BeOne Medicines · 9 hours ago
Director, Clinical Development-Biotech Unit
United States
Full-time
Remote
Lead/Staff, Director/Executive
$250K/yr - $310K/yr
5+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer, seeking experienced professionals for their Clinical Development team. The Director will contribute to clinical development strategy and ensure successful execution of clinical development programs, leveraging expertise in medical monitoring and collaboration across various teams.
Pharmaceuticals
Responsibilities
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 BeOne 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 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-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
Qualification
Required
5 plus years of experience and success within other biotech/pharmaceutical companies
MD or DO or international equivalent degree required
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 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
Able to engage in work-related travel approximately 25%
Experience with the development and support of related SOPs and policies is expected
Knowledge of industry standard Clinical Development IT solutions expected
Have the ambition and passion to drive value and impact with a 'can-do' attitude, willing to take calculated risk
Adopt an open and creative mindset to pilot new concepts and overcome challenges
High learning agility
Support strategic clinical development within Biotech Unit; integrate business case, mitigate risks and manage resources
Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events
In-depth medical knowledge to drive operational excellence
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 matrix; able to work effectively in diverse cultures, showing aptitude in modifying style
Business acumen - understand unmet market needs; provide clear path to win; demonstrated track record in driving innovation through to the global commercialization of assets
Able to effectively communicate at multiple levels of the organization
Preferred
Experience in conducting lung Cancer clinical trials strongly preferred
Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase