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 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.

Education Required:

• 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.
• 10+ years preferred

Supervisory Responsibilities:

• Manages direct reports (e.g., Medical Directors / Clinical Scientists) supporting the assigned partnership programs.

Computer Skills:

• Skilled in Microsoft Office Suite

Other Qualifications:

• 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.
• Experience working in a global environment required; deep understanding of immuno-oncology strongly desired.
• Fluent in written and verbal English;

Travel:

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

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $299,800.00 - $369,800.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.