Physician, Medical Director – MedSpas
Moxie
Associate Medical Director, Clinical Development, CV
Novartis
full-time
Posted on:
Origin: • 🇨🇭 Switzerland
Visit company websiteJob Level
Lead
About the role
- Accountable for all country clinical/medical aspects associated with programs/trials by providing clinical strategic and tactical leadership
- Gather, inform, and act on clinical/medical/scientific insights for clinical trial concept sheets, protocols, Informed Consent Forms (ICFs) and other clinical documents to optimize trial implementation
- Drive identification and involvement of qualified investigators with highest recruitment potential and address recruitment hurdles
- Ensure adherence to safety standards and clinical data quality in the country and provide general clinical/medical support for trial-related safety findings
- Collaborate with clinical trial operations, Medical Affairs and Patient Engagement to enable fast trial start-up, timely recruitment, resource allocation, early delay identification and mitigation planning
- Validate study designs and make final decisions on clinical/medical trial and program feasibility based on country medical practice and competitive analysis
- Provide clinical/medical expertise for IRB/EC interactions and decide site/Country-specific scientific/medical content of ICFs
- Interact with external Country Experts, Regulatory Authorities, Medical Experts, Advisory Boards and Patient Advocacy Groups
- Develop clinical/medical trial plans accounting for the broader ecosystem and provide indication/compound/protocol training
- Leverage innovation in trial planning and decide on clinical/medical recruitment strategy using physician interviews, competitive trial analysis and patient engagement
- Support planning, implementation, and follow-up of Regulatory Authority inspections and internal audits
- Review and resolve Country trial-related scientific/clinical/medical issues; escalate to Global Clinical Development team as necessary
- Support Global team on Protocol Deviations follow-up with clinical trial sites and may assess Country datasets (registries, EHRs, payer data, RWD) for innovative study designs
Requirements
- MD/DO or equivalent
- Training in cardiology preferred
- Knowledge and clinical training in siRNA desirable
- Demonstrates knowledge of how to adequately review and read a protocol to understand study design and answer trial questions
- Applies detailed understanding of the drug to provide medical context related to disease processes, populations, and standards of care
- Ability to assess feasibility of implementing a protocol based on Country medical practice and Clinical Development Plan
- Demonstrates high level understanding of the protocol to train others, including site personnel
- Demonstrates understanding of protocol compliance, Investigator/site staff/study participant responsibilities, and patient safety issues
- Demonstrates understanding of Regulatory requirements and internal policies, procedures, and guidelines for clinical trials
- Demonstrates current knowledge of relevant Country regulations and compliance requirements and communicates to Global teams as required
- Demonstrates knowledge of applicable SOPs, policies, procedures, and guidance documents
- Expertise to represent the company as safety expert to Regulatory Authorities, Health Boards, and REB/EC
- Experience providing clinical/medical support for trial safety findings and protocol deviations
