Clinical Development Physician Ophthalmology Medical Director

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose and Scope:

The primary objective for the Development Physician is to provide input into the design and conduct of clinical trials, review and/or generate key study documents (such as medical monitoring and safety management plans, treatment manuals, etc.), assess and interpret safety data, and contribute to investigator, site staff and clinical study team training.

Responsibilities and Accountabilities:

• In collaboration with the Medical Lead, responsible for designing and making recommendations in the clinical development plan that are aligned with the asset development strategy, after soliciting appropriate input and review from Medical and Clinical Operations colleagues as well as other contributing line functions (Regulatory Affairs, Statistics, Clinical Operations, Commercial).
• Be available to advise on assigned clinical trial(s) related medical questions or problems during the trial, including 24/7 emergency coverage for safety-related matters.
• Reviews and analyzes the eligibility of participants per inclusion/exclusion requirements of a clinical trial.
• Reviews all adverse events to look for trends or risks, reviews all serious adverse events (SAEs), including review of the narrative, investigators' assessment on causality, and applicable regulatory reporting, with close collaboration with the study's Global Safety Officer.
• Provides review of study protocols and ongoing medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed. Ensures activities related to Serious Adverse Events (SAEs) are conducted in accordance with applicable SOPs and regulations. Includes writing and/or reviewing Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
• Consults with internal and external stakeholders in the development of clinical trial design and conduct, including drafting of protocols and amendments.
• Develops and/or reviews operational, medical monitoring, and safety plans for studies.
• Leads and/or participates in scientific and medical training of other team members and external clients, investigators, and other site staff as it pertains to assigned studies.
• Generates safety-related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
• In collaboration with the Medical Lead:
• Health Authorities communication: the Development Physician is responsible for clinical written feedback/response to deficiency letter, pre-IND/NDA communication meeting, or panel review meeting
• Investigators/KOL engagement: Development Physician is responsible for KOL/investigators scientific engagement.