Vice President Clinical Development
4 weeks ago
**Vice President of Ophthalmology Clinical Development**
My client are looking to expand their ophthalmology drug development programs. The successful candidate will play a critical role in setting the strategic direction for clinical development initiatives, overseeing multiple projects from preclinical through to Phase III, with a particular focus on retinal diseases. This leadership position requires a deep understanding of clinical development, a track record of regulatory success, and experience in managing complex, cross-functional teams.
Key Responsibilities:
- Strategic Leadership: Define and implement the clinical development strategy for ophthalmology, aligning with overall business goals.
- Clinical Oversight: Lead end-to-end clinical programs, ensuring effective design, execution, and completion of clinical trials (Phases I-IV).
- Regulatory Management: Drive regulatory strategy and manage interactions with global regulatory authorities to achieve timely approvals.
- Cross-functional Collaboration: Partner with R&D, Medical Affairs, Commercial, and Regulatory teams to support clinical and business objectives.
- Budget and Resource Management: Oversee program budgets, allocate resources efficiently, and ensure cost-effective program execution.
Qualifications:
- Experience: 10+ years in clinical development with a focus on ophthalmology or retinal diseases
- Leadership: Proven ability to lead large, cross-functional teams and manage complex, multi-center trials.
- Regulatory Expertise: Extensive experience with FDA/EMA regulations and proven success in regulatory submissions (IND, NDA, BLA).
- Education: MD or PhD preferred; other advanced degrees considered with significant experience
Please note: We do NOT need medical affairs people
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