Senior Director Clinical Development, Solid Tumor

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

At BeOne, our Global Development SuperHighway — our integrated, end-to-end, wholly internal development capability — is a cornerstone of our R&D vision. It brings together a unique set of internal cross-functional capabilities from across the globe needed for efficient delivery of clinical trials to develop impactful medicines to accelerate access to innovation for patients around the world.

We are now opening this same delivery engine to the world’s most promising external science. Through SuperHighway partnerships, highly promising assets from leading biotech partners can access our development capabilities creating a true 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. This is a rare opportunity to help build something genuinely new — joining a high-caliber, agile team at the leading edge of clinical development innovation. If you are energized by building, by challenging the status quo, and by making a real impact on patients’ lives, this is where you belong.

The Clinical Development Lead is accountable for developing clinical program strategy and assuring that activities are executed within expected scope, budget, and timelines for our partnership programs under the Development SuperHighway. The Lead provides clinical development leadership and co-works 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 in close partnership with the execution functions.
Essential Functions of the Job:

- 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