Director CDx Development

BeOne Medicines; United States; In loco; USD 176.600 - 236.600; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental, Vision

401(k)

Equity awards

Employee Stock Purchase Plan

Descrizione del lavoro

BeOne Medicines is seeking a Companion Diagnostics (CDx) Lead to define and execute end-to-end diagnostic strategies aligned with clinical development programs and timelines. You will partner with research, regulatory, and commercial teams, as well as external IVD collaborators, to drive CDx development, regulatory approval, and launch for precision medicine.

You will lead cross-functional CDx programs, define Target Product Profiles, and oversee regulatory documentation while ensuring on-time

Competenze

• PhD with 5+ years of industry experience in clinical biomarker testing and companion diagnostics development.
• Strong scientific and regulatory knowledge for IVD and CDx products.
• Hands-on experience with diagnostic platforms (NGS, IHC, FISH).
• Ability to lead cross-functional programs and influence stakeholders.

Mansioni

• Lead end-to-end CDx strategies across clinical development programs.
• Collaborate with Translational Discovery, Research, Regulatory, and Commercial teams.
• Define Target Product Profiles and identify diagnostic platforms and partners.
• Support regulatory submissions and interactions with health authorities.
• Oversee CDx development activities to ensure on-time delivery.
• Communicate program progress, risks, and mitigation plans to stakeholders.
• Monitor industry trends and evolving regulatory requirements for IVDs.

Descrizione del lavoro

BeOne 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 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

• Not required

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.

Equal Opportunity Employer

We are proud to be an equal opportunity employer. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].