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Executive Director, Clinical Science, Hematology
- BeOne Medicines (Emeryville, CA)
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The Executive Director, Clinical Science 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 accountable to jointly develop clinical program strategy with the medical directors and help assure that activities are executed within expected scope and timelines. The incumbent will play a key role the establishment and growth of Clinical Research functions as it relates to clinical science 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
+ Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
Capabilities** **and** **Competencies:
+ Executive presence
+ Values based collaborator - respectful, accountable and collaborative
+ Ability to relate and work with a wide range of people to achieve results
+ Effective written and verbal scientific communication
+ Successful and superior influencing skills across all levels of the organization and external collaborators
+ Problem solving and risk-mitigation skills
+ Confident, positive attitude
+ Appreciation of diversity and multiculturalism
+ Strategic and creative thinker
+ Ability to build working relations throughout the organization and with business partners to achieve business goals
+ Strong time management and organizational skills
+ Ability to manage multiple projects in a fast-pacedenvironment
+ Skilled in multiple computer-based tools, in addition to software programs such as MS Office
+ Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values
+ Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction
+ Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information
+ Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed and contributes to building a positive team spirit; Shares expertise with others
+ Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events
+ Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others
+ Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan
+ Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality
+ Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data
+ Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully
+ Project Management - Communicates changes and progress; Completes projects on time and budget
Supervisory** **Responsibilities** **:
+ Guide junior colleagues in clinical science
+ Mentor reports to fulfill their potential
Requ** **irements:
+ PharmD or PhD within clinical and/or scientific profession (or an equivalent level of professional clinical and/or scientific education, training and experience) required
+ 8 plus years of relevant experience
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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