ZipRecruiter

Log In

1

Director Ivd Jobs (NOW HIRING)

AstraZeneca

Director, Diagnostics

Boston, MA · On-site

Technology and IVD SME: Serve as subject matter expert for IVD technologies and development pathways; guide assay selection, analytical performance, clinical utility, and commercialization readiness.

AstraZeneca

Director, Diagnostics

Boston, MA · On-site

Technology and IVD SME: Serve as subject matter expert for IVD technologies and development pathways; guide assay selection, analytical performance, clinical utility, and commercialization readiness.

AstraZeneca

Director, Diagnostics

Boston, MA · On-site

Technology and IVD SME: Serve as subject matter expert for IVD technologies and development pathways; guide assayselection, analytical performance, clinical utility, and commercialization readiness.

Predicine, Inc

Head of Manufacturing

Hayward, CA · On-site

Head of Manufacturing - In Vitro Diagnostics (IVD) / Molecular Diagnostics / NGS Full-Time | Onsite Overview We are seeking a seasoned Head of Manufacturing to lead end-to-end manufacturing ...

CorDx

Marketing Manager

Alpharetta, GA · On-site

As a Marketing Director at CorDx, you will be responsible for developing and implementing ... Strong understanding of the IVD market, products, and regulatory environment. * Exceptional ...

next page

Showing results 1-20

All JobsIvd JobsDirector Ivd Jobs

Director Ivd information

What are the key skills and qualifications needed to thrive as a Director, IVD (In Vitro Diagnostics), and why are they important?

To thrive as a Director, IVD, you need extensive knowledge of diagnostics, regulatory compliance, and leadership experience, often supported by an advanced degree in life sciences or related fields. Familiarity with quality management systems, FDA/CE regulations, and laboratory information management systems (LIMS) is typically required. Exceptional strategic thinking, communication, and team management abilities distinguish top performers in this role. These competencies ensure effective leadership, regulatory success, and innovation in a highly regulated and rapidly evolving sector.

What are some common challenges faced by a Director of IVD (In Vitro Diagnostics) when leading cross-functional teams?

A Director of IVD often encounters challenges in aligning the priorities of diverse teams such as R&D, regulatory affairs, manufacturing, and marketing. Balancing innovation with strict regulatory compliance requirements can be complex, especially when managing projects across global markets. Additionally, fostering effective communication between technical and non-technical stakeholders is crucial to ensure projects stay on track and meet business objectives. Strong leadership and project management skills are essential to navigate these challenges and drive successful product development.

What is the difference between Director Ivd vs Medical Laboratory Director?

AspectDirector IvdMedical Laboratory Director
CredentialsTypically requires CLS/MT certification, relevant degree, and managerial experienceRequires medical director certification, medical degree, and clinical laboratory experience
Work EnvironmentOversees in vitro diagnostic device development and manufacturingManages clinical laboratory operations and compliance
Industry UsageUsed mainly in biotech and diagnostics companiesCommon in hospital, clinical, and reference labs

The main difference is that a Director Ivd focuses on in vitro diagnostic products, including development and regulatory compliance, while a Medical Laboratory Director oversees clinical laboratory operations and patient testing. Both roles require relevant certifications and industry experience but serve different functions within the healthcare and diagnostics sectors.

What is a Director IVD?

A Director IVD (In Vitro Diagnostics) is a senior executive responsible for overseeing the development, regulatory compliance, and commercialization of diagnostic tests and devices that analyze samples outside the human body. This role involves managing teams, ensuring products meet both scientific and regulatory standards, and collaborating with cross-functional departments such as R&D, quality assurance, and marketing. Directors IVD play a crucial role in guiding product portfolios, driving innovation, and ensuring that diagnostic solutions are safe, effective, and meet market needs. Their work has a direct impact on patient care and disease management worldwide.
More about Director Ivd jobs
What cities are hiring for Director Ivd jobs? Cities with the most Director Ivd job openings:
What are the most commonly searched types of Ivd jobs? The most popular types of Ivd jobs are:
What states have the most Director Ivd jobs? States with the most job openings for Director Ivd jobs include:
What job categories do people searching Director Ivd jobs look for? The top searched job categories for Director Ivd jobs are:
Director Ivd jobs near you
Director, Diagnostics

Director, Diagnostics

AstraZeneca

Boston, MA • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 15 days ago

AstraZeneca rating

8.6

Company rating: 8.6 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

16th of 71 rated pharmaceutical

Job description

Role Summary
  • Lead the Diagnostics Center of Excellence (DxCoE) strategy and execution across the rare disease portfolio, shaping end-to-end diagnostic approaches from late discovery/early clinical through development, registration, launch, and lifecycle management.

