Vai al contenuto principale

Clinical Research Physician - Asthma Purpose

The CRP contributes to the clinical development of the respiratory pipeline by authoring and validating scientific documents relevant to clinical studies (e.g.: study protocol, case report form, Investigator’s Brochure, clinical study report, publications, etc.), and representing the Company in front of advisory boards and institutional authorities. The CRP is a member of the Study Team using his/her clinical / therapeutic expertise to increase technical knowledge and competencies across functions.

Main Responsibilities

  • Acting as a member of the Clinical Study Team, deliver the results of the assigned Clinical Studies and the related Key Clinical Documents, in accordance with the Clinical Development Plan and the related agreed timelines (e.g. clinical section of the investigator’s Brochure, assigned Protocols, Protocol amendments case report form, data review report, and Clinical Study Reports, etc.).
    • Provide the clinical input to functional portions of the Clinical Development Plan (study design, regulatory interactions) with attention towards the timely and quality execution of the plan through interaction with Study Team Members.
    • Establish an appropriate medical and study protocol training for the study team and selected CRO. Establish a medical monitoring plan with the selected CRO for the assigned studies. Provide oversight of medical monitoring activities.
    • Ensure the safeguard of Patients Safety: in collaboration with and in support of Pharmacovigilance, identify safety signals, review narratives, lend appropriate and sound medical interpretation, and take actions with investigators and/or data safety monitoring boards when Serious/unexpected Adverse Events are reported, ensure a full understanding of key Adverse Events and Serious Adverse Events and appropriate actions.
     

Experience Required

A significant experience in clinical or academic research. At least 3 years in clinical drug development preferred although equivalent expertise in clinical academic research will be considered.
Experience within the respiratory therapeutic area.

Education

Medical Doctor Degree; certification in Respiratory Diseases/Pulmonology will represent a plus

Languages

English Fluent 

Technical Skills

  • Experienced in writing protocols/reports, preparing clinical development plan, reviewing literature, authoring the clinical sections of the investigator’s brochure (IB), Data Safety Update Report (DSUR), and regulatory documents. Ability to interact with academic and regulatory experts with confidence, integrity and persuasion.
  • Proficiency in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance
  • Proficient in MS Office (Word, Excel, PowerPoint), Adobe and Outlook.

Soft Skills

  • Adaptability and flexibility
  • Attention to details
  • Communication skills
  • Goal orientation
  • Problem solving
  • Stress management
  • Team working 
Degrees of interest: Laurea in Medicina. In particolare Specializzazione in Pneumologia.

To apply to this opportunity, just click on APPLY. Before clicking, you can add a motivation letter. It's recommended but not compulsory.

Important: if the job description is in english, than also the motivation letter and the cv saved into the platform must be in english.


Apply