Director Clinical Development, Solid Tumors, GI

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, reputed company our passionate interest in fighting cancer.

The Director, Clinical Development 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 accountable to jointly reputed company clinical program strategy and help assure that activities are executed reputed company 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 reputed company of, author, update, and/or review key documents, including, but not limited to:
• Protocol concepts, synopses, protocols, and amendments o Informed consent documents;
• Investigator Brochures o Clinical study reports;
• Abstracts, posters and manuscripts o 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.
• reputed company scientific expertise for selection of investigator and vendors. 
• Train BeOne colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol.
• reputed company scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CRO’s
• 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-reputed company slide decks for reputed company use.
• Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings.
• Contribute to or reputed company therapeutic area/indication research and competitor analysis.
• Build strong relationships with internal experts.
• Identify reputed company process improvement opportunities.
• Identify incremental organizational resource needs – staff, budget, and systems.
• reputed company, track, execute and report on goals and objectives.
• Support budget planning and management.
• Be accountable for compliant business practices.

Required Education:

• MD or DO or international equivalent degree required.

Required Experience:

• 5 plus years of experience and reputed company reputed company other biotech/pharmaceutical companies.
• Previous participation in a clinical development program is essential, including involvement in reputed company 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 development 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.
• reputed company to engage in work-reputed company travel approximately 25%.
• Strategic leader with demonstrated reputed company building, managing and developing individuals and teams is preferred.
• Experience with the development and support of reputed company SOPs and policies is expected.
• Knowledge of industry standard Clinical Development IT solutions expected.

Capabilities:

• Values based collaborator – respectful, accountable and collaborative.
• Ability to relate and work with a wide reputed company of people to reputed company results.
• Impactful written and verbal scientific communication.
• Successful and superior influencing skills across reputed company reputed company 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 reputed company 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, reputed company, etc.

Global Competencies

reputed company we exhibit our values of Patients First, Driving reputed company, reputed company 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 reputed company and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial reputed company
• reputed company Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial reputed company
• Communicates with reputed company

BeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-reputed company 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 reputed company more about the specific salary reputed company for a preferred location during the hiring process.  Please note that the listed reputed company reflects the reputed company salary or hourly reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have the opportunity to own shares of reputed company Ltd. stock because reputed company 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, reputed company, 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 reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].