Senior / Medical Director (Ophthalmology)

TFS HealthScience; Hamburg; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A leading global Contract Research Organization is seeking a medical professional for their Ophthalmology team in Hamburg, Germany. The ideal candidate will provide expert guidance on study designs and protocols, review safety data from trials, and engage in regulatory processes. Candidates should have an MD with training in Ophthalmology and over 5 years of clinical experience, along with strong communication skills. Join a collaborative team dedicated to improving patient outcomes and enjoy competitive compensation and benefits.

Leistungen

Competitive compensation package

Comprehensive benefits

Opportunity for professional growth

Qualifikationen

• 5+ years experience in clinical practice and trial protocols.
• Experience on safety data review boards in clinical research.
• Strong knowledge of GCP, ICH guidelines and pharmacovigilance.

Aufgaben

• Provide advanced medical input on study design and protocols.
• Review safety data from a medical perspective.
• Conduct senior-level medical reviews of individual cases.
• Serve as a medical monitor in clinical trials.
• Offer insights into regulatory submissions and documentation.

Kenntnisse

Expert medical input on study design

Safety data review

Regulatory knowledge

Excellent communication skills

Medical monitoring

Ausbildung

Medical Doctor (MD) with specialist training in Ophthalmology

Jobbeschreibung

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.

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 Ophthalmology and 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.