Senior/Medical Director (Ophthalmology) 0.5 FTE

TFS HealthScience Location Not Available

Stellenbeschreibung:

Overview

Senior/Medical Director (Ophthalmology), 0.5 FTE. TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their clinical development journey.

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. 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 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 will 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 Lund, Sweden. 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 guide decision-making at all levels of the organization. They help us attract and retain valuable talent who share these values, fostering high employee engagement and collaboration. Together we make a difference.