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Clinical Affairs Manager III

Company: Bio-Rad Laboratories
Location: Hercules
Posted on: January 26, 2023

Job Description:

Provides clinical affairs and clinical data management leadership of US and Europe teams to support the development of IVD clinical trial protocols, data collection and report preparation for regulatory submission; assures relevant requirements are fulfilled. Leads implementation of multiple US and Europe clinical trials and ensures compliance with study protocols, good clinical practice (GCP). ICH/FDA/EU regulations, guidance and department training instructions. Communicates and interacts with clinical investigators to implement and assure reliable clinical trials; negotiates clinical studies cost with investigators following management guidelines. Keeps management informed of clinical trial progress, issues, and department projects and planned activities; attends project team meetings and makes presentations as required. Manages, reviews, and motivates department staff to maximize available resources and to attain department and company goals. Plans, organizes and supervises the work of assigned employees; assures maximum utilization of skills, equipment and materials, consistent with company goals and schedules.Responsibilities

  • Oversees 3-8 direct reports, including Clinical Affairs Managers, CRAs, Clinical Data Specialists.
  • Responsible for the departmental budgeting.
  • Communicates and interacts with clinical investigators to implement and assure reliable clinical trials; negotiates clinical studies cost with investigators following management guidelines.
  • Recommends clinical departmental improvements and provides corrective action plans.
  • Acts as a resource for strategic planning for regulatory submissions including Europe notified body and/or US FDA Pre-Sub, 510(k), or PMA with CDRH/OIVDR and CBER.
  • Develops and leads the execution of clinical strategy for regulatory requirements and submissions.
  • Participates in Pre-Sub meetings interfacing for the business segment.
  • Oversees domestic and international clinical trial groups.

    • Bachelor's degree or equivalent in a related field.
    • Advanced Degree preferred.
    • 10+ years relevant Clinical experience [including IVD], with supervisory experience, or equivalent combination of education and experience.
    • Clinical laboratory experience is preferred.
    • Extensive knowledge of FDA and CE Mark requirements including Design Control Requirements.
    • Clinical Research Professional Certification is preferred.
    • Documentation and implementation of standards and regulations.
    • Knowledge of clinical product labeling and export regulations.
    • Experience preparing and reviewing clinical submissions including FDA pre-market notifications, CE Technical Documentation.
    • Communication, public-speaking, decision-making, word processor, spreadsheet, and negotiation skills.
    • Strong customer orientation and focus.
      Vaccination Requirement: Ability and consent to upload proof of completed Covid-19 vaccination into our secure database within 3 days of start date.Total Rewards Package:At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.Benefits:We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance.Compensation:The estimated base salary range for this position is $165,700 to $227,800 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.Who We Are:For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.Agency Non-Solicitation:Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Keywords: Bio-Rad Laboratories, San Francisco , Clinical Affairs Manager III, Executive , Hercules, California

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