The Executive Companion Diagnostic (CDx) Lead, GMA, will support BeOne Clinical and Medical assets by successful execution of Global Medical Affairs Companion Diagnostic program, working closely with commercial CDx program as well as inform Clinical Development in informing their CDx strategy. The candidate will report to the Vice President, Global Medical Affairs, Solid Tumors. As a leader in the organization, the incumbent will be involved in developing and executing a CDx Global Medical Strategy as well as working closely with the commercial CDx lead and Clinical Development CDx lead to inform future CDx strategy. The CDx program strategy and help assure that activities are executed within expected scope, budget and timelines. The incumbent will work closely with colleagues in global medical affairs, clinical development, program leadership, biometrics, clinical operations, and translational research.
Essential Functions of the Job: - Develop a Global CDx medical Affairs Strategy
- Support and implement cross-functional plan for successful CDx launch programs
- Generate clinical and real-world evidence (eg IITs, testing utilization studies, diagnostic accuracy studies, clinical utility studies)
- Work closely with GMA disease lead to integrate the CDx strategy with the overall Medical Strategy.
- Lead and oversee any data generation efforts utilizing LDTs of follow-on CDx testing, aligning with overall global CDx strategy.
- Provide global (inclusive of regional) insights into pipeline programs requiring CDx
- Engage key opinion leaders (KOLs) in pathology and oncology to ensure successful launch of CDx
- Cross-functional support of market launch readiness, aligning with commercial CDx activities.
- Engage in feedback and advice from KOLs (oncologists and pathologists) on minimizing barriers and optimizing utilization of CDx, as well as validate future data generation needs.
- Internal training of medical teams and field teams, with right-size training on CDx.
- Support scientific publications
- Provide medical review of diagnostic materials (PRC, MRC etc)
- When appropriate be the GMA representative at Alliance partnerships
- Develop, track, execute and report on goals and objectives.
- Support budget planning and management.
- Be accountable for compliant business practices.
Qualifications and Experience: - Advanced degree (MD, PharmD, PhD, or MD equivalent) with subspecialty training in oncology.
- Extensive experience in pharma/biotech in solid tumors is required.
- 8 plus years of experience within other biotech/pharmaceutical company.
- Clinical solid tumor oncology experience and former CDx medical experience is mandatory for this role.
- Previous experience in Medical Affairs in a CDx role is strongly preferred.
- Expert understanding of incorporation of biomarker and development of CDx in a global clinical study.
- Deep understanding of LDTs and extent of data generation to support launch of CDx and utilization of companion-drug.
- High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
- Knowledge of GCP and ICH Guidelines.
- Flexibility to work with colleagues in a global setting.
- Able to engage in work-related travel approximately 25%.
- Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred.
- Experience with the development and support of related SOPs and policies is expected.
- Knowledge of industry standard Clinical Development IT solutions expected.
Other Qualifications: - Executive presence and ability to influence and lead.
- Exceptional cross-functional collaboration within GMA and with other departments.
- Accountable and results-driven.
- Impactful written and verbal scientific communication.
- Problem solving and risk-mitigation skills.
- Confident, positive attitude
- Flexibility and embracing change.
Travel: 25%
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: $296,600.00 - $376,600.00 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.
