Associate Director, Clinical Development

General Description

The Associate Director, Clinical Development for 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 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 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.

Additional Responsibilities

• 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 subteams.
• 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 Education

• MD, DO, PhD, PharmD or equivalent international degree required.

Required Experience

• 4+ plus years of clinical research experience within biotech/pharma or within an equivalent academic environment.
• 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.
• 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.
• Experience with the development and support of related SOPs and policies is expected.

Computer Skills

• Efficient in Microsoft Word, Excel, and Outlook

Travel

• Work related travel approximately 15%