Senior Director, Clinical Development, Solid Tumors

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.

General Description

The Senior Director, Clinical Development, Solid Tumors 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 Vice President, Clinical Development.

As a leader in the organization, the incumbent will be involved 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

• Identify continuous process improvement opportunities.
• Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
• Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
• Be accountable for compliant business practices.
• Review, query, and analyze clinical trial data
• Support budget planning and management.
• Develop, track, execute and report on goals and objectives.
• Facilitate generation of, author, update, and/or review key documents, including, but not limited to:
• Interpret, and present clinical trial data both internally and externally
• Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports
• Build strong relationships with internal experts.
• Investigator Brochures
• Contribute to or perform therapeutic area/indication research and competitor analysis
• Abstracts, posters and manuscripts
• Train BeiGene colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol
• Informed consent documents
• Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs
• Risks / benefits analysis for applicable documents
• Clinical study reports
• Clinical Development Plans
• Create clinical study or program-related slide decks for internal and external use
• Represent a clinical study or development program on one or more teams or subteams
• Protocol concepts, synopses, protocols, and amendments
• Identify incremental organizational resource needs – staff, budget, and systems.
• Provide scientific expertise for selection of investigator and vendors
• Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings

Education Required

• MD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.

Required Experience

• 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.
• Able to engage in work-related travel approximately 25%
• Flexibility to work with colleagues in a global setting.
• Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing.
• Experience with the development and support of related SOPs and policies is expected.
• Knowledge of GCP and ICH Guidelines.
• 8 plus years of experience within other biotech/pharmaceutical or relevant academic credentials companies.
• Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred.
• 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.
• Advanced degree (MD or MD equivalent) with subspecialty training in oncology (preferred).
• High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
• Knowledge of industry standard Clinical Development IT solutions expected.

Capabilities And Competencies

• Strong time management and organizational skills.
• Appreciation of diversity and multiculturalism.
• Executive presence.
• Successful and superior influencing skills across all levels of the organization and external collaborators.
• Ability to relate and work with a wide range of people to achieve results.
• Skilled in multiple computer-based tools, in addition to software programs such as MS Office.
• Ability to build working relations throughout the organization and with business partners to achieve business goals.
• Impactful written and verbal scientific communication.
• Ability to manage multiple projects in a fast paced environment.
• Strategic and creative thinker.
• Values based collaborator – respectful, accountable and collaborative.
• Problem solving and risk-mitigation skills.
• Confident, positive attitude, enthusiastic and charismatic.

Supervisory Responsibilities

• Yes

Competencies

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.

Salary Range: $273,400.00 - $343,400.00 annually

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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.