Position: Director, Clinical Affairs

1 settimana fa

Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pieno

Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access.

Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals.

Since 2008, Meditrial delivers unparalleled outcomes for innovators.

Our successful track record supporting the lifescience industry manufacturers in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden.

Through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration changing the paradigm of care towards understanding and value.

We have the ability to transcend the current landscape with "smart" technology enabled data collection tools and insights.

Meditrial offers highest level expertise across multiple therapeutic areas.

We are passionate about our mission to support the innovation and development of better therapies in compliance with solid ethical standards.

Our commitment has resulted in excellent results for business growth by creating stability and opportunities for employees and collaborators.

Position:

Director, Clinical Affairs:

Industry:

Lifescience Industry:
Pharma, Medtech, Digital Health

Employment Type:
Full-time

Job Functions:
Clinical Affairs

Location:
Meditrial, Via Po 9 Rome, Italy

Workplace:
Office-based / availability to travel


Meditrial is looking for a highly motivated, self-directed individual who will thrive in a fast-moving environment and possess strong interpersonal skills.

The role is responsible for leading and managing the strategy, planning, and execution of clinical research and investigational affairs while assuring full compliance with applicable GCP regulations as well as relevant worldwide standards and regulations.

Provides global leadership for Clinical Research Activities.

Capable of interfacing with data management, biostatistics, regulatory agents, clinical research associates, study coordinators, field clinical specialists, business stakeholders, medical/safety monitors, and functional management.

This role requires strong technical and client management skills, the ability to work with cross-functional teams: Sales, R&D, Management, Regulatory Affairs, and Marketing.

The position is meant to work in Meditrial's Rome Office, acting as strategic mentor to local team, fostering talents and effectively delegating.


Responsibilities:

  • Develop global clinical affairs strategies, in collaboration with regulatory affairs, marketing, research & development, reimbursement, and outcomes planning, and obtain fasttrack approvals
  • Develop and execute Clinical Strategies to generate data for both marketing and regulatory purposes
  • Engage and manage KOL / physicianclinicians and lead the management of all Clinical Affairs and required support
  • Support regulatory/clinical strategies as clinical affairs leader
  • Prepare clinical affairs budgets
  • Develop and manage the

Clinical Affairs Team:
assign, direct, and evaluate their work, and oversee the development and maintenance of staff competence

  • Develop clinical study strategy and protocols for investigational devices and/or for new products (Medical Device/Drug) being introduced to the marketplace
  • Oversee the management, planning, and execution of respective clinical studies
  • Provide oversight of individual clinical trials
  • Serve as an interface to site coordinators, investigators and other field personnel regarding study devices and clinical protocols.
  • Develop training and other clinical study support materials for investigational or study devices and procedures
  • Interface with relevant internal and external stakeholders to ensure that clinical studies meet targeted enrollment and approval timelines
  • Oversee the execution of clinical studies in compliance with FDA, local CAs, IRB and ECs and other applicable regulations and requirements, ICH guidelines, ISO standards, GCP requirements and in alignment with internal procedures, business goals and objectives
  • Support and contribute to staffing plans according to needs
Skillset & Qualifications

  • 812 years' experience in clinical/scientific medical devices/pharmaceutical clinical trials and research.
  • 5 years' experience managing projects and working with clinical professionals and crossfunctional product development teams
  • Well versed in EU and FDA regulations and standards and GCP, ICH guidelines
  • Familiar with the laws, regulations, standards, and guidance governing the conduct of clinical studies
  • Excellent leadership, management, collaboration, and effective decisionmaking skills
  • Education: Bachelor's degree in Lifescience, Master in a hea

  • Medical & Regulatory Affairs Director Italy

    1 settimana fa

    Roma, Lazio, Italia Ipsen A tempo pieno

    Title:Medical & Regulatory Affairs Director ItalyCompany:Ipsen SpAJob Description:Job title: Medical & Regulatory Affairs DirectorDepartment: Medical & Regulatory Affairs DirectorLine Manager: Country General ManagerPurpose of the positionTo ensure, within Corporate and company strategic and management policies, medical and scientific support of recognized...

