- Designing and implementing the clinical development strategy and clinical protocols and delivering high quality clinical programs, from first-in-human trials, through to full development.
- Serve as the therapeutic area lead of the development team, partnering closely with heads of development operations, pharmacovigilance, clinical quality, and biostatistics.
- Provide medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility, etc., and serve as primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies.
- Medical monitoring, coding, and data cleaning in collaboration with Clinical Operations.
- Ensure the medical integrity of clinical study reports and data interpretation/communication.
- Author or oversee authorship of clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represent the company at regulatory meetings including presentation at Advisory Committee Meetings.
- Preparing safety charters, DMC charters, or other specific management plans and manuals in a cross-functional team.
- Supporting or preparing data interpretation and clinical trial reports.
- Preparing Investigator Alert letters and SAE reports in collaboration with Clinical Operations as required.
- Represent the company to external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites, etc.
- Develop and manage budgets required to implement clinical development plans, and regularly report plan progress to stakeholders.
- Be an active participant with the corporate leadership team on the strategic direction of business and provide guidance on opportunities/hurdles that may be forecasted.
- Support business development, potential product evaluation, and due diligence.
- Provide medical/clinical expertise to internal (Marketing, Sales, Manufacturing, Managed Care, Regulatory Affairs, R&D, and Legal) and external (healthcare professionals, data safety monitoring boards, patients, advocacy groups, etc.) customers.
- Coach, manage, and mentor direct reports, while providing job enrichment and developmental opportunities.
- MD, PhD (Preferred), MD, DO, or foreign equivalent (Required)
- 10+ years of management experience in ophthalmology clinical development.
- Up to 20% travel expected.
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Executive Medical Director, Ophthalmology - Waltham, MA, United States - Apellis
Description
Job Description
Job Description
Position Summary:
The Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervising the clinical development team. This individual will be the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring of clinical studies, review & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data. This individual will play a crucial role in formulating the company's ophthalmology pipeline and portfolio expansion, working closely with the research and commercial departments.
Key Responsibilities Include:
Education, Registration & Certification:
Experience:
Travel Requirements:
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 to learn more.
Company Background:
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
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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