Program Director, Companion Diagnostics

at Quest Diagnostics
Location Marlborough, MA
Date Posted January 7, 2022
Category Default
Job Type Full-time

Description

Program Director, Companion Diagnostics –

Test Development Services

Recognized by FORTUNE magazine as one of the “World’s Most Admired Companies,” Quest Diagnostics (www.QuestDiagnostics.com) is the world's leading provider of diagnostic testing, information and services that doctors and patients need to make better healthcare decisions. We are pioneers in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care.

With corporate headquarters in Secaucus, NJ, Quest Diagnostics is a Fortune 500 company traded on the New York Stock Exchange (NYSE: DGX) and included in the Dow Jones Sustainability World Index, with 2020 revenues of $9.44 billion. 

Position Description

The Program Director is responsible for creating and leading Project IVD design process to deliver medical devices to support the external and internal diagnostic customers specifications.  The Program Director will be responsible for ensuring the design development of the IVDs meet regulatory requirements for submissions and  commercialization.  The Program Director will work closely with designated teams to direct, coach, and manage the activities associated with the development of medical devices to ensure the design development process is meeting the applicable regulatory requirements for intended markets. 

Responsibilities

Operations/Production:

  • Lead, collaborate, coach and work with R&D teams and Project Managers to support the development and optimization of IVD products and programs which include systems, assays, and instruments.
  • Drive new in vitro diagnostic product introduction to completion by advising teams and working with Regulatory Affairs, R&D scientists, IVD resources through the validation and regulatory submission phases of product development and design control.
  • Launch assays to comply with the FDA QSRs, ISO-13485, and IVDR Regulation standards.
  • Have a thorough understanding of CLSI guidelines in experiment design, PMA /FDA submissions, engagement with CDRH including lab customer testing needs.
  • Review and approve design validation protocol, data and documentation and support regulatory (FDA and Ex-US) for submissions.
  • Work with consultants, as needed, for successful strategic planning for IVD launch.
  • Identify gaps in IVD test launch program and create risk mitigation in collaboration with Pharma Partner.
  • Serve as alliance contact point with reagent and instrument manufacturers.
  • Serves as the R&D/CDx project lead for the Pharma customers.
  • Build strong internal relationships and collaborations with R&D, Medical Directors, Project Managers, Commercial, Regulatory, Finance and other key functions and teams. 
  • Evaluate and improve as needed SOPs for design control process which include templates for studies, reports, risk control process, FMEA, and verification and validation plans
  • Provide training to R&D teams.
  • Member of Management Review team
  • Traveling of is limited but is required occasionally when needed or as required as a people leader at Quest Diagnostics.

 

Qualifications

•         Requires a Bachelors Degree or MS in molecular diagnostics, molecular biology, engineering, or related field;  Advanced degree, PhD or MBA is a plus  

•         5+ years of experience in the IVD/diagnostics, medical devices, or environment under Design Control for the development of medical devices.

•         Solid understanding of Class III product development process and global regulatory requirements (FDA, EMA, ISO, cFDA, etc.)

•         Project Management skills: must be able to demonstrate the ability to plan and implement a project so that it proposes minimum impact to daily business requirements.

•         PC skills (spreadsheets, word documents)

•         Understand the requirements of a QSRs Quality System. ISO-13485 and GMP environment.

Competencies

•         Action oriented, Self-Starter, Drives for results.

•         Can work optimally and collaborate with cross-functional teams.

•         Priority Setting, Organizing and Planning skills.

•         Creativity, Problem Solving and Decision Quality

•         Directing and Coaching Others, Managing and Measuring Work

•         Managerial courage, standing alone.

•         Integrity and Trust

•         Communications (verbal and written)

•         Command Skills, Customer Focus

 

About Quest Diagnostics

Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. 

The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics also provides services to employers, life insurance companies, other commercial labs, clinics, health plans, government agencies, and organizations involved in clinical trials research.

Awards/Recognitions

•         FORTUNE magazine's "World's Most Admired Companies" list for 7 consecutive years; one of only five companies to attain Most Admired status in the "Health Care, Pharmacy and Other Services" industry category. 

•         Fortune magazine’s Fortune 500 list

•         Forbes Global 2000

•         Forbes' America's Best Employers List for third consecutive year

•         Forbes 2020 America’s Best Employers for Women for second consecutive year

•         S&P 500

•         Barron’s 500

•         Member of the Dow Jones Sustainability World Index

•         Included in the FTSE4Good, Calvert, and Ocean Tomo sustainability indices

•         Listed in the most recent Newsweek Green Rankings

•         Consistently named one of the best places to work in U.S. business journal rankings

•         Named a DiversityInc Noteworthy Company for third consecutive year

•         Listed on the Disability Equality Index (DEI), a joint initiative of the American Association of People with Disabilities (AAPD) and the US Business Leadership Network (USBLN), recognizing companies for prioritizing the inclusion of people with disabilities

•         Named Top 23 ‘Best Places to Work for LGBTQ Equality’ in New Jersey

•         Named a Best Place to Work for LGBTQ Equality by scoring a perfect 100 on the Human Rights Campaign Foundation’s 2021 Corporate Equality Index (CEI) for the fifth consecutive year.

•         Achieved Cancer Gold Standard accreditation from the CEO Roundtable on Cancer, recognizing our actions to reduce the cancer risk of employees and their families

•         Received C. Everett Koop National Health Award for Efforts to Promote Employee Health in 2020

Diagnostic Testing Services

Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. Their services range from routine blood tests — such as total cholesterol, Pap testing and white blood cell count — to complex, gene-based and molecular testing. They perform medical tests that aid in the diagnosis or detection of diseases, measure the progress or recovery from a disease or confirm that an individual is free from disease. In addition, they have specialized expertise in cancer, cardiovascular diseases, infectious diseases, and neurology.

About COVID-19 testing at Quest Diagnostics

Quest Diagnostics is at the forefront of the response to the COVID-19 pandemic, working to broaden access to laboratory insights to help us all lead healthier lives. We provide both molecular diagnostic and antibody serology tests to aid in the diagnosis of COVID-19 and immune response. Our COVID-19 test services are based on tests that have received FDA emergency use authorization and which also meet our high standards for quality. We are providing these test services under the Public Readiness and Emergency Preparedness Act.

We provide data on COVID-19 testing to various federal and state public health authorities, including the Centers for Disease Control and Prevention, and participate in studies with government and private institutions, aiding COVID-19 public health response and research. Through our team of dedicated phlebotomists, air fleet team, couriers and laboratory professionals, Quest Diagnostics works hard every day to help patients and communities across the United States access quality COVID-19 testing.

Outlook

In the $60 Billion and growing US Diagnostic Testing Market, Quest Diagnostics is the leader. Quest Diagnostics’ reputation as a leading innovator, provider of high value, low cost solutions and its financial strength and flexibility make it well positioned to capitalize on the evolving healthcare landscape.

Quest Diagnostics’ long-term strategy is to become the undisputed world leader in diagnostic testing, information and services. To drive this profitable growth, Quest Diagnostics plans to leverage capabilities to create differentiation:

•         Deliver Innovative Solutions

•         Leverage their Unparalleled Access and Distribution Network

•         Expand their relationships with large payors and health systems

•         Deliver Superior Patient Experiences

 

 

To Apply

Please Log In or Register to Upload a Resume and complete the online Application by visiting careers.questdiagnostics.com, clicking “Job Search” and following the prompts. Because of the large number of applicants to job openings, Quest Diagnostics will only contact qualified candidates for interviews.

Quest Diagnostics is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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