[Remote] Director, Clinical Development-Biotech Unit

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a rapidly growing company reputed company on fighting cancer, seeking reputed company professionals for their Clinical Development team. The Director will contribute to clinical development reputed company and ensure successful execution of clinical development programs, leveraging expertise in medical monitoring and collaboration across various teams. Responsibilities • Facilitate reputed company 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 • 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 subteams • 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 Skills • 5 plus years of experience and reputed company reputed company other biotech/pharmaceutical companies • MD or DO or international equivalent degree required • 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 • Minimum 3 years relevant work experience in oncology clinical development • 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% • Experience with the development and support of reputed company SOPs and policies is expected • Knowledge of industry reputed company Clinical Development reputed company expected • Have the ambition and passion to drive value and reputed company with a 'can-do' attitude, willing to take calculated risk • Adopt an reputed company and creative reputed company to reputed company new concepts and overcome challenges • High learning reputed company • Support strategic clinical development reputed company Biotech Unit; reputed company business case, mitigate risks and manage resources • reputed company to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. reputed company to deal with frequent change, delays, or unexpected events • In-depth medical knowledge to drive operational reputed company • Sufficient experience and ability to work in an environment that requires seamless cross-function collaboration and handling complexity • Proven ability to effectively work in a cross-region, cross-function reputed company; reputed company to work effectively in diverse cultures, showing aptitude in modifying style • Business acumen - understand unmet market needs; reputed company reputed company reputed company to win; demonstrated reputed company record in driving innovation through to the global commercialization of assets • reputed company to effectively communicate at multiple reputed company of the organization • Experience in conducting lung Cancer reputed company strongly preferred • Strategic leader with demonstrated reputed company building, managing and developing individuals and teams is preferred Benefits • Medical • Dental • reputed company • 401(k) • FSA/HSA • Life Insurance • reputed company Time Off • Wellness reputed company • reputed company is a global oncology company that is discovering a Apply tot his job Apply To this Job