  • Cardiac Cath Lab Rn Assistant Director

    1 settimana fa

    Roma, Lazio, Italia Clinical Management Consultants A tempo pieno

    An innovative facility in the heart of NYC seeks their next Cardiac Cath Lab RN Assistant Director. This is a great opportunity to join a unit that is one of the nation's heart and vascular patient care leaders.This key RN leader will join a 700+ bed hospital committed to continuous innovation and clinical excellence. This Level 1 Trauma Center has been...

  • Cluster Medical Affairs Operations Coordinator

    1 settimana fa

    Roma, Lazio, Italia Blueprint Medicines A tempo pieno

    Title: Cluster Medical Affairs Operations Coordinator, Contractor (Italy, Spain)Location: Italy/SpainRequisition Number: 444How will your role help us transform hope into reality?The Medical Affairs Operations contractor role is responsible for providing critical project management support in country medical affairs projects over the entire life of the...

  • Senior Director/Executive Director, Global Regulatory Affairs-EMEA

    7 giorni fa

    Roma, Lazio, Italia Eli Lilly and Company A tempo pieno

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate Director, Project Management

    7 giorni fa

    Roma, Lazio, Italia Worldwide Clinical Trials A tempo pieno

    Requisition Number6259Employment Type:RegularSUMMARY: The Associate Director, Project Management (ADPM) will provide support and oversight of large, multi-national projects, responsible for directing large national or global projects or a program of projects, and/or complex projects in terms of customer/deliverables, providing functional leadership to PMs....

  • Director, Programs

    7 giorni fa

    Roma, Lazio, Italia Breaking Ground A tempo pieno

    Breaking Ground Director, Programs New York , New York Apply Now Seafarers, 123 East 15th Street, New York, New York, United States of AmericaFriday, April 12, 2024ABOUT US: - We believe that everyone deserves a homeBreaking Ground operates nearly 4,000 units of housing across New York City, along with housing in upstate New York and Connecticut. Supportive...

  • Clinical Medical Manager Lead

    7 giorni fa

    Roma, Lazio, Italia Novo Nordisk A tempo pieno

    Clinical Medical Manager Lead - Serious Chronic DiseasesCategory:Clinical DevelopmentLocation:Roma, Lazio, IT- Are you interested to be part of global company with great reputation worldwide, working every day to improve the life of many people living with serious chronic diseases? Are you a people leader, motivated to drive your team through significant...

  • Sr. Clinical Research Associate

    1 settimana fa

    Roma, Lazio, Italia Cmed A tempo pieno

    The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Czech Republic, Switzerland, Denmark, Romania, and India.The CRO occupies a unique position in the clinical...

  • Head of Corporate Affairs

    1 settimana fa

    Roma, Lazio, Italia Confidenziale A tempo pieno

    Head of Corporate Affairs & Compliance Rome Legal Affairs Manager Corporate Law and Compliance Rome Role We have been instructed by an Italian listed company to source a Head of Corporate Affairs & Compliance on a permanent basis. The position is based in Rome and reports to the General Counsel.RequirementYou will be an Italian qualified lawyer with around...

  • Humanitarian Affairs Officer/Internal Displacement Adviser, P4

    1 settimana fa

    Roma, Lazio, Italia United Nations A tempo pieno

    Job Opening Job Opening ID:Job Network : Political, Peace and Humanitarian Job Family : Humanitarian Affairs Category and Level : Professional and Higher Categories , P-4 Department/Office : Office for the Coordination of Humanitarian Affairs This position is located in the Internal Displacement Unit, Office of the Under-Secretary General for Humanitarian...

  • Oncology Medical Affairs Head

    1 settimana fa

    Roma, Lazio, Italia Takeda Pharmaceutical A tempo pieno

    _ ACCOUNTABILITIES_Leadership: Develops and defines, in alignment with the Global Medical Affairs Oncology team, the Italian medical/clinical strategy for the Oncology Division. Oversees the implementation of these strategies and annual project plans. Identifies and provides mitigation strategies for issues identified in therapeutic areas, responding...

