Medical Director
- Employer
- ICON Strategic Solutions
- Location
- Belgium, Homeworking
- Salary
- Competitive
- Start date
- 22 Mar 2023
- Closing date
- 20 Apr 2023
View more
- Discipline
- Medical Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
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.
Company
As the largest global provider of Functional Service Provision (FSP) with over 90 partnerships and 14,000+ employees, we have deployed FSP solutions across all major functions, from clinical monitoring and project management through data management, statistical programming, and beyond.
ICON Strategic Solutions teams are embedded in our clients' businesses, working as a dedicated resource within some of the world’s leading Pharmaceutical & Biotech companies. You will play a key role in helping to deliver cutting-edge research, working on novel therapies that deliver real impact.
Why choose a career with ICON Strategic Solutions?
Meaningful Work: You’ll contribute to cutting-edge projects that have a real impact on global healthcare. Your work will play a pivotal role in shaping the future of medicine and improving patient lives.
Collaborative Environment: We foster a collaborative and inclusive work culture that thrives on teamwork, diversity, and knowledge sharing. You'll have the opportunity to collaborate with industry-leading experts, learning from their experiences and growing both professionally and personally.
Innovative Technologies: At ICON Strategic Solutions, we embrace the latest technologies and tools to enhance our capabilities. You'll have access to state-of-the-art software and resources, empowering you to deliver high-quality results efficiently.
Career Growth: We value our employees and invest in their professional development. You'll have access to comprehensive training programs, mentorship opportunities, and a clear career progression path. We believe in recognizing and rewarding exceptional performance, providing ample scope for advancement within the organization.
Global Reach: Joining ICON Strategic Solutions means being part of a truly global company. With service capabilities in 92 countries, you'll have the chance to collaborate with colleagues from diverse backgrounds and gain exposure to projects with a global reach.
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