-
Medical Director- Oncology/Hematology
hace 3 semanas
IQVIA LLC Comunidad de Madrid, EspañaMedical Director- Oncology/Hematology (Home-Based) page is loaded · Medical Director- Oncology/Hematology (Home-Based) · Apply locations Prague, Czech Republic Lisbon, Portugal Budapest, Hungary Warsaw, Poland Athens, Greece time type Full time posted on Posted 30+ Days Ago job ...
-
Medical Director- Oncology/Hematology
hace 1 semana
Iqvia Llc Madrid, EspañaMedical Director- Oncology/Hematology (Home-Based) page is loadedMedical Director- Oncology/Hematology (Home-Based)ApplylocationsPrague, Czech RepublicLisbon, PortugalBudapest, HungaryWarsaw, PolandAthens, Greecetime typeFull timeposted onPosted 30+ Days Agojob requisition idR139 ...
-
Medical Director- Oncology/Hematology
hace 1 semana
Iqvia Llc Madrid, EspañaMedical Director- Oncology/Hematology (Home-Based) page is loaded Medical Director- Oncology/Hematology (Home-Based) Apply locations Prague, Czech Republic Lisbon, Portugal Budapest, Hungary Warsaw, Poland Athens, Greece time type Full time posted on Posted 30+ Days Ago job requi ...
-
Oncology Clinical Quality Associate Director
hace 1 semana
AstraZeneca Madrid, EspañaAt AstraZeneca we believe in the potential of our people and you'll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. · The Oncology Clinical Quality Asso ...
-
AstraZeneca Madrid, España**Global Director Scientific Partnerships, GMA, Oncology Business Unit** · **Field based Europe role (based from an EU5 market or Switzerland)** · Join our globally-renowned Oncology area, which is leading the rapid business growth of our enterprise and ever-evolving industry. It ...
-
Hematology/Oncology Account Manager
hace 3 semanas
Massive Bio EspañaAccount Manager, Spain - Hematology/Oncology · Massive Bio is a rapidly growing health-tech startup founded in 2015 to provide every cancer patient with access to clinical trials regardless of location or financial situation. Our proprietary patient recruitment and enrollment en ...
-
Oncology Local Study Associate Director
hace 3 semanas
AstraZeneca Madrid, EspañaAt AstraZeneca, we're not afraid to do things differently. We're building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams.toget ...
-
EMEA Medical Affairs Director Hematology
hace 2 semanas
Johnson & Johnson Comunidad de Madrid, EspañaJob Description - EMEA Medical Affairs Director Hematology W) · EMEA Medical Affairs Director Hematology W · Description · Johnson & Johnson is currently seeking an EMEA Medical Affairs Director Hematology to join our EMEA Strategy & Operations organisation. · At Johnson & Jo ...
-
EMEA Medical Affairs Director Hematology
hace 2 semanas
J&J Family of Companies Community of Madrid, España Paid WorkEMEA Medical Affairs Director Hematology W · Description · Johnson & Johnson is currently seeking an EMEA Medical Affairs Director Hematology to join our EMEA Strategy & Operations organisation. · At Johnson & Johnson, we believe health is everything. Our strength in healthcare i ...
-
Sr. Commercial Strategy Manager Hematology
hace 1 semana
Pfizer Madrid, EspañaSr. Commercial Strategy Manager Hematology (acute leukemias) & Biosimilars · ROLE SUMMARY: · Pfizer's Hematology & Biosimilars portfolio is a growing franchise within the Oncology Business Unit, currently focused on CML, AML and ALL and expanding into MM. BOSULIF, indicated in Ch ...
-
Business Intelligence
hace 3 semanas
Bristol Myers Squibb Madrid, EspañaAt Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues con ...
-
Senior Clinical Project Manager, Oncology, Emea
hace 2 semanas
Fortrea - Organic Madrid, EspañaOncology patients are waiting for personalized cancer care options. What if your Senior Clinical Project Manager expertise was the only thing we need to make them possible? · At Fortrea we are committed to developing a comprehensive way to treat cancer and improve lives. To make ...