  • Clinical Research Manager

    7 giorni fa

    Roma, Lazio, Italia Novo Nordisk A tempo pieno

    The Italian affiliate of Novo Nordisk, based in Rome, is hiring a Clinical Research Manager (CRA Team Manager).Do you want to join one of the leading companies of the pharma sector? Do you want to build your career and contribute to the growth and development of the company? We're on the lookout for a knowledgeable, proactive, dedicated people manager to...

  • Senior Political Affairs Officer, P-5

    7 giorni fa

    Roma, Lazio, Italia United Nations A tempo pieno

    Job Network : Political, Peace and Humanitarian Job Family : Political Affairs Category and Level : Professional and Higher Categories , P-5 Department/Office : Department of Political and Peacebuilding Affairs-Department of Peace Operations-Shared Structure The position is located in the Departments of Political and Peacebuilding Affairs (DPPA) and Peace...

  • Senior Director

    7 giorni fa

    Roma, Lazio, Italia The Jewish Board of Children and Family Services A tempo pieno

    The Jewish Board of Children and Family Services Senior Director New York , New York Apply Now Make a bigger differenceWORKING WITH USAt The Jewish Board, we don't just make a difference - we make a bigger difference as we serve 45,000 New Yorkers every year. Join our dedicated team that's been helping communities across New York City for almost 150 years...

  • Clinical Research Associate

    3 settimane fa

    Roma, Lazio, Italia MSD A tempo pieno

    The Clinical Research Associate RoleThe role of Clinical Research Associate involves overseeing the performance and compliance of assigned protocols and sites in a country. Under the guidance of the CRA manager, the individual ensures study conduct compliance with ICH/GCP, country regulations, Company policies, quality standards, and adverse event reporting...

  • Clinical Research Associate

    1 mese fa

    Roma, Lazio, Italia MSD A tempo pieno

    The Clinical Research Associate RoleThe role of Clinical Research Associate involves overseeing the performance and compliance of assigned protocols and sites in a country. Under the guidance of the CRA manager, the individual ensures study conduct compliance with ICH/GCP, country regulations, Company policies, quality standards, and adverse event reporting...

  • Clinical Research Associate

    1 settimana fa

    Roma, Lazio, Italia MSD A tempo pieno

    The Clinical Research Associate RoleThe role of Clinical Research Associate involves overseeing the performance and compliance of assigned protocols and sites in a country. Under the guidance of the CRA manager, the individual ensures study conduct compliance with ICH/GCP, country regulations, Company policies, quality standards, and adverse event reporting...

  • Clinical Medical Manager

    1 settimana fa

    Roma, Lazio, Italia Novo Nordisk A tempo pieno

    Clinical Medical Manager - Cardiovascular (Multiple Locations)Category:Clinical DevelopmentLocation:Roma, Lazio, IT- Are you ready to be the link between clinical and medical realms?If so, join our newly formed team of knowledgeable and talented experts as a Clinical Medical Manager at Novo Nordisk Italy and bring your medical and scientific expertise to...

  • Clinical Start-up Specialist

    1 settimana fa

    Roma, Lazio, Italia Novo Nordisk A tempo pieno

    Are you an experienced clinical research professional interested in the start-up and regulatory aspects? Do you need to have things in order, and attention to detail is one of your qualities? If you are ready to make a difference in our clinical department, you might be our new Clinical Start-Up Specialist. Apply today and drive the change with us at Novo...

  • Medical Affairs Scientist Oncology

    1 settimana fa

    Roma, Lazio, Italia Pfizer A tempo pieno

    Pfizer is looking for a Passionate, Talented, Innovative Medical Affairs Scientist (MAS) in the Oncology Medical Affairs Department to cover maternity leave.The hiring of the MAS Oncology, Hematology aligns with Pfizer's goal of fostering growth opportunities and leading scientific innovation in the Oncology Therapeutic Areas.The MAS Oncology, Hematology...