Summary
About the Role
Major accountabilities:
Validates study designs, is accountable for, and makes the final decision on the clinical/medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.
Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up.
Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.
Decides on site/Country-specific scientific/clinical/medical content of the Informed Consent Form(ICF) as needed and ensures appropriateness of patient suitable language.
Provides scientific/clinical/medical expertise during interactions with Country/Cluster external Experts(e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
Building disease area expertise, especially for new/rare indications.
Provides robust indication, compound, and protocol training: To the clinical operations team in the country, especially to the Clinical Research Associates, and other country line functions as needed.
Supports planning, implementation, and follow-up of scientific/clinical/medical components of Regulatory Authority inspections and internal audits.
Reviews and resolves Country trial-related scientific/clinical/medical issues/questions. If necessary, initiates the discussion with the Global Clinical Development team.
May be involved in reviewing the clinical/medical aspects of clinical trial Serious Adverse Events (SAEs) occurring in the Country and supports the patient safety team, and Global as needed to ensure high quality of clinical/medical information.
Follows-up with the Investigator for additional clinical/medical information or clarifications for AEs and SAEs and provides clinical/medical expertise for safety amendments, Investigator Notifications (INs), Urgent Safety Measures (USM), etc. as needed.
Job Requirements:
MD or equivalent medical degree is required, in addition to a proven track record of clinical experience in and scientific contributions to your field of expertise.
Specialty training in Rheumatology is desired but not an absolute prerequisite.
Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice
Working knowledge in the area of Immunology and Inflammation with ability to interpret, discuss and present efficacy & safety data relating to clinical trials.
Sound understanding of the overall clinical development process, and ICH/GCP principles.
Ability to manage a study from the scientific/medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex scientific/clinical/medical/operational issues.
Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care.
Ability to assess the feasibility of implementing the protocol based on Country/Cluster medical practice and sound understanding of the overall Clinical Development Plan.
Demonstrates an understanding of the protocol to evaluate compliance on the part of the Investigator/site staff/study participant and any patient safety issues.
Demonstrates an understanding of Regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