  • Own clinical trial diagnostic strategy, including patient selection, biomarker-driven enrichment, and Companion Diagnostic (CDx) development, ensuring speed of enrollment, data quality, and regulatory readiness.

  • Build capabilities, processes, and partnerships that shorten the diagnostic odyssey and enable precision medicine at scale.

Key Responsibilities
  • Strategy and Portfolio Leadership: Define disease-specific diagnostic strategies grounded in deep understanding of patient diagnostic journeys, clinical practice, and healthcare systems; prioritize portfolio impact and resource allocation.

  • Clinical Trial Diagnostics and CDx: Lead trial-level diagnostic strategies (assays, algorithms, inclusion criteria), CDx definition and development, and readiness for co-approval of drug and CDx, drive timelines to meet enrollment and submission milestones.

  • Regulatory Excellence: Partner with internal device/diagnostic regulatory and external partners to deliver global submissions (FDA IDE, PMA; EU IVDR CPS and performance dossiers; other regional requirements) and sustain compliance under design control.

  • Translational Integration: Collaborate with Translational Science & Medicine to translate disease/target/MOA hypotheses into fit-for-purpose biomarkers and clinical endpoints; ensure analytical and clinical validation plans are robust.

  • Technology and IVD SME: Serve as subject matter expert for IVD technologies and development pathways; guide assay selection, analytical performance, clinical utility, and commercialization readiness.

  • External Partnerships: Identify, select, and manage diagnostic partners; negotiate scope, budgets, and deliverables; oversee execution with clear success metrics and risk mitigation.

  • Operating Model and Governance: Establish processes, standards, and dashboards for diagnostic initiatives; ensure timely communication and alignment with program teams, governance bodies, and senior leadership.

  • Budget and Resource Management: Secure budgets, optimize vendor and internal resourcing, and maintain transparency on timelines, risks, and outcomes.

  • Horizon Scanning: Maintain up-to-date view of emerging tests, platforms, and guideline updates; evolve strategies to reflect scientific, clinical, and regulatory changes.

Qualifications
  • Advanced degree (PhD or equivalent) in a relevant scientific field; 10+ years in precision medicine/diagnostics within pharma/biotech, spanning discovery to launch.

  • Proven track record leading diagnostic strategy and execution for clinical programs, including CDx development and PMA approval in partnership with diagnostic companies.

  • Hands-on experience with global regulatory pathways (FDA IDE/PMA; EU IVDR CPS/performance requirements), design control, and quality system expectations.

  • Deep expertise in biomarker validation (analytical/clinical) and IVD development; familiarity across modalities and methodologies (genomics, proteomics, metabolomics; immunoassays, biochemical assays, NGS, etc.).

  • Strong portfolio thinking with the ability to translate disease biology and patient journey insights into actionable diagnostic strategies and business cases.

  • Exceptional cross-functional leadership, communication, and stakeholder management across discovery, clinical development, regulatory, commercial, and medical affairs.

  • Demonstrated success building new capabilities, processes, and partnerships; comfortable leading in ambiguity and delivering against aggressive timelines.

  • Experience managing external vendors/alliances and complex budgets; disciplined in risk management and governance.

  • Self-starter with a delivery mindset; able to both set direction and roll up sleeves as needed.

  • Ability to work in an office-based environment and perform essential functions with or without accommodation.

The annual base pay for this position ranges from $ 180,740.80 - $271,111.20. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Date Posted
02-Jun-2026
Closing Date
15-Jun-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

What AstraZeneca employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply