Snr Dir Early Clinical & Translational Medicine

The Senior Director, Early Clinical & Translational Medicine is a highly strategic and influential senior medical leadership role within R&D. The position within the Clinical Pharmacology & Early Development (CPED) function, is focused on both providing and leading crucial clinical and translational medicine input to early stage R&D projects (typically from mid-stage Research up to clinical proof-of-concept). Key features of this role are: 
• 
be medically qualified, with at least 8 years relevant clinical development experience in pharma; 
• 
be involved, by direct clinical leadership of a program or through management of direct reports (including the roles of Early Clinical Development Lead, Early Clinical Development Physician and Clinical Translational Physician), in a wide range of early R&D pipeline projects, 
• 
ability to independently lead an Early Clinical Dev program by utilising proven, advanced experience involving innovative strategy, matrix team and operational leadership 
• 
have a thorough understanding and proven experience to independently undertake Regulatory Agency interactions; 
• 
work in close collaboration with Research, Clinical Development (CD) functions, Regulatory Affairs, Non-Clinical Development, Product Development, Commercial/ Business Development and Project Management; 
• 
ability to lead medical monitoring work; 
• 
ability to independently present and defend clinical strategies to senior colleagues and governance committees; 
• 
have a thorough understanding of, and advanced experience in, the application of translational medicine methods to programs 
• 
ability to form strategic relationships with world-leading KOLs to advance programs. 
• 
ability to apply Commercially-based thinking to clinical program and disease area strategy; 
• 
provide leadership for first-in-human (FIH) study conduct and , when required, lead Early Clinical Developments FIH Committee; and 
• 
have a proven ability to provide medical knowledge in a range of areas, including (though not solely) immunology, respiratory and hematology. 
The Senior Director, Early Clinical & Translational Medicine is a highly strategic and influential senior medical leadership role within R&D. The position within the Clinical Pharmacology & Early Development (CPED) function, is focused on both providing and leading crucial clinical and translational medicine input to early stage R&D projects (typically from mid-stage Research up to clinical proof-of-concept).

Requirements: 

Key features of this role are: 

•be medically qualified, with at least 8 years relevant clinical development experience in pharma; 
•be involved, by direct clinical leadership of a program or through management of direct reports (including the roles of Early Clinical Development Lead, Early Clinical Development Physician and Clinical Translational Physician), in a wide range of early R&D pipeline projects, 
•ability to independently lead an Early Clinical Dev program by utilising proven, advanced experience involving innovative strategy, matrix team and operational leadership 
•have a thorough understanding and proven experience to independently undertake Regulatory Agency interactions; 
•work in close collaboration with Research, Clinical Development (CD) functions, Regulatory Affairs, Non-Clinical Development, Product Development, Commercial/ Business Development and Project Management; 
•ability to lead medical monitoring work; 
•ability to independently present and defend clinical strategies to senior colleagues and governance committees; 
•have a thorough understanding of, and advanced experience in, the application of translational medicine methods to programs 
•ability to form strategic relationships with world-leading KOLs to advance programs. 
•ability to apply Commercially-based thinking to clinical program and disease area strategy; 
•provide leadership for first-in-human (FIH) study conduct and , when required, lead Early Clinical Developments FIH Committee; and 
•have a proven ability to provide medical knowledge in a range of areas, including (though not solely) immunology, respiratory and hematology. 

 

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