Job Responsibilities

Contribute during new product development and study documentation of the assigned studies. Apply and comply with clinical procedures for Good Clinical Practice (GCP) and all applicable regulations for sponsored studies conducted at participating sites.

• Manage the overall process for the conduct of the program sponsored R&D External Analytical or Clinical/ Performance study protocols.

• Prepare and/or review documents for submission/ essential study start-up as they relate to the assigned clinical/ performance evaluation studies (Clinical/ Performance study protocols, Informed Consent form, Investigator Brochure, Monitoring Plan, Laboratory Manual, Clinical Site Procedures, Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant documents) in accordance with GPC, and applicable international and regional/ country practices for privacy and protection of human subjects.

• Manage relationships with Investigator(s), site staff, collaborators, CRO and suppliers.

• Work cross functionally and may co-author with the R&D assigned associate writing the R&D External Analytical Study protocol(s). For clinical studies, develop study design, protocol draft and approval.

• Manage and/or support Ethics Review (IRB or EC) at the participating sites of the assigned study(ies).

• Monitor the Clinical study’s budget and study timeline, to ensure progress within approved parameters.

• Define, track and report schedule duration, interdependencies, milestones, critical path, efficiency and plan and staff effectiveness, and other key deliverables.

• Work cross-functionally with Core Team for site contracts, statistical analysis plan and data management to determine the data collection, recording, analysis, etc., as applicable.

• Oversee quality and content of the site staff training materials, provide input to authors for R&D External Analytical or Clinical/ Performance studies, as applicable.

• Communicate effectively with internal and external partners and stakeholders, manage real and potential risks that could compromise the metrics and progress of the study.

• Draft and submit for review and approval the clinical study report(s).

• Ensures the study trial master file is complete prior to GCP quality audit.

• Work effectively with clinical laboratory professionals, Ethics Committee or Institutional Review Board reviewers, and may manage Notified Body reviewers or Health Authority representatives, as needed.

• All other duties as assigned, including mentoring associate(s) with less experience.

Education and Experience

• Bachelor’s degree in relevant scientific discipline (Biological Sciences or Biomedical engineering focused on Biotechnology) or Advanced degree (e.g., MS, PhD, MPH, PharmD, MD) preferred.

• Minimum of 2 years of relevant industry experience in product and/or clinical development or a combination of equivalent education and experience, preferable with in-vitro diagnostics.

Skills and Knowledge

• Excellent verbal communication skills and ability to work effectively in a matrixial work environment required.

• Excellent written communication skills required to integrate critical documents: Protocols, Study Reports, submission packages for Institutional Review Board/ Ethics Committee review, as applicable.

• Highly organized, result and detail oriented, self-motivated with ability to take risks, willing to learn, experience with literature research method preferred.

• Working knowledge of MS Office, strong skills with MS Excel, reference management software (i.e., EndNote), PubMed/ Medline and/or database development.

• Knowledge of FDA regulations, In-Vitro Device Regulation (IVDR) and General Data Protection Regulation (GDPR).

Preferred Qualifications:

• Experience with BD Biosciences systems (BD FACSCanto™, BD FACSLyric ™, BD FACSDuet, BD LWA/SPA or LSR Fortessa™) and reagents preferred.

• Previous experience in clinical laboratory work.

• Experience using flow cytometric analysis software (FACSuite, Diva, FlowJo, etc.)

Travel

• Travel national and/or international up to 25%.

Work Environment

• Primary Work Location: Milpitas, CA

• Preferred hybrid work schedule.

*Relocation assistance will not be provided.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Required Skills

Optional Skills

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At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information