain opinion leader / investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
• Contribute to or perform therapeutic area / indication research and competitor analysis
• Build strong relationships with internal experts
• Identify continuous process improvement opportunities
• Identify incremental organizational resource needs staff, budget, and systems
• Develop, track, execute and report on goals and objectives
• Support budget planning and management
• Be accountable for compliant business practices

Required Experience :

Global Competencies :

Salary Range : $287,500.00 - $357,500.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA / HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.