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    Medical Director Health Services - Waltham, MA, United States - Apellis

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    Description
    The Medical Directorof 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.

    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 andsupport Medical Affairs as needed.
    3+ years of experience in industry-based clinical development and preferably some phase III clinical trial experience.

    Must have prior experience in ophthalmology.
    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.
    Proactively seek out and recommend process improvements.
    Demonstrated application of critical thinking skills.

    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.

    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 Apellis Pharmaceuticals, Inc.

    is a global biopharmaceutical company that combines courageous science and compassion 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 approved medicines targeting C3.

    These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world.

    With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

    For more information, please visit or follow us on Twitter and LinkedIn

    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.



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