BeiGene 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.

General Description: The Diagnostics Lead (Director) in the Clinical Biomarker Sciences and Companion Diagnostics Development department is responsible for developing and executing end-to-end diagnostic strategies in alignment with clinical development timelines. The Diagnostics Lead will conceive and develop companion diagnostics (CDx) strategies, define Diagnostic Target Product Profiles (DxTPP), identify suitable assays and CDx partners, and obtain endorsements from governance bodies. Additionally, the role requires overseeing CDx development, ensuring timely delivery of CDx kits for pharmaceutical registration and launch, and staying updated with industry trends and regulatory requirements.

Essential Functions of the job:

Develop end-to-end diagnostic strategy in collaboration with key stakeholders and ensure alignment with clinical development strategies and timelines.

Interact early with Translational Discovery and Research to understand the predictive hypotheses to be tested for specific programs. Collaborate with internal research capabilities or external vendors to develop a predictive assay if not already available.

Conceive and develop CDx strategies for clinical development programs and obtain endorsement from various governance bodies (e.g., DCT, DRC, BPRC etc.).

Work with a cross-functional team to define Diagnostic Target Product Profile (DxTPP) and identify suitable assays and CDx partners based on DxTPP.

Work with Regulatory Affairs to ensure that regulatory documents (e.g., IDEs, PMAs, etc.) are delivered and communicate with health authorities when required.

Oversee the CDx development and ensure timely delivery of a CDx kit for pharmaceutical registration and launch.

Communicate updates to, and seek feedback from, cross-functional stakeholders surrounding the progress of the CDx program.

Stay up to date with industry trends, technology advancements, and regulatory requirements for IVD and CDx.

Drive diagnostic product innovation and improvement through both in-house R&D efforts and in collaboration with IVD partners.

Supervisory Responsibilities:  

Participate in other training, supervisory and management activities as required by the company.

Computer Skills:   Microsoft Office, data analysis skills

Education Required:

Ph.D./MD preferred with 5+ years of related experience.

Other Qualifications:

5+ years of industry experience in clinical biomarker testing and CDx development.

Deep understanding of scientific concepts, clinical development processes, clinical testing guidelines, and the regulatory requirements for IVD products and CDx.

Ability to identify key information and make data driven decisions.

Ability to use critical and strategical thinking to handle complex or ambiguous situations.

Ability to articulate facts, ideas, and strategies in all communication formats.

Ability to set and manage stakeholder expectations, ability to influence without authority.

Ability to work effectively in a matrixed environment, ability to manage cross-functional teams.

Travel:  up to 10%

BeiGene Global Competencies

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

Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

Salary Range: $175,800.00 - $235,800.00 annually

BeiGene 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 BeiGene 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.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.