Clinical Affairs Manager III
Company: Bio-Rad Laboratories
Posted on: January 26, 2023
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
- 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
- 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
- Clinical laboratory experience is preferred.
- Extensive knowledge of FDA and CE Mark requirements including
Design Control Requirements.
- Clinical Research Professional Certification is
- Documentation and implementation of standards and
- Knowledge of clinical product labeling and export
- Experience preparing and reviewing clinical submissions
including FDA pre-market notifications, CE Technical
- 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
Keywords: Bio-Rad Laboratories, San Francisco , Clinical Affairs Manager III, Executive , Hercules, California
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