Director Clinical Development, Medical Monitor

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:

Cross-Functional Team Membership

• Participates in and/or leads the relevant Therapeutic Team (TT) and/or represents CD in Study Team relevant to assigned molecule(s)/indication(s) and helps ensure cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution.

• May also, as appropriate, support relevant Study Team in training new team members.

• As appropriate, participates in ongoing enhancements/development of core and study team processes, structures, systems, tools and other resources.

Clinical Development Planning

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s).

• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects.

• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.

• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups.

• May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance.

• Responsible for creating and implementing the CD plan for assigned molecule(s)/indication(s) and/or other programs together with CST and other relevant teams.

• Communicates with HAs, as and when needed, or otherwise appropriate. Ethically, effectively and professionally represents the interests of BeOne and patients.

Clinical Development Plan Implementation

• Provides clinical oversight across all relevant studies and programs; leads and/or otherwise participates in ongoing TT and relevant study team meetings, other interactions and communications.

• Designs and develops clinical studies; collaborates with others in the development of the product safety profile and clinical sections of investigator brochures, presentations and other materials.

• May participate in the identification and selection of appropriate external investigators and sites.

• Ensures investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study. Acts as a medical monitor for assigned studies.

• Conducts ongoing reviews of medical/safety data.

• Collaborates with relevant teams and other groups to measure and monitor study progress against objectives, proactively communicate any issues, challenges and potential strategies to resolve such.

• Collaborates with other groups to ensure timely and appropriate completion of interim and final study reporting; accountable to ensure correct medical/scientific data interpretation for interim and final study reporting.

• Plays a lead role in the development and implementation of communications strategies to support existing and concluded studies, including KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials.

• Works with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes.

• Develops and delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities.

• Drives ongoing data generation to address unmet medical needs and recommend new or extended CD studies or other programs to his/her manager and others in the relevant therapeutic area of assignment.

• Completes and/or leads other special projects, as and when assigned, or otherwise requested.

• Consistently complies with, and ensures the same among relevant CST members, all governing laws, regulations, BeOne Standard Operating Procedures (SOPs) and other guidelines.

Education Required:

• MD, DO degree or equivalent in a related discipline required, with a minimum of 5+ years of clinical development experience including experience in oncology therapeutic area.

• 10+ years preferred

Computer Skills:

• Skilled in Microsoft Office Suite

Other Qualifications:

• M.D. with relevant medical experience in Oncology area required. Academic/teaching background is a plus.

• Can effectively contribute to development of disease strategies.

• 5+ years pharma/biotech industry experience OR is a recognized expert in the field.

• 5 years experience with clinical trials, Oncology trials preferred.

• Strong orientation to teamwork.

• Clinical leadership: is regarded as an expert in his/her field, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results.

• Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such.

• Outstanding communication skills, both written and verbal.

Travel:

• Up to 20%. Ability to travel domestically and internationally.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.