Executive Medical Director Ophthalmology
Executive Medical Director Ophthalmology
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Salary Not Disclosed
1 Vacancy
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 companys ophthalmology pipeline and portfolio expansion working closely with the research and commercial departments.
Key Responsibilities Include:
- Designing and implementing the clinical development strategy and clinical protocols and delivering high quality clinical programs from firstinhuman 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 crossfunctional 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.
Education Registration & Certification:
- MD PhD (Preferred)MD DO or foreign equivalent (Required)
Experience:
- 10 years of management experience in ophthalmology clinical development.
Travel Requirements:
- Up to 20 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/careers/ to learn more.
Company Background:
Apellis Pharmaceuticals Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop lifechanging 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 preclinical programs underway we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information please visit follow us onTwitterandLinkedIn
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.
Required Experience:
Director
Employment Type
Full Time
