ICON Strategic Solutions Global Clinical Trial Physician (Rheumatology - East Coast) in Topeka, Kansas
The Medical Director will provide clear medical leadership in the study team, working in close collaboration with the other members of this cross functional team, in order to provide reliable, high quality study data within time and budget.
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 organizations. With our patients at the center 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.
Provide medical leadershipto the study teams , including creating 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 and other clinical documents as required for the conduct of clinical trial
Real time 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
Interpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, 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 all relevant SOPs and GCP
Closely collaborate with the cross functional study team members in order for medical risks, issues and results to be clear to all involved parties
In case more than 1 physician is working on the protocol, a primus inter pares will be appointed and he/she will ensure that answers to questions from sites /IRBs RAs, eligibility and protocol deviation decisions will be harmonized across medics
Medical Doctor; relevant specialty education preferred ( e.g. neurology, hematology, dermatology , immunology, rheumatology, internal medicine, pediatric)
3 years CRO or Pharmaceutical experience required
Excellent English, both written and spoken is a must
Ability to travel (3-4 days per month)
Proven interpersonal skills enabling to lead a study team, while recognizing individual expert competencies, providing medical advice and evaluations exercising judgement in which issues need to be escalated immediately
Proactive problem solver with negotiation skills remaining sensitive to the different cultural needs in a global organization
Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent and that 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.