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Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases. Summary: The Medical Director of Ophthalmology reporting to the lead Medical Director of the therapeutic area will be responsible for medical monitoring in the relevant programs, including Phase 2 and 3 studies. This individual will monitor clinical studies, review and interpret clinical trial data, author clinical study and regulatory communications and reports, and monitor competitor activities.
Roles and Responsibilities:
- Provide sponsor medical oversight for assigned clinical trials
- Monitoring, coding and cleaning of clinical trial data, in collaboration with relevant members of the cross-functional clinical trial team, including Clinical Operations and Data Management
- Authoring clinical sections of regulatory documents including, but not limited to IND submissions, annual updates, study protocols, investigator brochures, briefing documents, and other study-relevant documents such as patient informed consent documents
- Providing clinical and scientific therapeutic area expertise and strategic insight to support clinical development in current indications, and to further identify additional development opportunities
- Writing manuscripts, publications, or other documents intended for external audiences
- Acting as an internal resource for clinical input and therapeutic area expertise
- Serving as the primary sponsor contact for clinical issues relating to assigned clinical trials
- Providing clinical and medical support to the CRO, as well as regulatory, safety and other functions, for assigned clinical trials
- Provide data interpretation, including in presentations, clinical trial reports and other documents, as needed
- Contribute to Strategic or Clinical Advisory Boards and,supporting Medical Affairs as needed
Requirements
- MD or DO degree (or international equivalent) with training in relevant therapeutic area
- Minimum of 5 years of industry-based clinical development experience in a pharmaceutical or biotechnology setting
- Experience initiating and managing clinical trials for industry
- Experience presenting complex medical data and concepts to a variety of audiences (medical, scientific, vendors) in a credible and engaging manner
- Ability to quickly develop a solid understanding of the clinical landscape relevant to patients and health care practitioners in the field
- Experience with ophthalmology devices or combination products, including familiarity with device-related clinical trial design, regulatory considerations, and post-market clinical evidence generation.
- Exposure to digital health technologies or AI-enabled tools in ophthalmology, including imaging analytics, image-based endpoints, biomarker development, clinical decision support, or real-world data applications.
- Familiarity with ophthalmic imaging modalities (e.g., OCT) and their use in clinical trials, including endpoint selection and data interpretation.
- 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
- Capable of proactively seeking out and recommending process improvements
- Entrepreneurial, enjoys working in a fast-paced, small-company environment
- Must enjoy and function well as part of a multi-functional team
- Proven ability to multitask, prioritize and execute corporate objectives and goals
- Ability to operate autonomously in a fast-paced company
Travel Requirements: Travel Requirements: None
Education: Doctorate Degree
Pay Information: Base salary for this role will consider multiple factors, including but not limited to, candidate qualifications, relevant expertise, specialized skills, and industry experience in complement-targeted therapies. The targeted base salary range for this position is $253,000-$379,000. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions.
Work Arrangement: Benefits and Perks:
Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit https://apellis.com/careers/benefits/ to learn more.
Company Background:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. We believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, please visit http://apellis.comor follow us on LinkedIn andX. EEO Statement:
Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law. For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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