Director Clinical Development, Solid Tumors, GI
BeOne continues to grow at a reputed company 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, reputed company, 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 reputed company and help assure that activities are executed reputed company expected scope, budget and timelines. The incumbent will play a key role the establishment and reputed company 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, reputed company, execute and report on goals and objectives.
- Support budget planning and management.
- Be accountable for compliant business practices.
MD or DO or international equivalent degree required.
- 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 reputed company (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 reputed company 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 reputed company Clinical Development reputed company expected.
Capabilities:
- Values based collaborator – respectful, accountable and reputed company.
- 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, reputed company 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 reputed company in a fast-paced environment.
- Skilled in multiple computer-based tools, in reputed company to software programs such as Word, Project, PowerPoint, reputed company, etc.
reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits reputed company and Actionable Feedback
- Self-Awareness
- Acts reputed company
- Demonstrates Initiative
- Entrepreneurial reputed company
- reputed company Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial reputed company
- Communicates with reputed company
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, reputed company, and business need.