6 часов назад
Director, Clinical Scientist - Ophthalmology
197 760 - 249 947$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Clinical Scientist - Ophthalmology (Clinical Development): Developing and supporting global clinical trials for innovative retinal disease therapies with an accent on ophthalmology, safety, data integrity, and regulatory compliance. Focus on designing clinical trial documents, reviewing clinical data, supporting regulatory submissions, and driving recruitment and study milestones across cross-functional teams.
Location: Remote within the United States; company address: Watertown, Massachusetts, United States
Salary: $197,760–$249,947 USD per year
Company
is an ophthalmology company developing and commercializing innovative therapeutics for serious retinal diseases and blindness prevention.
What you will do
- Implement Clinical Development Plans and registrational strategies for assigned products in collaboration with cross-functional teams.
- Develop and review clinical trial documents, including protocols, investigator brochures, informed consent templates, case report forms, procedure manuals, and clinical study reports.
- Manage the collection, review, and analysis of clinical trial data, including ongoing assessment of safety, effectiveness, and protocol adherence.
- Prepare clinical materials for regulatory submissions and meetings, including EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDA, and MAA activities.
- Support site initiation, monitoring plans, investigator meetings, recruitment strategies, and enrollment performance.
- Track study milestones and metrics and ensure global trials comply with ICH, GCP, and applicable regulatory requirements.
Requirements
- Advanced degree in a life science, clinical, or medical field; PhD or PharmD.
- Minimum of 10 years of clinical development, clinical research, and R&D experience preferred.
- Experience in ophthalmology and familiarity with drug-device combination products.
- Experience across all phases of clinical drug development, including regulatory submissions.
- Strong understanding and application of clinical research procedures and Good Clinical Practice standards.
- Strong communication, organizational, interpersonal, analytical, and independent decision-making skills, with experience in matrix and cross-functional teams.
Culture & Benefits
- Remote work arrangement.
- Culture focused on transformational innovation, integrity, compassionate excellence, and inclusive collaboration.
- Work is centered on developing vision-preserving treatments for patients with serious retinal diseases.
- Equal opportunity employment and commitment to diversity and inclusion.
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