Senior / Medical Director (Ophthalmology)

TFS HealthScience; Roma; In loco; EUR 90.000 - 110.000; Tempo pieno

Descrizione del lavoro

A leading global Contract Research Organization is seeking a Senior Medical Director in Ophthalmology. You will provide advanced input on study design, conduct safety oversight, and engage with clients. The ideal candidate is a Medical Doctor (MD) with at least 5 years of experience and expertise in clinical trials. Competitive compensation and benefits are offered.

Servizi

Competitive compensation package

Comprehensive benefits

Opportunities for personal and professional growth

Competenze

• At least 5 years of experience in clinical practice.
• Experience on safety data review boards or equivalent in clinical research.
• Strong understanding of GCP, ICH guidelines, and pharmacovigilance legislation.

Mansioni

• Provide advanced medical input on study design and trial protocols.
• Review safety data from a medical perspective.
• Conduct senior-level medical reviews of individual cases and reports.

Conoscenze

Expertise in Ophthalmology

Strong communication skills

Regulatory knowledge

Adaptability

Clinical trial expertise

Formazione

Medical Doctor (MD)

Specialist training in Ophthalmology

Descrizione del lavoro

Join Our Team as a Senior / Medical Director (Ophthalmology).

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

About this role

As part of our Ophthalmology team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

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. 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.

Key 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 safety-related documentation.

Team & Client Engagement: Mentor junior medical staff, support SOP / tool development, and join Commercial Operations in client meetings and presentations.

Qualifications

• Medical Qualifications : Medical Doctor (MD) with specialist medical training in Ophthalmologyand at least 5 years’ experience in clinical practice.
• Clinical Trial Expertise : Experience serving on safety data review boards or equivalent roles in clinical research.
• Regulatory Knowledge : Strong understanding of GCP, ICH guidelines, pharmacovigilance legislation, and internal SOPs.
• Adaptability : Comfortable working in fast-paced environments with shifting priorities and deadlines.
• Communication Skills : Excellent verbal and written communication, able to convey complex ideas clearly to diverse audiences.
• Professional Credibility : Trusted medical professional with a strong foundation in both clinical and research settings.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.