-
Senior/principal Clincial Team Manager
hace 2 semanas
Thermo Fisher Scientific Madrid, EspañaAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed ...
-
Value Added Services Manager
hace 2 semanas
Bristol Myers Squibb Madrid, España**Working with Us** · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production ...
-
Oncology Business Unit Support
hace 2 semanas
ARIAD Madrid, EspañaAt Takeda Oncology, we aspire to cure cancer, with inspiration from patients and innovation from everywhere. We value employees with diverse perspectives and backgrounds. As a member of our team, you would bring your unique perspective to help us achieve our aspiration and help u ...
-
Oncology Diagnostic Lead
hace 3 semanas
AstraZeneca Madrid, EspañaAt AstraZeneca, we're not afraid to do things differently. We're building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams.toget ...
-
Clinical Trial Manager
hace 2 semanas
Bristol Myers Squibb Madrid, EspañaAt Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues con ...
-
PMO Oncology Medical Department
hace 2 semanas
Daiichi-Sankyo Europe Madrid, España**Passion for Innovation. Compassion for Patients.**: · Daiichi Sankyo y sus empleados en más de 20 países se dedican a la creación y suministro de productos farmacéuticos innovadores. En Europa, nos centramos en dos áreas: Cardiovascular, con una sólida cartera de medicamentos, ...
-
Key Account
hace 2 semanas
Blueprint Medicines Madrid, España**Title**:Key Account & Access Manager · **Location(s)**:Barcelona, Madrid · **Level of position**:Senior Manager*** · **Position type**:Field-based · **Reporting Line**:The position reports to the Commercial Lead Spain · **How will your role help us transform hope into reality?* ...
-
Clinical Trial Monitor
hace 2 semanas
Bristol Myers Squibb Madrid, EspañaAt Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues con ...
Medical Director- Oncology/Hematology - Madrid, España - IQVIA
Descripción
Job Overview
The medical department consists of a Chief Medical Officer, 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.
The 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:
Essential Functions
• Functions as project team member
Provides 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
Ensures medical activities run according to GCP and operate with highest efficiency
Establishes and maintains a network of medical/scientific consultants, etc.
Supervises and manages Medical Director activities
• Clinical Activities:
Interacts with clients regarding drug development programs, study design and protocol
Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables.
Provides project team training on protocol and/or therapeutic areas
Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection.
Participates 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
Presents protocol and/or safety reporting information at investigator meetings
Develops project medical monitoring plans as requested
Provides on call coverage for protocol queries and site support. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.
• Safety Monitoring and SAE Reporting Activities:
Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study
Provides 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
Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data
In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)
Interact with appropriate FDA officials concerning safety and other study related issues, as requested
• Data Activities:
Provides medical review of eCRFs for clinical accuracy
Provides medical review of data analysis plan
Reviews safety fields at case freeze for reconciliation (if needed)
Works with data group to reconcile SAE events as needed
Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends
Reviews data tables, listings, and figures
Reviews and/or writes portions of final clinical study report
• DSMB/Adjudication Committee Activities:
May assist sponsor in choosing committee members
May serve as a non-voting member to convene and organize proceedings
May develop operating guidelines in conjunction with committee members and submits these to sponsor for review
May determine data flow with sponsor to ensure reporting accuracy
Can ensure DSMB feedback is given to sites for IRBs
All DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical monitor
•Business Development Activities:
Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development
Supports business development activities with proposal development and sales presentations
Participates in feasibility discussions relating to specific project proposals
• Special Projects:
Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities
Participate in a variety of team quality improvement efforts as necessary
Perform other related duties as assigned or requested by the Chief Medical Officer
Qualifications
Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education
10 years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development
3-5 years of biopharmaceutical (industry) experience is preferred which can be part of the 10-year experience
Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus
Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment
Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities
Excellent oral and written communications skills as well as interpersonal skills are essential
Oncology; Hematology;
Current or prior license to practice medicine; board certification/eligibility ideal (Preference)
Board Certified / Board Eligible: Oncology/ Hematology (Required)
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at