Rare Disease Clinical Research Physician

Purpose

-    Support the clinical team in relevant medical and scientific aspects of the assigned global clinical studies within the global clinical development program 
-    Contributes to the risk/benefit assessment of the ongoing clinical trials assigned 
-    May act as the primary medical monitor for an assigned clinical study
-    Contributes to the production of the Common Technical Document, in terms of validation of scientific documents relevant to the assigned clinical study (e.g. study protocol, investigator’s brochure, clinical study reports) and represents the company in front of health authorities, partners and institutions
-    Develops and enhances the management of the clinical trials, working in collaboration with the Clinical Program Leader and other relevant roles and ensures medical and scientific validity of the assigned clinical studies in terms of design, conduct and interpretation. 
 

Main Responsibilities

-    Acting as a member of the program meetings and/or Clinical Study Team, in cooperation with other Study Team Members, to support the design, conduct and analysis as well as data interpretation of assigned clinical studies, including the preparation of key relevant clinical documentation, in accordance to the Clinical Development Plan and agreed timelines (e.g. clinical sections of the Investigator’s Brochure, clinical section of the Investigational Medicinal Product Dossier, protocols, protocol’s amendments, clinical study reports)
-    Conducting medical and scientific review on the data of the ongoing and completed clinical trial data with the appropriate oversight from the Clinical Program Leader (CPL)
-    As a clinical expert, supporting the CPL in interactions with internal and external stakeholders acting as the subject matter expert in the assigned product(s) and relevant disease(s) area, maintaining and enhancing knowledge in relevant technical or therapeutic areas and in global regulations/guidelines.
-    Interfacing a diverse range of scientific external experts (e.g., regulatory, payors, CROs, consultants, investigators) in order to deliver clinical programs and align on business strategy and address patients’ needs
-    Identifying potential trends and support internal decision making, securing timely publication of clinical data according to the agreed publication plan.
-    Ensure the development of a robust, optimized, efficient and innovative trial designs, including selection of clinical endpoints, patients populations and medical monitoring strategy, partnering with all relevant disciplines, as well as upholding Company standards, standard operating procedures, and agreed key performance indicators. 
-    Support in the design of post-registration clinical studies to secure the growth of the brand according to the life-cycle management of the product and the relative clinical development plan.  

Experience Required

2+ years of experience as Clinical Research Physicians/Medical Monitor in Pharmaceutical Companies or Clinical Research Organizations
•    Relevant experience in clinical or academic research in rare diseases 
•    Experience in Clinical Development (clinical trial design, conduct and interpretation)

Education

Medical Doctor Degree is required; 
Preferred Specializations (not binding), Internal Medicine, Nephrology, Cardiology, Pediatrics, Immunology, Neurology
Past experience in Rare Diseases (clinical or in the pharmaceutical field) is desirable

Languages

English fluent

Soft Skills