Senior/Medical Director (Ophthalmology) 0.5 FTE

Das ist der Job

Overview Senior/Medical Director (Ophthalmology), 0.5 FTE.

Darum lohnt es sich

Join our team as a Senior/Medical Director (Ophthalmology). The Senior/Medical Director is a key member of the Project Delivery team, working independently to manage safety and medical matters in line with company policies, standard operating procedures (SOPs), and regulatory requirements.

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their clinical development journey.

With deep medical expertise, this role serves as the primary authority on medical issues—providing clear, informed guidance and answering complex questions related to medical, legal, and regulatory concerns.

Responsibilities Expert Guidance: Provide advanced medical input on study design, measurement strategies, and trial protocols, including safety sections and investigator brochures. Comprehensive Safety Oversight: Review safety data such as adverse events, labs, vital signs, ECGs, and clinical trial reports from a medical perspective.

Regulatory & Risk Support: Conduct senior-level medical reviews of individual cases, cumulative listings, PSURs, PBRERs, DSURs, and Risk Management Plans. Medical Monitoring & Signal Detection: Serve as a medical monitor in trials, perform literature reviews, and contribute to signal detection and interpretation.

Regulatory Document Contributions: Offer expert medical insight into regulatory submissions and sa