Clinical Research Medical Director – Biosimilars

Clinical Research Medical Director – Biosimilars

Responsibilities:
• Supporting the development, execution and communication of the global clinical plan
• Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
• Participating and providing clinical input into safety and regulatory interactions
• Supporting the development of key scientific external relationships with opinion leaders
Key Activities
• Provide clinical/scientific input during the development and execution of clinical trials
• Interpret clinical trial data
• Participate in safety assessments
• Participate in interactions with regulatory agencies
• Author regulatory submissions and publications and study related documents
• Develop key opinion leaders and make scientific presentations at various venues
• Support in-licensing and partner relationships
• Support product lifecycle management

Basic Qualifications :

• MD with clinical experience in Rheumatology
• Three (3) or more years of clinical research experience in biotechnology/pharmaceutical industry or CRO company

Preferred Qualifications:

• MD plus accredited residency in Rheumatology, board certified or equivalent
• Five (5) or more years of clinical research experience in biotech/pharma/CRO company and basic science research combined with clinical teaching or patient care activities
• Experience in all phases of clinical research (Phase 1-4)
• Experience interacting with FDA and international regulatory agencies
• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics
• Sound scientific and clinical judgment
• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• Demonstrated ability as a medical expert in a complex matrix environment
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues