Stryker

Director Clinical Operations

Posted on: 19 Jan 2021

Mahwah, NJ

Job Description

Responsibilities and duties

Participate in the development and execution of Joint Replacements clinical strategy to support Stryker sponsored research.

Partner with the R&D and Commercial teams to ensure strategic alignment and timely execution of research strategy, including market access, and product performance.

Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports.

Ensure compliance to FDA, MDR and other health authority regulations, company policies and SOPs for Stryker and investigator initiated clinical research.

Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements.

Represent Stryker as an industry leader within industry trade and clinical research organizations. Provide leadership and strategy to influence the regulatory environment affecting the medical device/orthopedic industry.

Provide strategic oversight and review of regulatory submissions, technical communication and marketing materials regarding clinical data.

Develop, staff, and lead the Clinical Operations team to ensure effective and efficient attainment of clinical operations goals.

Stryker

Kalamazoo, MI

Stryker Corporation operates as a medical technology company. The company operates through three segments: Orthopaedics, MedSurg, and Neurotechnology and Spine. The Orthopaedics segment provides implants for use in hip and knee joint replacements, and trauma and extremities surgeries. The MedSurg segment offers surgical equipment and surgical navigation systems, endoscopic and communications systems, patient handling, emergency medical equipment and intensive care disposable products, reprocessed and remanufactured medical devices, and other medical devices for use in various medical specialties.

The Neurotechnology and Spine segment provides neurotechnology products that include products used for minimally invasive endovascular techniques; products for brain and open skull based surgical procedures; orthobiologic and biosurgery products, such as synthetic bone grafts and vertebral augmentation products; and minimally invasive products for the treatment of acute ischemic and hemorrhagic stroke. It also provides spinal implant products comprising cervical, thoracolumbar, and interbody systems for use in spinal injury, deformity, and degenerative therapies.

The company sells its products to doctors, hospitals, and other healthcare facilities through company-owned subsidiaries and branches, as well as third-party dealers and distributors in approximately 80 countries. Stryker Corporation was founded in 1941 and is headquartered in Kalamazoo, Michigan.