
Clinical Director
2 days ago
We are seeking a highly experienced and skilled Senior Leader to oversee our clinical strategy and development for a pipeline of novel biopharmaceuticals and complex biosimilars. The ideal candidate will have a strong background in pharmacology and experience in leading global clinical development programs.
Key Responsibilities:- Develop comprehensive clinical development strategies for preclinical/clinical assets, aligning with regulatory and commercial objectives.
- Design study protocols ensuring robust study designs (endpoints, patient populations, adaptive methodologies) that meet US FDA, EMA, and ICH guidelines.
- Collaborate with executive leadership to ensure integrated planning.
- Identify opportunities for innovation in trial design, biomarkers, or patient recruitment strategies.
- Coordinate with external stakeholders such as CROs, KOLs, and clinical investigators.
- MD in Pharmacology/Medicine or related field; board certification preferred.
- 15+ years in clinical development, including 5+ years in leadership roles at biopharmaceutical companies.
- Proven success in global NDA/MAA submissions for biologics/biosimilars.
- Expertise in ophthalmology, metabolic disorders, or maternal-fetal therapeutics.
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