Job description
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 Senior 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.
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:
6 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) and Breast Cancer experience a plus
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: $299,800.00 - $369,800.00 annuallyBeOne 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 BeOne Medicines 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. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .
Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.