Director, Clinical Science

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. General Description

The 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. The candidate will report to the Senior Director, Clinical Development. As a leader in the organization, the incumbent will be accountable to jointly develop clinical program strategy and help assure that activities are executed within expected scope, budget and timelines.

The incumbent will play a key role 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.

• MD, Pharm
  
  D. or PhD. within a clinical and/or scientific profession with 5+ years of professional or clinical experience within other biotech/pharmaceutical companies required.

• Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report), 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 if they demonstrated clear potential to apply their existing skills to oncology.

• 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.

• Executive presence.

• Values based collaborator – respectful, accountable and collaborative.

• Ability to relate and work with a wide range of people to achieve results.

• Impactful 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, enthusiastic and charismatic.

• 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‑paced environment.

• Skilled in multiple computer‑based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.

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…