General Description: The Companion Diagnostics (CDx) Lead will be responsible for defining and executing end-to-end diagnostic strategies that are fully aligned with clinical development programs and timelines. This role partners closely with research, clinical, regulatory, and commercial teams, as well as external IVD collaborators, to ensure the successful development, regulatory approval, and launch of companion diagnostics that enable precision medicine.
Essential Functions of the Job: - Lead the development and execution of integrated CDx strategies across clinical development programs, ensuring alignment with overall drug development objectives and timelines.
- Engage early with Translational Discovery and Research teams to understand predictive hypotheses and biomarker strategies for pipeline programs.
- Partner with internal research teams and external vendors to develop predictive assays when suitable assays are not already available.
- Define and advance CDx strategies through internal governance bodies, securing timely alignment and endorsement.
- Collaborate cross-functionally to define Diagnostic Target Product Profiles and identify optimal diagnostic platforms and CDx partners.
- Work closely with Regulatory Affairs to support the preparation and submission of regulatory documentation (e.g., IDEs, PMAs) and to interact with global health authorities as needed.
- Oversee CDx development activities to ensure on-time delivery of diagnostic kits to support pharmaceutical registration and commercial launch.
- Provide clear, proactive communication to cross-functional stakeholders on CDx program progress, risks, and mitigation strategies.
- Monitor and interpret emerging industry trends, technology advancements, and evolving regulatory requirements related to IVDs and companion diagnostics.
Supervisory Responsibilities: - Contribute to broader training, leadership, and management activities as required.
Requirements: - PhD with a minimum of 5+ years of industry experience in clinical biomarker testing and companion diagnostics development, with a demonstrated record of successful drug and/or IVD approvals.
- Strong scientific and technical expertise in clinical development, biomarker strategies, and regulatory requirements for IVD and CDx products.
- Hands-on knowledge of diagnostic platforms such as NGS, IHC, FISH, and related technologies.
- Proven ability to lead complex, cross-functional programs to completion on time and within budget.
- Strong analytical and strategic thinking skills, with the ability to make data-driven decisions in ambiguous or complex situations and to think at a portfolio level.
- Demonstrated ability to influence and align stakeholders across development and commercial organizations without direct authority.
- Excellent communication skills, with the ability to convey complex scientific and strategic concepts clearly to both technical and non-technical audiences.
- Experience working effectively in a matrixed environment and leading cross-functional teams.
Travel: 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: $176,600.00 - $236,600.00 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.
