We are currently searching for a skilled professional to join a well-known client's team as a Lab Director in New Brunswick, New Jersey. The Lab Director role will oversee the daily operations of the laboratory and its personnel ensuring testing is properly performed in accordance with Company policies, procedures, and applicable local, state, and federal laws, regulations, and requirements. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
Assist in the development/implementation of testing systems (policies and procedures) as required by state/federal regulatory agencies (CLEP, CLIA, and FDA)
Oversee laboratory performance, monitor initial implementation of new methods/systems, and resolve technical problems timely
Confirm laboratory implemented testing adheres to established/approved SOPs and quality control policies and is enrolled in an approved proficiency testing (PT) program
Implement performance improvement activities recommended by company policy and/or regulatory agencies
Address client inquires and problems professionally and expeditiously
Verify compliance with regulatory requirements of agencies
Monitor and maintain technical competency of technical personnel (annual competency evaluation and maintenance of licensure, certifications, competencies, and professional standing)
Act as a primary liaison between clinical laboratory administration, senior corporate management, laboratory staff, regulatory agencies, and others
Obtain NPI number and analogous registration numbers for reimbursement in worldwide markets
Lead clinical laboratory staff in the performance of their duties
Ensure laboratory safety procedures are rigorously observed and all employees are protected from physical, chemical, and biological hazards
Validate all qualified personnel receive the appropriate training and have demonstrated the ability to perform all testing procedures reliably and accurately
Provide constructive and timely performance evaluations
Maintain laboratory equipment and ensure all required maintenance records are up to date
Establish employee short and long-term goals, oversee implementation plans, and provide directions to meet these goals
Complete all required training on applicable aspects of the Company's test(s)
Minimum of 5 years of relevant experience required
Experience with oncology and molecular diagnostics
Minimum of 2 years of experience with LDT assays, Good Laboratory Practices (GLP), CMS CLIA, and NYSDOH CLEP regulations required
Experience with FDA LDT requirements, CAP accreditation, and EU equivalent standards/regulations preferred
Strong writing skills and ability to author documents, manuscripts for publications, SOPS, and clinical protocols
Experience with molecular biology techniques/assays and detailed understanding of real-time PCR analysis
Ability to identify, investigate, and resolve problems within the clinical laboratory
Knowledge of laboratory operations
Experience with laboratory/hospital information systems, implementation plans, and interfaces
Excellent verbal and written communication skills.
Strong analytical, organizational, and problem-solving skills
Proficient with Microsoft Office Suite or related software
Travel required - for training, meetings, etc.
Minimum of a current PhD degree in Oncology, Molecular Biology, or related field required
Current NYS CLEP Certificate of Qualification in the category of Oncology - Molecular and Cellular Tumor Marker required
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.