Clinical Trial Physician Job, Benelux Region

Reference No: J6343

Clinical Trial Physician Job, Benelux Region

The role

Our client is a growing biopharmaceutical organisation that has just published results on pivotal phase III clinical trials. Because of these positive results, and a commercialisation agreement with a major pharmaceutical partner, our client is looking to build a significant Ophthalmology franchise. The first step in this process is to hire a Clinical Trials Physician.

You will have responsibility for all aspects of clinical study design, implementation and reporting:

•Provide clinical input into development programmes
•Lead efforts in protocol writing, all aspects of carrying out clinical trials, data analyses, writing study reports
•Work with the study team ensuring the clinical aspects of protocol are carried out
•Develop or approve monitoring plans
•Oversee feasibility assessment and investigator/site selection
•Interaction with and management of CRO and other vendors
•Manage and assist with Competent Authority and Ethics Committee/IRB submissions
•Assist with and supporting patient recruitment tactics and processes
•Ensure compliance procedures and SOPs are followed
•Present data to internal and external stakeholders
•Be the primary contact for medical review of safety reports in pharmacovigilance.
•Provide clinical interpretation of safety data
•Contribute to development of safety planning for studies incl. Post Marketing authorisation studies & ISS
•Contribute to the design of Risk Management plans
•Help with any regulatory/submission issues
•Mentor Clinical Project Managers

The candidate profile

•Minimum 5 years experience in Clinical Development in the biopharmaceutical industry
•You will have experience in the field of Ophthalmology
•You will be a Medical Doctor (MD)
•Experience leading and managing project teams and coordinating and managing multiple projects
•Deep knowledge of the clinical trial approval process on a global basis
•Extensive knowledge of FDA, ICH & GCP guidelines and regulations

Fluent English – written and spoken - is essential.

Significant global development experience, an MD qualification and experience in the Ophthalmology field - For more information, please email your CV to spencer@onlymedics.com

Key words: Ophthalmology, Ophthalmics, Ophthalmic, Development, Clinical, Benelux, Medical Doctor.

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