Medical Director

Position Summary:

The Medical Director of Ophthalmology will be a key contributor to the Ophthalmology Program at Apellis. This position will have oversight of the clinical studies in Geographic Atrophy, and potentially participate in clinical development activities for future indications. This individual will be responsible for monitoring clinical studies, review and interpret clinical trial data, author clinical study and regulatory communications. 

Key Responsibilities Include:

• Provide sponsor medical oversight for ophthalmology clinical studies. 
• Medical monitoring, coding, and data cleaning in collaboration with clinical operations and data management.
• Serve as the primary point of contact for clinical trial staff at study sites for clinical issues as well as regulatory, safety and other functions. 
• Author clinical sections of regulatory documents including study protocols, investigator brochures, briefing documents, annual updates, and other study-relevant documents such as patient informed consent documents. 
• Supporting or preparing data interpretation and clinical trial reports. 
• Acting as an internal resource for functions requiring clinical input and ophthalmology expertise.  
• Write manuscripts, publications, or other documents intended for external audiences. 
• Contribute to clinical advisory boards and support Medical Affairs as needed. 

Education, Registration & Certification:

• 3+ years of experience in industry-based clinical development and preferably some phase III clinical trial experience. 

Experience:

• Must have prior experience in ophthalmology. 
• Experience in retinal disease is a plus. 
• Experience initiating and managing or participating in clinical trials for industry. 
• Experience presenting medical data and concepts to a variety of audiences (medical, scientific, vendors) in a credible and engaging manner. 
• Solid understanding of the clinical landscape relevant to patients and health care practitioners in the field.
• Strong technical/analytical skills to identify and solve problems.
• Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
• Proven ability to work with a high level of integrity, accuracy, and attention to detail.
• Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
• Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships.
• Proactively seek out and recommend process improvements.
• Entrepreneurial, enjoys working in a fast-paced, small-company environment.
• Demonstrated application of critical thinking skills.
• Proven ability to multitask, prioritize and execute corporate objectives and goals.
• Ability to operate autonomously in a fast-paced early phase company. 

Physical Demands and Work Environment:

• This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 30% travel expected. 

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit https://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company