Medical Director (Ophthalmology)
Exclusive opportunity ARTO is excitedly partnered with a leading global Biotech company to source a Medical Director focused on early phase (phase1 / phase 2 / phase3) in ophthalmic clinical development.
Remote, available global pathways, California USA.
As the Medical Director, you will provide medical and scientific input to preclinical and clinical stage assets, taking responsibility for clinical development in an individual contributor role to support early phase clinical development activities.
These include the creation of overall clinical development plans and clinical study design, as well as writing protocols, key study and health authority documentation.
Crucially, you will be responsible for medical monitoring and protocol design , delivery and interpretation of clinical studies, ensuring the ethical and scientific integrity of the plans, studies and product in compliance with GCP.
You will be an individual contributor.
The successful candidate will thrive in a fast-paced, proactive can-do culture, be a strong communicator and collaborator.
My client is looking for a passionate, entrepreneurial personality. They will ensure design and delivery of clinical development plans with high quality and speed.
Key Responsibilities :
Clinical Oversight :
Ensure high-quality, timely clinical submissions and successful commercialization.
Partner with cross-functional teams on clinical strategy and budget planning.
Monitor and adjust clinical research plans to meet objectives.
Regulatory & Compliance :
Maintain compliance with local and international regulations and company policies.
Support global registrations, labelling, and regulatory issue resolution.
Scientific & Technical Expertise :
Stay updated on scientific developments and competitive products.
Provide oversight for protocol development and informed consent documents.
External Collaboration :
Interact with consultants, opinion leaders, and regulatory agencies.
Represent the medical team in business and regulatory discussions.
Requirements :
Medical Doctor of Ophthalmology . Must be board eligible or certified in appropriate specialty / subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
Phase 1 / Phase 2 / Phase 3 Clinical Development Experience.
Minimum 2-years industry experience in sponsor side clinical development.
Strong understand of the Ophthalmology therapeutic area. Previous experience specifically working in ophthalmic drug development would be desirable.
No leadership experience needed.
If you'd like to learn more about this opportunity, please reach out and I'll be happy to have a confidential discussion in more detail over a call.