Director, Clinical Affairs

About the Role

We are looking for a Director of Clinical Affairs to join our team. In this role, you willprovide 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.

Pay and Benefits:

• $220,000 to $240,000per year
• Roles above $150k are eligible for the variable pay program each fiscal year, based on defined business performance metrics.
• Factors considered in extending an offer within this pay range include (but not limited to) education, experience, knowledge, skills, and abilities.
• Medical, Dental and Vision benefits effective on Day 1 of employment! We offer a comprehensive total rewards package, including competitive benefits. More details are available at

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

What We Offer

Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits

Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.

This position offers a remote work arrangement in the country from which the Associate is employed.Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.

*Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.