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. 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. 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 accommodationsus@beonemed.com.
Director CDx Development
Location
United States
Posted
2 days ago
Salary
$176.6K - $236.6K / year
Seniority
Lead
No structured requirement data.
Job Description
Director CDx Development
BeiGene
Role 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. - 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. Qualifications - 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. Requirements - Travel: Not required Benefits - Salary Range: $176,600.00 - $236,600.00 annually - Participation in the annual bonus plan for Non-Commercial roles and incentive compensation plan for Commercial roles. - Opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and Employee Stock Purchase Plan. - Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. Company Description 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. 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 accommodationsus@beonemed.com.
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Role Description Your work will change lives. Including your own. The Impact You’ll Make: Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential targets, using technology and standardization to build connected data, and superlinearly scaling our efforts to accelerate the delivery of high-potential drug candidates to the clinic. We are seeking a Director of Regulatory Affairs who will play a critical role in supporting global regulatory strategy, overseeing processes, and identifying and managing regulatory risks for the assigned programs. - Build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization to ensure management of regulatory strategy and activities in all applicable regulatory jurisdictions (e.g. EU, US, UK) for the global development of products through all stages of development and post-approval. - Participate in global product team meetings; provide regulatory support and guidance and manage day-to-day regulatory activities. - Manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion while practicing sound judgment as it relates to risk assessment. - Create and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs. - Create, collaborate and comply with disclosure and transparency policies for applicable jurisdictions. - Collaborate with strategic operations and other functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight for futuristic planning and considerations for the program. - Serve, as needed, as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders. - Review and interpret regulatory guidelines and create a communication plan to distribute relevant impact assessment. - Creatively think outside the box on how to influence and shape the future of regulatory sciences as it relates to use and validation of unprecedented use of technology to develop drugs effectively for faster paths to patients. - Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. - Represent regulatory function and demonstrate respectful behavior, leadership, ethics and transparency. Qualifications - A minimum of 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs. - Experience with major Health Authorities (US FDA, Health Canada, UK MHRA and EMA) is mandatory. - Oncology, rare disease, and I&I experience is good to have. - Minimum of 8 years experience with regulatory submissions (e.g. INDs, NDAs, post marketing measures, PIPs, ODD, BTD, EU PRIME activities) are mandatory. - Strong understanding of regulatory strategy and implementation of operational activities. - Outstanding management, interpersonal, communication, negotiation, and problem-solving skills. - Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global teams. Requirements - This role is remote-friendly, with most work conducted from home. - There may be occasional opportunities or expectations for travel to our Salt Lake City headquarters or other office locations. Benefits - Estimated annual base salary range for New York City, Boston, & San Francisco Bay Area(s): $228,250–$280,720. - Estimated annual base salary range for Salt Lake City & all other U.S. locations: $207,500–$255,200. - This role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package. Company Description Recursion (NASDAQ: RXRX) is a clinical-stage TechBio company decoding biology to radically improve lives. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need. Enabling its mission is the Recursion OS, an AI-native, end-to-end drug discovery and development platform integrating biology, chemistry, and clinical development into a unified intelligence system. Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire, where its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York, Montréal, and London, three global hubs for talent and leadership at the intersection of AI and scientific innovation.
• Execute/direct/oversee data analyses, initiate interpretations and conclusions, and oversee verbal and graphic presentations, using methods that are professionally sound and efficient relative to project objectives and conform to standards. • Perform quality assurance on project deliverables. • Assist in determining client needs by effectively leading client interviews and utilizing various tools and analytical methods. • Summarize analytical findings in a coherent manner and draws insight from observations, interviews and data analyses. • Develop accurate conclusions from findings. • Drafts recommendations and potential solutions for team leadership review. • Develops final recommendations and solutions for client review. • Effectively execute on project plans in accordance with engagement statements of work and to client satisfaction. • Guide team in developing presentations and deliverables for client audiences that communicate strategy and outcomes. • Generate billings revenue by leading the engagements in the project delivery. • Guide and lead project management related activities for assigned projects. • Manage the budget and expenses for their assigned projects and manage project profitability. • Manage staff assigned to their projects including providing mentoring and education for staff. • Participate in risk and issue identification and mitigation along with the project leadership team. • Identify opportunities for add on sales and communicate those to engagement leadership and participate in activities to aid in closing those opportunities. • Advise on the clinical operations of the outpatient infusion center, including infusion protocols, patient throughput, and access optimization for those in need. • Ensure continuous implementation of best practices and new infusion protocols in line with advances in medical care. • Support and advise on electronic health system updates, order sets, site of care policies, revenue cycle prior authorization automation and improvements in workflow and patient access. • Fosters a collaborative, multidisciplinary environment between infusion services, home care, and other stakeholders.
• Develop and execute the long-term strategy for the Company's retirement and financial wellness programs. • Evaluate and recommend plan design enhancements that support employee attraction, retention, engagement, and retirement readiness. • Benchmark retirement programs against market practices and emerging industry trends. • Lead analysis of retirement program effectiveness, participation rates, savings outcomes, income replacement, and utilization metrics. • Develop business cases and recommendations for executive leadership and governance committees. • Lead and develop retirement benefits team members, as applicable. • Collaborate with Compensation, Payroll, Finance, Legal, Internal Audit, and Communications teams. • Present recommendations and updates to senior leadership and governance committees. • Serve as a key member and advisor to the Administrative Benefits Plan Committee and other fiduciary governance bodies. • Partner with investment consultants and advisors to monitor investment performance and plan fund lineups. • Oversee administration of the company’s 401(k) plans and ensure accurate and timely plan operations. • Manage plan amendments, restatements, participant communications, and operational changes. • Ensure compliance with ERISA, Internal Revenue Code, SECURE Act and related legislation, DOL regulations, IRS requirements. • Lead relationships with retirement recordkeepers, trustees, custodians, investment consultants, auditors, actuaries, and other service providers. • Manage retirement program budgets and administrative expenses. Analyze plan costs, fee structures, investment expenses, and utilization trends. • Develop retirement education and financial wellness strategies. Partner with vendors to deliver effective participant communication campaigns.
• Supports the growth of our in-plan Advisor Managed Account program across all retirement Institutional markets in partnership with business segment leads. • Manages the relationship with Registered Investment Advisors (RIAs) and drives the strategy, implementation and ongoing management of the Advisor Managed Account program by deepening relationships with RIAs and driving plan sponsor and participant adoption and satisfaction through exceptional delivery of advice and guidance. • Cultivate relationships with RIAs and help grow their in-plan advisory business with Voya. • Identify business opportunities to leverage Voya's Advisor Managed Account capabilities, including Private Asset investment, to drive value for the RIAs and their clients on Voya's platform. • Deepen relationships with RIAs through regular meetings, reporting, and delivering on commitments. • Provide feedback and drive program enhancements that make it easy to do business with Voya. • Solicit feedback from key stakeholders including sales, relationship management, product management, marketing, qualified plan business partners, independent broker-dealer reps, investment advisor representatives, vendors and the internal departments that support the investment advisory platforms. • Be a student of the retirement advisory space by staying abreast of all advisory industry product and regulatory changes. • Work with compliance, product management, risk management, distribution and operations management to ensure compliance with policies and procedures, and timely issue resolution of any incident tickets. • Anticipate future changes including those that may affect customers' expectations of investment advisory products and services, technological development, changing customer segments, and evolving regulatory requirements.




