Department: Global Clinical Development
Reports To: SVP, Global Clinical Development
MD, PharmD. or PhD. within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
Hours: 40 hours/week
Over-time may be required on occasion
The Director – Clinical Science will support BeiGene 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 SVP of Global Clinical Development who, in turn, reports to a Chief Medical Officer.
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.
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 BeiGene 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.
- Minimum of 7 – 10 years of experience and success within other biotech/pharmaceutical companies.
- 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.
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.
- 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.
Location: San Francisco Bay Area
Travel: Work related travel approximately 25%
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. 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.
Computer Skills : Efficient in Microsoft Word, Excel, and Outlook
Other Qualifications :