Director, Clinical Affairs

About the Role

We are looking for a Director of Clinical Affairs to join our team. In this role, you will provide leadership in the strategic planning, implementation, support, and completion of US and OUS pivotal clinical studies to achieve regulatory needs and marketing objectives for Gore Ophthalmic products worldwide. Their initial focus will be supporting the GORE Glaucoma Drainage Implant (GDI) and GORE Synthetic Cornea Device (SCD). They will oversee all aspects of clinical trial management, development, and operations.

This is a remote position, and you can work from home in most locations within the United States. 

Responsibilities

• Provide project and or CRO management and assure successful conduct of assigned clinical trials consistent with Research and Development plans, Marketing plans, applicable regulations and company policies and procedures
• Assist in identification of clinical study strategies and investigators to support regulatory submissions and marketing requirements
• Develop and conduct surgical training plan for Investigators with other clinical consultants. Maintain oversight from orientation sessions, international training, dry lab and proctoring of cases
• Contribute to the development of clinical protocols, informed consent, and data collection forms as well as clinical site study material, and other clinical documents associated with the protocol.
• Vendor management for IRB, Endothelial Cell Counts, Specular Microscopes and other protocol specific study supply needs
• Manage clinical trial start-up activities including investigator identification, shipment of clinical study supplies and investigational product, and collection of in-house clinical study files
• Oversee the training of study site personnel on the investigational product, clinical protocol, and clinical trial responsibilities
• Work with clinical data manager and statistician to update and maintain clinical databases and produce clinically sound, reliable data
• Maintain compliance of conducted studies with domestic regulations pertaining to medical devices for regulatory submissions, institutional review boards (IRB), clinical investigations, monitoring procedures, and medical device reporting
• Attend courses, seminars, meetings, as required

Required Qualifications

• Bachelor’s degree in biological/health sciences or equivalent, including relevant clinical research experience
• A minimum of 18 years relevant work experience in medical device with experience in surgical ophthalmology and medical devices
• Knowledge of the operating room environment, sterile technique, and decorum
• Knowledge of medical terminology and ophthalmology terminology
• Exceptional problem-solving skills and ability to institute corrective measures, strong oral and written communications skills and excellent interpersonal skills
• Self-motivated leader able to manage and motivate site research teams, establishing goals; monitoring results and achieve goals
• Strong sense of teamwork, ability to influence others and build collaborative relationships
• Highly proficient in software applications such as Word, Excel, and PowerPoint with the ability to learn other computer software, as required
• Ability to travel up to 50%, including international travel

Desired Qualifications

• A degree in biological sciences
• Experience in surgical glaucoma plus cornea device trials
  
• Knowledge of the applicable devices and team