I'm currently partnered with a growing global pharmaceutical organization who is looking to add a Head of Ophthalmology, Clinical Development to their team!
Reporting directly to the VP of Clinical Development and working closely with the leadership team to define clinical and medical strategy and be accountable for global clinical projects. You will be responsible to build and strategize upon the exciting pipeline of phase I-III trials in the ophthalmology space for one or more IPs, and steer with the responsible team members within the medical and clinical department, and cross-functional matrix.
The ideal candidate has extensive experience with ophthalmology clinical trials phase, FDA submissions and bilingual in Mandarin (not required).
RESPONSIBILITIES
- Responsible for clinical development strategies, including Phase I through III, life cycle management, safety responsibilities, scientific interactions with regulatory bodies, and interactions with cooperate partners.
- Leads and oversees the strategic definition and tactical development of clinical trials programs, including protocol, interpretation of clinical data, and literature reviews.
- Ensures that all clinical trials are in keeping with approved timelines and budgets, with potential obstacles identified and solution implemented to avoid delays in clinical trials implementation.
- Ensures that clinical trials are conducted in accordance with applicable regulatory requirements and guidelines.
- Be a critical element in company's approach to create an effective bridge between discovery research and clinical development.
- Keep upper management informed of key opportunities, benefit/risk issues for the assigned therapeutic areas.
- Participates and active member of the executive team of the company. May carry the duty of presenting status, progress, and differentiation of our pipeline to board and other potential investors.
REQUIREMENTS
- D or Ph.D. in Clinical Medicine and at least 5+ years of broad bio/pharmaceutical industry experience in drug development.
- Experience in ophthalmology therapeutic specialty.
- Pharmaceutical industry experience in the successful development, registration and commercialization of new drug products is preferred.
- Experience in pharmaceutical or biotech industry working with Phase I - III clinical trials, and/or serving as principal investigator with a background in clinical trial design and protocol development.
- Independent, self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive management style.
