Senior Director Clinical Development, Solid Tumor

About the role

BeOne is opening its Global Development SuperHighway—a unique, integrated, end-to-end internal development capability—to the world’s most promising external science. Through these SuperHighway partnerships, highly promising assets from leading biotech partners can access our development engine, creating a win-win ecosystem with the ultimate goal of helping more patients around the world. This is not a fee-for-service model; it is a bold new way to grow the company and expand what’s possible in oncology.

As Clinical Development Lead, you will be accountable for developing clinical program strategy and ensuring that activities are executed within expected scope, budget, and timelines for our partnership programs under the Development SuperHighway. You will provide clinical development leadership and collaborate with other core-team members to ensure successful delivery by the execution functions. This role helps deliver the partnership studies that run on our Clinical SuperHighway, supporting seamless onboarding and high-quality execution of external partner projects.

Responsibilities

• Accountable for clinical development strategy and development of clinical development plans that meet worldwide regulatory and commercial/access needs for the partnership program assets.
• Make recommendations in the clinical development area and ensure high-quality, compliant results are submitted to regulatory agencies.
• Partner with other core-team members and Execution Units for the successful implementation and execution of clinical studies.
• Provide scientific expertise for the selection of investigators and vendors.
• Provide scientific and medical guidance/support throughout the conduct of a clinical trial.
• Review, query, and analyze clinical trial data; interpret and present 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 protocols, amendments, informed consent documents, Investigator Brochures, Clinical Study Reports, abstracts, posters, manuscripts, and clinical sections of regulatory submissions (INDs, NDAs, annual reports, etc.).
• Provide responses to queries relating to study design, analysis, and interpretation from clinical monitors, regulatory agencies, investigators, and CROs.
• Consult with Advisory Committees on relevant topics and incorporate ideas into strategy and execution.
• Provide guidance/training to Execution Unit teams, CRO staff, and study site staff on therapeutic areas, molecules, and/or clinical protocols; mentor team members as needed.
• Conduct regular review meetings with Execution Units and the partnership program core team to mentor, support, and ensure studies track to quality and timeline.
• Report on study status, goals, operational KPIs, and enforce quality KPIs.
• Serve as the point of escalation for all asset-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 in company-wide standard discussions, finalization, and implementation.
• Other duties as assigned.

Requirements

• 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 the oncology therapeutic area.
• 10+ years of experience preferred.
• Professional knowledge and skills in oncology therapeutics.
• Strategic leader with demonstrated success building, managing, and developing teams.
• Working knowledge of applicable international compliance guidelines and regulations.
• Experience working in a global environment; deep understanding of immuno-oncology strongly desired.
• Fluent in written and verbal English.

Skills

• Skilled in Microsoft Office Suite.
• Fosters teamwork and collaboration.
• Provides and solicits honest, actionable feedback.
• Self-awareness and acts inclusively.
• Demonstrates initiative and an entrepreneurial mindset.
• Continuous learning and embraces change.
• Results-oriented with strong analytical thinking and data analysis skills.
• Financial excellence and communicates with clarity.

Benefits

• Comprehensive benefits package including Medical, Dental, Vision, and 401(k).
• FSA/HSA, Life Insurance, and Paid Time Off.
• Wellness programs.
• Eligibility to participate in the annual bonus plan (non-commercial roles) or incentive compensation plan (commercial roles).
• Opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and the Employee Stock Purchase Plan.

Pay

Salary range: $299,800.00 - $369,800.00 annually. Actual compensation is determined by job-related skills, depth of experience, certifications, relevant education or training, and specific work location.

Schedule

• Up to 20% travel, domestically and internationally.