Senior Director, Clinical Quality Risk Management

Senior Director - Permanent - Cambridge, MA

Proclinical is seeking a Senior Director, Clinical Quality Risk Management to join and lead a growing team in Cambridge, MA.

Primary Responsibilities:

The successful candidate will focus on designing and leading a comprehensive clinical quality risk management framework to ensure the highest standards of compliance, patient safety, and operational excellence across global clinical trials. You will collaborate with cross-functional teams to proactively identify, assess, and mitigate risks while embedding risk-based approaches into clinical trial operations.

Skills & Requirements:

• Advanced degree in Life Sciences (e.g., MS, PharmD, PhD, MD) or equivalent preferred.
• Expertise in GCP, ICH E6(R3), ICH Q9(R1), FDA, EMA, and other global regulations.
• Proven experience in developing and implementing risk-based clinical quality systems.
• Strong leadership, collaboration, and communication skills in a matrixed environment.
• Experience in oncology and/or biologics is highly desirable.
• Demonstrated success in regulatory inspection preparation and participation as a clinical quality subject matter expert (SME).

The Senior Director's responsibilities will be:

• Develop and execute a robust Clinical Quality Risk Management strategy.
• Collaborate with study teams to identify critical data and processes, ensuring effective risk assessments and continuous improvement.
• Establish tools and metrics to track and review risks, identifying trends and gaps for resolution.
• Provide expert guidance to senior leadership on emerging clinical risks and mitigation strategies.
• Represent Clinical Quality in governance meetings and cross-functional forums.
• Drive integration of risk-based approaches into Quality Management Systems (QMS), vendor oversight, and clinical trial operations.
• Facilitate risk workshops and support quality-by-design initiatives.
• Provide training and coaching to internal teams and external partners on clinical quality risk management.

Compensation:

• $270 000.00 - $290 000.00 Per Annum

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at [email protected]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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