Director Clinical Development, Solid Tumors

BeiGene, Ltd.; United States; Remote; USD 239,000 - 300,000; Full time

Job summary

An established industry player is seeking a Director of Clinical Development for Solid Tumors to lead clinical programs and ensure best-in-class execution. This role involves strategic oversight, collaboration with internal teams and external partners, and the generation of critical clinical documents. The ideal candidate will possess extensive oncology experience and a proven track record in clinical development. Join a forward-thinking organization dedicated to advancing cancer treatment and making a significant impact in patients' lives. This is an exciting opportunity to contribute to innovative clinical strategies in a dynamic environment.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Time Off

Wellness Programs

Employee Stock Purchase Plan

Discretionary Equity Awards

Qualifications

• 5+ years of experience in biotech/pharmaceutical or relevant academic credentials.
• Advanced degree in oncology preferred, with clinical trial experience.
• Expert understanding of global clinical study design.

Responsibilities

• Lead clinical program strategy and execution within budget and timelines.
• Facilitate generation and review of key clinical documents.
• Provide scientific expertise and support throughout clinical trials.

Skills

Clinical Development

Oncology Expertise

Communication Skills

Project Management

Interpersonal Skills

Analytical Thinking

Education

Advanced Degree (MD or equivalent)

Tools

Clinical Development IT Solutions

Job description

Director Clinical Development, Solid Tumors

Director Clinical Development, Solid Tumors

Apply locations Remote (US) time type Full time posted on Posted 13 Days Ago job requisition id R26013

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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.

The Director, Clinical Development, 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. The candidate will report to the Vice President, Clinical Development.

As a leader in the organization, the incumbent will be involved in 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
• 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 sub teams
• 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 Experience:

• 5 plus years of experience within other biotech/pharmaceutical or relevant academic credentials companies
• Advanced degree (MD or MD equivalent) with subspecialty training in oncology (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
• 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

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $239,600.00 - $299,600.00 annually

BeOne 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. BeOne 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.