Note: The job is a remote job and is open to candidates in USA. BeOne Medicines is a global oncology company focused on developing impactful medicines and expanding access to innovation through its integrated Global Development SuperHighway and external partnerships. The Senior Director Clinical Development, Solid Tumor, leads clinical development strategy for partnership program assets, oversees compliant and high-quality clinical study execution, interprets clinical data, supports regulatory submissions, and manages clinical development teams and stakeholders.
Responsibilities
- Accountable for clinical development strategy and development of clinical development plan that meet worldwide regulatory and commercial/access needs for the partnership program assets
- Within the partnership program, make recommendations in clinical development area and accountable for planning and ensuring the high-quality and compliant results submitted to regulatory agencies
- Partner with other core-team members in the partnership program and Execution Units for the successful implementation and execution of clinical studies
- Provide scientific expertise for selection of investigator and vendors
- Provide scientific and medical guidance/support throughout conduct of a clinical trial
- Review, query, and analyze clinical trial data
- Interpret, and present clinical trial data both internally and externally
- Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
- 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, as well as 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 etc
- Provide responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, investigators, and CROs etc
- Consult with Advisory Committee for relevant topics and incorporate the ideas into strategy and execution if appropriate
- Provide guidance/training to function team in Execution Unit, CRO staff and study site staff on the therapeutical area, molecule, and/or clinical protocol and may provide coach and mentorship to the team members working on the assets when there’s performance concern and for team development purpose
- Conduct regular review meetings with Execution Units with the partnership program core team to mentor, support, and ensure all studies are tracking to quality and timeline
- Report on study status, goals, operational KPIs, and enforce quality KPIs
- Champions a global mindset and approach across Global Development to foster collaboration and consistency across the organization
- Point of escalation for all assets’ related issues and report back to the partnership program core team for discussion and alignment
- Contribute to or perform therapeutic area/indication research and competitor analysis
- Participate company-wise standard discussion, finalization, and implementation
- Other duties as assigned
Skills
- MD, DO degree or equivalent in a related discipline required, with a minimum of 6+ years of clinical development experience including 5 or more years in oncology therapeutic area
- Skilled in Microsoft Office Suite
- Professional knowledge and skills in oncology therapeutics required
- Strategic leader with demonstrated success building, managing, and developing teams
- Working knowledge of applicable international compliance guidelines and regulations
- Fluent in written and verbal English
- Up to 20%. Ability to travel domestically and internationally
- 10+ years preferred
- Experience working in a global environment required; deep understanding of immuno-oncology strongly desired
Benefits
- Non-Commercial roles are eligible to participate in the annual bonus plan.
- All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards.
- All employees are eligible to voluntarily participate in the Employee Stock Purchase Plan.
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Company Overview
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