Manager, Clinical Science – QuidelOrtho

Job Description

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow, we are seeking a Manager, Clinical Science in the Clinical Affairs department. The Manager, Clinical Science under the supervision of the Sr. Manager of Clinical Affairs, leads the planning and oversight of clinical development activities to support the validation of assigned assays. This position is responsible for interpreting medical, scientific and clinical strategy and driving clinical development and study management of multiple moderate to highly complex clinical programs including, but not limited to, the planning, implementation, oversight, project management and completion of clinical studies conducted by Clinical Affairs or Contract Research Organizations (CRO). The Manager, Clinical Science serves as a subject matter expert for clinical studies and serves as a mentor for Clinical Affairs staff. He/she will drive results through inspired leadership with a focused and disciplined approach to clinical development that is consistent with best practices in the industry.

This is a remote position that can be worked from anywhere in the US.

The Responsibilities
• Independently plans and executes clinical studies and leads cross-functional teams responsible for the planning, execution, analysis and reporting of assigned clinical performance studies. Applies expertise in clinical data review and statistical analysis. Reviews and approves clinical designs, protocols and summary reports. Ensures that assigned Clinical Affairs staff and contractors have appropriate knowledge of relevant analyzer and assay technologies. Represents Clinical Affairs in cross-functional Program Management Teams.
• Independently develops and presents program strategies to ensure that the clinical programs effectively achieve the overall assay product development program objectives within approved budgets and committed timelines and in compliance with all relevant laws, regulations, guidelines and internal policies & SOPs. When necessary, presents and defends clinical study designs, procedures and data analysis to regualtory authorities. Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff.
• Evaluates and statistically analyzes data that is clinically/scientifically sound to confirm or deny performance claims supporting regulatory submissions and to ensure that the product conforms to defined user needs and/or requirements. Authors clinical summary reports and technical documents and summarizes clinical performance data for product labeling. Contributes to the authoring of presentations and publications of clinical study data
• Identifies, qualifies, selects and manages external service providers responsible for multi-million dollar budgets. Responsible for management of vendor performance to ensure adherence to scope of work within timelines and budget at a task level. Proactively assesses potential risks to the study and proposes mitigation plans
• Provides cost and staffing estimates for clinical projects, ensuring appropriate input from the functional teams responsible for the conduct of assigned studies. Participates in establishing and tracking of assigned study budgets and staffing plans in the BERT system. Hire, train and evaluate staff.
• Participates in the development and maintenance of SOPs and/or initiatives and departmental coaching/ mentoring for the development of clinical personnel.
• Supports company cross-functional strategic business integration and process improvement initiatives and special projects.

The Individual

Required:
• Bachelor of Science required in medical, biological, or closely related science or medical specialty.
• Minimum 7 years of direct clinical study experience, (e.g., IVD, pharmaceutical, medical device, CRO) of which a minimum of 2 years must include clinical study design responsibility required.
• Minimum of 2 years of IVD clinical study experience including the proven ability to oversee clinical teams in the conduct and report of multicenter, complex studies is required.
• At least 2 years of demonstrated individual/team supervisory and management experience is required.
• Must be able to work both independently and within a cross-functional team environment.
• Must be skilled in common computer programs, e.g., word processing, graphics, spreadsheets.

Preferred:
• Clinical Laboratory Scientist certification [MT/MLS (ASCP) or equivalent] preferred. Master’s degree preferred.
• Budgetary experience is preferred.

The Work Environment
• Typical office environment. However remote work may be part of this employment.
• Up to 100% of time at desk, standing or sitting extended periods of time.
• Flexible work hours to meet project deadlines.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $88,000 to $176,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

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