Senior Director, Oncology Laboratory Operations

San Diego, CA, United States

Biotheranostics , a Hologic company, develops and provides molecular-based diagnostic, prognostic, and predictive tests that support physicians in the treatment of cancer patients. It serves as the organization’s hub for oncology.

The Senior Director, Laboratory Operations will be responsible for leading and expanding the functions and infrastructure of the clinical lab to manage increased test volume and to provide increased testing capabilities we drive growth.

They are also responsible for building an engaged and performance-oriented culture and team, with a focus on effectively serving our patients.

This is a full-time San Diego office-based position.

Responsibilities:

• Developing and implementing a strategic plan to industrialize operations to align with growing commercial demand, including the design and execution of validation testing to guarantee robust processes.

• Managing the financial performance of the laboratory, including budgeting and planning for all clinical lab departments.

• Identifying and implementing the appropriate strategies for reducing costs and improving the quality of services

• Assessing laboratory unit operations considering corporate strategies, the Company’s Corporate Compliance Program, and identifying and implemeting operational improvements.

• Defining and coaching teams to the achievement of Corporate and Laboratory Operations Goals

• Developing and implementing Standard Operating Procedures in the clinical laboratory.

• Planning and oversight of CLIA lab facility expansions.

• Leading the clinical laboratory team, including recruitment, retention, training and development, performance management, employee relations, and the development of team-oriented culture within and between departments.

• Partnering with the laboratory personnel to ensure adherence to established procedures and quality checks for all phases of testing, including the pre-analytic, analytic, and post-analytic phases of testing as well as general laboratory systems.

• Partnering with Regulatory and Quality Assurance personnel to execute and maintain a Quality Management System (QMS) compliant with CLIA regulations (42CFR493), College of American Pathologists (CAP) checklists, and applicable state and federal regulations).

• Partnering with the Laboratory Management to ensure policies and procedures are established for hiring and monitoring individuals who conduct testing to assure they have the appropriate education and experience, are competent, and maintain their competency to perform the testing procedures.

• Troubleshooting problems as they affect clinical operations.

• Working with laboratory staff, client services, sales representatives, vendors, and clients to resolve operational or technical issues.

• Acting as primary liaison between lab departments and other departments within the company.

• Serving on various committees including the Corporate Compliance Committee.

• Working with the quality team to compile and analyze trending and statistical reports for the clinical lab to present to management. Participating in the strategic planning process.

• Prepare for and lead the transition into the FDA oversight of Lab Developed tests.

• Oversee implementation of IT initiatives including LIS implementation and EHR integration.

Education and Experience Requirements

Required:

• Bachelor’s Degree

• Minimum of (5+) years of management experience, leading teams of 20 or more.

• Strong technical knowledge of molecular biology and molecular testing laboratory practices (CLIA, CAP, NYDOH).

• Articulate and effective communicator (both written and verbal).

• History of working with licensed pathologists and the Laboratory Directors in a clinical laboratory setting.

• Proven, dynamic leader with strong interpersonal and management skills who can work effectively at all levels of an organization and deliver results.

• Demonstrated ability in operationalizing vision and success in executing strategies that support business initiatives.

• Customer-focused with the ability to build strong collaborative relationships with business unit heads and functional managers.

• Possesses a broad understanding of how to leverage the capabilities of human capital to produce winning strategies to achieve results for the clients served.

• The ability to influence across boundaries and be viewed as a leader in Laboratory Operations.

Preferred:

• Licensed California Clinical Laboratory scientist (meets California Department of Public Health/CLIA requirements for licensure for high complexity testing).

• Advanced scientific degree, with (10+) years of industry experience in a laboratory services company

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

From a benefits perspective, you will have a access to benefits such as medical and dental insurance, ESPP, 401(k) plan, vacation, sick leave and holidays, parental leave, wellness program and many more!

The annualized base salary range for this role is $195,200 to $346,900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third-Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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