pJob Overview /ppThe medical department consists of a Chief Medical Officer, Medical Directors, Sr Medical Directors, Medical Writers, and Safety Associates.The Medical Director provides medical and scientific support to clinical research programs, study teams and investigators.The Medical Director also provides review, advice, and leadership for potentially or awarded clinical research programs. /ppThe Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams.The primary role of Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the Medical Director are outlined below: /ppEssential Functions /ppFunctions as project team member: /pulliProvides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation, and reporting. /liliEnsures medical activities run according to GCP and operate with highest efficiency. /liliEstablishes and maintains a network of medical/scientific consultants, etc. /liliSupervises and manages Medical Director activities. /li /ulpClinical Activities: /pulliInteracts with clients regarding drug development programs, study design and protocol. /liliReviews and provides input for protocol development.Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. /liliInteracts in team approach to develop statistical and data management sections of the protocol. /liliReviews the final protocol for clinical, safety and efficacy variables. /liliProvides project team training on protocol and/or therapeutic areas. /liliAssists team with developing criteria for investigator site selection and networking for potential investigators for study participation.Aids in review and final selection. /liliParticipates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators, and site staff and/or participation in teleconference and WebEx presentations. /liliPresents protocol and/or safety reporting information at investigator meetings. /liliDevelops project medical monitoring plans as requested.



/liliProvides on call coverage for protocol queries and site support. /liliProvides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues. /li /ulpSafety Monitoring and SAE Reporting Activities: /pulliVerifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study. /liliProvides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed. /liliReviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data. /liliIn consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind). /liliInteract with appropriate FDA officials concerning safety and other study related issues, as requested. /li /ulpData Activities: /pulliProvides medical review of eCRFs for clinical accuracy. /liliProvides medical review of data analysis plan. /liliReviews safety fields at case freeze for reconciliation (if needed). /liliWorks with data group to reconcile SAE events as needed. /liliReviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends. /liliReviews data tables, listings, and figures. /liliReviews and/or writes portions of final clinical study report. /li /ulpDSMB/Adjudication Committee Activities: /pulliMay assist sponsor in choosing committee members. /liliMay serve as a non-voting member to convene and organize proceedings. /liliMay develop operating guidelines in conjunction with committee members and submits these to sponsor for review. /liliMay determine data flow with sponsor to ensure reporting accuracy. /liliCan ensure DSMB feedback is given to sites for IRBs. /liliAll DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical monitor. /li /ulpBusiness Development Activities: /pulliWork with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development. /liliSupports business development activities with proposal development and sales presentations. /liliParticipates in feasibility discussions relating to specific project proposals. /li /ulpSpecial Projects:



/pulliObtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc. /liliAssists with drafting of standard operating procedures and working practices regarding all Medical Director activities. /liliParticipate in a variety of team quality improvement efforts as necessary. /liliPerform other related duties as assigned or requested by the Chief Medical Officer. /li /ulpQualifications /pulliMedical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education. /lili10 years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development. /lili3-5 years of biopharmaceutical (industry) experience is preferred which can be part of the 10-year experience. /liliAbility to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus. /liliOutstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment. /liliAbility to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities. /liliExcellent oral and written communications skills as well as interpersonal skills are essential. /li /ulpOncology / Hematology /pulliBoard Certified / Board Eligible: Oncology (Required) /liliPreferably : Urologist / Surgical Oncology /li /ulpIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at /ppIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. /ppThe potential base pay range for this role, when annualized, is 98,600.00 - 167,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. /ph3Summary /h3ulliLocation: Milan, Italy; Rome, Italy /liliType: Tempo pieno /li /ul #J-18808-Ljbffr

📌 Medical Director - Oncology, Sponsor Dedicated (Home-Based) (Roma)
🏢 Bridgestone
📍 Roma