Medical Director Rheumatology/Neurology/Dermatology

Job Title: Medical Director (Neurology/ Rheumatology/ Dermatology)

Please note you must be able to work in the EU without restriction or sponsorship to be eligible for this role. If you are interested in finding out more about this role or others, please contact Manpreet Bhullar at mbhullar@i-pharmconsulting.com or call UK: +44 (0)20 7551 0802 / EU: +31 20 809 0665.

i-pharm consulting is collaborating with a global contract research organisation concerned with providing comprehensive, integrated drug development, laboratory and lifecycle management services. We are seeking Medical Director to join them on their mission to enable their customers to make the world healthier, cleaner and safer. Due to their continued growth, they are now looking to appoint a Medical Director - Clinical Trial Physician, specialising either in Neurology, Rheumatology or Dermatology, to join their team of Medical Directors in EMEA. This role can be worked remotely. The Clinical Trial Physician will be responsible for providing medical support and medical advice.

Essential Functions:

• Provide medical leadership to 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 trials
• 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 for medical risks, issues, and results to be clear to all involved parties

Education & Qualifications

• MD and equivalent degree and strong medical knowledge, proven clinical experience managing patients in hospital practice
• Must be board certified
• Active medical licensure (preferably in country of residence)
• Several years of relevant experience such as pharmaceutical industry or CRO, in clinical development or pharmacovigilance or significant clinical trial experience as a principal investigator, and experience treating patients in a clinical setting.

Knowledge, Skills and Abilities:

• Ability to work independently, analyse and work with diligence, process and prioritize sensitive complex information, and problem solve
• Ability to exercise creativity and judgment
• Expert knowledge regulations governing adverse event reporting
• Understanding guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies
• Assertive in sponsor discussions
• Understanding biostatistics, data management, and clinical operations' procedures
• Ability to mentor effectively on global medical processes in both one-on-one and in group settings.
• Overall knowledge of the drug development process