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Full-time
postgraduate degree
Competitive Base Salary, Performance Related Incentives, Medical Coverage, Dental Coverage, Vision Coverage, Retirement And Pension Plans
Posted 15d ago
~40 hrs/week
Remote in Reading, England, United Kingdom
Responsibilities
The Medical Director oversees the execution of clinical trials in Neuroimmunology, specifically focusing on Lupus SLE, for a top-5 pharma client. Responsibilities include developing clinical development plans, overseeing medical writing for protocols, and managing clinical teams and scientific risks.
Requirements
A mandatory Medical Degree and substantial professional experience in immunology clinical trials, including at least 3 years as a medical responsible, are required. Candidates must be proficient in GCP, ICH, FDA, and EMA regulations and be able to communicate effectively in English.
Full job description
Medical Director Neuroimmunology
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Medical Director in immunology (Lupus SLE) serves as a medical responsible on clinical trial(s), overseeing execution of clinical trial activities in assigned projects.
This role is client dedicated to top-5 pharma company
Ability to engage and work with Key Opinion Leaders or Scientific Advisors in the relevant therapeutic area to help develop scientific rationale for clinical trials
Develop and/or oversee the preparation of clinical development plans, study concept sheets, study protocols or regulatory documentation in collaboration with clinical and project team members for assigned indication(s)/products or with external partners for collaborative studies
Actively contribute to or oversee medical writing of medical sections of study protocols, investigator brochure and other regulatory documents
Manage the clinical team supporting the clinical trial
Manage, mentor and develop assigned staff, as appropriate
Oversee all aspects related to the scientific and medical risk in collaboration with the safety representative and other relevant stakeholders
Support the review, analysis and interpretation of study data
Support communication of study results as assigned
EDUCATION & LANGUAGES
Medical Degree (mandatory)
Immunology experience (Lupus SLE)
Able to communicate effectively in English
Experience leading protocol development
PROFESSIONAL SKILLS & EXPERIENCE
Requires substantial professional experience in related TA/indication including clinical trials
Professional experience in the execution of clinical trials as medical responsible (3+ years)
Previous experience in medical monitoring, medical data review, eligibility review during recruitment, presentations at investigator meetings and trainings, protocol writing, regulatory responses
Experience in design, set up, conduct and evaluation of clinical trials
Experience working in a cross-functional multi-site team environment
Working knowledge of GCP, ICH, US FDA and EMA regulations
PERSONAL SKILLS & COMPETENCIES
Ability to work in an intense, fast paced, global work environment
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
Medical DeviceTherapeuticsGovernment and Public Health SolutionsClinical Research ServicesCommercialisation and OutcomesOncologyValue Based HealthcareClinical TrialsPatient RecruitmentInnovation
How many Science & Research jobs are open in Frankfurt, Germany right now?
There are currently 234 open science & research positions in Frankfurt, Germany listed on Clera. New openings are added daily as companies post roles.
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