Medical Director

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

We are serching for a Medical Doctor located in Belgium, The Netherlands, Germany, UK, France, Spain or Poland

Overall Focus:

• Provides clear medical leadership in the study team
• Works closely with the other members of the cross functional team to provide reliable, high quality study data on time and within budget

Tasks:

• Create clinical trial protocols while implementing the latest scientific information
• Contribute to site selection
• Contribute to review and approval of:
  • Study protocols and amendments
  • Clinical Study Reports (CSRs)
  • Informed Consent Forms (ICFs)
  • Case Report Forms (CRFs)
  • Protocol deviation decisions
  • Other clinical documents as required for the conduct of clinical trials
• Realtime medical monitoring of clinical studies*: Ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early. Pro-active escalation and correction of issues in consultation with the Global Medical Indication Lead
  • * Medical monitoring not needed for the requested role as the medical monitoring is outsourced already to ICON. This position will need to “support” medical monitoring questions and/or provide medical monitoring oversight if needed.
• Interpret clinical trial data for regulatory documents (e.g., Clinical Study Report (CSR), Investigational New Drug (IND), Annual Reports, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), etc.), manuscripts, and other publications as required, in consultation with the Indication Lead
• Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical  training of site staff at Investigator meetings; CRA training in new indications
• Ensure study compliance for all medical aspects by understanding and applying relevant SOPs and GCP
• Closely collaborate with the cross functional study team members so all medical risks, issues, and results are clear for all involved parties
• If more than one physician is working on the protocol, a primus inter pares will be appointed and they will ensure answers to questions from sites/IRBs, RAs, eligibility and protocol deviation decisions will be harmonized across medics

Desired Skills and Experience:

• Medical Doctor with relevant specialty education preferred (dermatology, pediatric)
• Iindustry experience 3 to 5 years
• Excellent English, both written and spoken, is a must
• Ability to travel to Brussels once a month for 3 to 4 days, 
• Proven interpersonal skills that support leading a study team while recognizing individual expert competencies
• Ability to identify and prioritize medical advice and evaluations regarding which issues need immediate escalation
• Pro-active problem solver with negotiation skills
• Remaining sensitive to different cultural needs in a global organisation
• Strong communication skills to ensure close collaboration with a cross functional team so study plans and status are transparent, and risks, issues, and results are clear to all involved parties
• A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.