Director Clinical Operations – Siemens – Newark, DE

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

Join our team now at Siemens Healthineers as Director, Clinical Operations

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Director, Clinical Operations, you will be responsible for:

• You will direct the design, planning, execution, and interpretation of clinical trials/research and the data collection activities. You will work closely with counterparts in Data Management and Biostatistics in the development and refinement of processes related to clinical trials data collection and integrity.
• You will establish and approve scientific methods for design and implementation of clinical protocols, data collection systems, and final reports.
• You will be responsible in monitoring adherence to protocols, standard operating procedures and study completion.
• You will maintain good collaborations with premier scientists in the field, in order to identify outstanding questions that could impact ongoing clinical trials; as well as anticipate clinical education needs for new products. You will assist in developing the strategies for clinical trials.
• You will mentor Sr. Managers and Senior Clinical Research Associates on the product development process and effective representation at product development core teams.
• You will be responsible for the management of patient sample archives/biobanks related to clinical trials.
• You will be responsible for management and financial accounting of Siemens LD diagnostic systems at clinical trial sites.
• You will be responsible for identifying and establishing new clinical trial sites.
• You will lead the budgeting and resource planning necessary to support the Clinical Operations group.
• You will be responsible for reviewing all final Clinical Study Reports prior to regulatory submissions.
• You will collaborate with Regulatory Affairs and FDA or other regulatory and global (e.g. WHO, CDC) authorities regarding clinical research in support of product registration.
• You will demonstrate flexibility and the ability to change priorities to meet business needs and lead your team through these changes.
• You will demonstrate the ability to work in a diverse environment promoting workplace inclusion.

Required skills to have for the success of this role

• Bachelor’s degree in a scientific discipline with 14+ years relevant experience OR MS with 12+ years of relevant experience OR PhD with 6+ years relevant experience within medical device (IVD preferred), biotech, or pharmaceutical industry.
• Preferred requirement is Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology.
• Minimum of 4 years of People Management experience that including previous management experience leading scientific/clinical-based teams.
• Have a proven track record in acquiring FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in molecular diagnostics or immunodiagnostics.
• Must have demonstrated accomplishment in obtaining diagnostic product clearances/approvals through U.S. FDA, and successful audits/inspections of clinical evaluation sites.
• Knowledge of applicable clinical research/study regulations (FDA, GCP, ISO, IVDR).
• You will ensure that budgets, schedules, and performance requirements are met.
• Requires the ability and skills to influence others as part of conflict resolution/management.
• Willing to travel up to 20%.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.