My job alerts

Clinical Operations Inspection Lead

Tubulis Technologies

Operations

Munich, Germany · Germany · Bavaria, Germany

Posted on Mar 4, 2026

Be part of our team

As a highly skilled and detail-oriented Clinical Operations Inspection Lead you will oversee and manage inspection activities across our global clinical trials. The ideal candidate will ensure compliance with regulatory requirements, Good Clinical Practice (GCP), and internal standards while leading inspection readiness initiatives. This role requires strong leadership, excellent analytical skills, and the ability to collaborate effectively across cross-functional teams.

This position is available in the Boston metro region as well as the following remote locations: MA, NY, PA, RI, NJ, MD, NC, and FL. Please only apply if you are located in one of these states.

Your mission

Lead and coordinate inspection readiness activities for clinical trials, ensuring adherence to regulatory standards (FDA, EMA, ICH-GCP).
Serve as the primary point of contact for regulatory inspections related to clinical operations.
Develop, implement, and maintain inspection-related SOPs, checklists, and training programs.
Conduct gap assessments to prepare sites, vendors, and teams for inspections.
Provide guidance and mentorship to clinical operations staff on inspection processes and expectations.
Track inspection outcomes, generate reports, and implement corrective and preventive actions (CAPA).
Collaborate with cross-functional teams, including QA, Regulatory Affairs, Clinical Project Management, and Data Management.
Stay updated on evolving regulatory requirements and inspection trends to ensure compliance.

Your profile

Bachelor’s degree in Life Sciences, Nursing, or a related field; advanced degree preferred.
Minimum of 5 years of experience in clinical operations, quality assurance, or regulatory inspection roles.
Strong knowledge of GCP, FDA, EMA, and other applicable regulations.
Proven experience preparing for regulatory inspections.
Excellent leadership, communication, and project management skills.
Ability to work independently and drive initiatives in a fast-paced environment.
Experience with global clinical trials and multi-site inspections.
Knowledge of electronic trial master file (eTMF) systems.
Oncology experience is a plus

Why us?

At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast-growing biotech where science meets passion—and where you have the chance to grow with us.

Impact that matters: Contribute to breakthrough therapies.
Global mindset: Work in an international, diverse team.
Grow & thrive: Develop your career in a supportive, fast-moving environment.
Innovation every day: Push boundaries with cutting-edge science.

At Tubulis, your ideas matter, your growth matters—and together, we make a difference.

Apply for this job

About us

Tubulis is a clinical stage biotech company that generates uniquely matched antibody-drug conjugates (ADCs) with superior biophysical properties that have demonstrated durable on-tumor delivery and long-lasting anti-tumor activity in preclinical models. We recently closed on a Series C fundraising round totaling €344M (US $401M).

The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and ADCs. With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.

See more open positions at Tubulis Technologies

Privacy policy Cookie policy

Portfolio Jobs

Browse through our portfolio jobs and select a suitable opportunity.Our HTGF Portfolio of startups offers excellent opportunities and is always hiring talented people.