Medical Director (Dermatology)

TN Italy; Roma; In loco; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Senior Medical Director to join their dynamic Dermatology team. This pivotal role involves guiding clinical trials, ensuring safety oversight, and providing expert regulatory support. You will work independently, leveraging your deep medical expertise to address complex medical and regulatory issues. The company values collaboration and innovation, offering a competitive compensation package and opportunities for personal and professional growth. If you are passionate about making a difference in patients' lives and thrive in a fast-paced environment, this role is perfect for you.

Servizi

Competitive compensation package

Comprehensive benefits

Personal and professional growth opportunities

Collaborative work environment

Competenze

• Medical Doctor with 5+ years in clinical practice and clinical trial expertise.
• Strong understanding of GCP, ICH guidelines, and pharmacovigilance legislation.

Mansioni

• Provide medical input on study design and trial protocols.
• Conduct senior-level medical reviews and mentor junior medical staff.

Conoscenze

Medical Doctor (MD)

Clinical Trial Expertise

Regulatory Knowledge

Adaptability

Communication Skills

Professional Credibility

Formazione

Medical Degree

Descrizione del lavoro

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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.

Join Our Team as a Medical Director.

About this role

As part of our Dermatologyteam 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: (Max 5-6)

• Medical Qualifications: Medical Doctor (MD) with specialist medical training 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 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.