US Clinical Program Lead CRM, Medical Director

Job Description Summary

About the role :
Remote Position

In this key clinical development role, the Clinical Program Lead will focus on Cardiovascular Development Program
• Actively contribute to successful trial performance from a clinical quality and recruitment perspective with a focus on clinical activities
• Drive US insights into Global Development trial concept sheets/protocols, Clinical Development Plans (CDP) and other relevant clinical documents.
• Co-Lead a US local cross-functional team to bring alignment of US MA (Medical Affairs), SSO (Study & Site Operations), and Development on US clinical development program strategy/tactics.
• Lead a smaller team of Clinical Research Medical Directors as direct reports

 

Job Description

Your Key Responsibilities:

Clinical Development Strategy:
• As Country Clinical expert and member of core GCT (Global Clinical Team), supports GPCH (Global Program Clinical Head) or CDH (Clinical Development Head) and works closely with CDD (Clinical Development Director)/CDMD (Clinical Development Medical Director).
• Is accountable to bring continuous US strategic and executional input into CDPs/concept sheets/protocols/trials and provide insights for clinical / medical / patient perspective about trial design and programs for successful execution in US, inc. diversity.
• Co-Leads local cross-functional trial team Country Program Team (Local CPT) to ensure close collaboration and clear Roles & Responsibilities between SSO and MA to support GDD trials.
•Accountable for essential clinical/medical activities for Development and Biomedical Research priority clinical trials including feasibility, clinical/medical recruitment activities, protocol execution in US including answering protocol related questions and addressing critical safety related topics.
• Training
• Ensures program specific global Clinical Research Medical Advisor (CRMA) excellence and bidirectional communication from CRMA community to GCT (indication / protocol / competitor trainings, clinical medical recruitment activities, lessons learned etc.) with support from assigned regional CRMAs.

Stakeholder Management
• Act as the key scientific/clinical/medical point of contact for prioritized GDD clinical trial sites and provides knowledge on the company’s pipeline programs to these sites.

This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 50% travel.

Role Requirements:

• MD/DO; PhD, PharmD or equivalent degree required. Subspecialty training desirable in Cardiology
• Training in relevant aspects of clinical drug development including GCP, Country regulatory requirements …