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Clinical Development Leader
2 months ago
Astellas Pharma Inc. is seeking a highly motivated and experienced Clinical Development Lead, Ophthalmology to join our growing team. In this role, you will play a pivotal part in the development of innovative therapies for patients with eye diseases.
The Clinical Development Lead will be responsible for leading global clinical development programs from design through regulatory submission. You will work closely with cross-functional teams including Regulatory Affairs, Commercial, Medical Affairs, Manufacturing, Clinical Pharmacology, Statistics, Health Economics and Outcomes Research to ensure the successful execution of clinical trials.
Responsibilities- Lead the development and implementation of multi-phase clinical studies globally to support regulatory submissions for new ophthalmic therapies.
- Collaborate with internal stakeholders and external partners to design, conduct, and manage clinical trials in accordance with ICH/GCP guidelines.
- Oversee the medical monitoring strategy and ensure timely escalation of potential safety signals and concerns.
- Develop and maintain strong relationships with key opinion leaders and investigators in the field of ophthalmology.
- Contribute to the development of clinical trial protocols, investigator brochures, study reports, and regulatory submissions.
- Present clinical data at scientific conferences and meetings.
- Stay abreast of current trends and advancements in ophthalmic drug development.
- Medical Degree (or Medically Qualified) with completion of residency in Ophthalmology with active or prior Board Certification.
- Minimum 8 years of relevant experience in drug development within a biotech/pharmaceutical company or equivalent experience in an academic clinical research institute.
- Proven track record of success in leading and managing clinical development programs.
- Excellent communication, interpersonal, and presentation skills.
- Strong understanding of ICH/GCP guidelines and other applicable regulatory requirements.