BeOne Medicines · 1 day ago
Executive Director, Clinical Development
United States
Full-time
Remote
Director/Executive
$330K/yr - $410K/yr
8+ years expBeOne Medicines is a rapidly growing company focused on fighting cancer through innovative clinical development. The Executive Director, Clinical Development will lead high-impact clinical projects, ensuring the successful execution of clinical development programs in collaboration with various teams and external partners.
Pharmaceuticals
Responsibilities
Key contributor in Clinical Development strategy, planning, and leading presentations to various internal governance committees
Provide leadership and clinical oversight for all assigned studies and programs, including at least one ground-breaking early phase project with clinical applications across tumor types, and one mature project with substantial ongoing registrational activities
Seamless transition of drug candidates from research to early clinical development
Effective integration of in-licensed drug candidates into clinical development portfolio
Effective development of assets according to stringent criteria
Effective transition of assets from early to late clinical development
Significant contribution and oversight of clinical development activities in support of worldwide Health Authority interactions
Engagement with KOL’s and Collaborators
Training of clinical team and other functional teams, as appropriate
Assessment of Investigator Initiated and Collaborator Research program
Facilitate generation of, author, update, and/or review key documents
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
Risk/Benefit 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 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
Understand competitive clinical development landscape, contribute to or perform therapeutic area/indication competitor research and adjust strategy accordingly
Identify strategic and incremental organizational resource needs re: People, Process, and Technology
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
Advanced degree in a relevant scientific or clinical discipline (e.g. MD, PhD, or PharmD) with a minimum of 8+ years of experience and success within biotech/pharmaceutical industry and/or equivalent experience in academia
Professional knowledge and skills working in oncology therapeutics across solid tumor types is required
Proficiency in translational medicine is required
Strategic leader with demonstrated success building, managing, and developing individuals and teams
Working knowledge of applicable International Compliance guidelines and regulations is expected
Experience working in a global environment is required
Experience with the development and support of related SOP's and policies is expected
Experience with partnerships and strategic alliances is expected
Preferred
Extensive history of participation in filing activities leading to global approvals 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