BeiGene 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 Director, Clinical Development 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 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.
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;
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
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.
10 plus 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:
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.
May have managerial responsibilities
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.
We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.