Job Description

Job Summary:

Responsible for the strategy, planning, and implementation of the companys clinical research programs. Lead clinical strategist for product research and development programs. Primary contact with corporate partners on clinical aspects of the companys commercial product(s).

Responsibilities:

• Oversee the development of the strategy for the companys clinical research and development programs
• Oversee the operations and management of the companys clinical trials, including protocol development, analysis plan, data collection and analysis, and clinical study reports, ensuring compliance with Good Clinical Practice and all applicable regulatory standards.
• Work with the regulatory affairs group to prepare regulatory documents and submissions required to support the companys clinical programs and product approval.
• Serve as a clinical strategist for the development of the companys product candidates.
• Serve as and clinical strategist for all business development activities, including assessments of therapeutic candidates for development by the company.
• Lead product Life-Cycle-Management and KOL Development
• Serve as lead clinical liaison to clinicians, thought leaders, and other companies.
• Serve as lead clinical/scientific reviewer of all company scientific publications and product labeling.
• Hire staff necessary to meet the companys clinical research and development objectives.

• Significant experience in the design and management of clinical trials
• Product development experience from preclinical to clinical stage
• Understanding of regulatory requirements
• Excellent written and verbal communication skills.
• Knowledge of clinical trials operations
• Significant assessment and risk management experience
• Ability to work with company management, regulatory agencies, and the community at large.
• Ability to establish clinical and scientific department policies and procedures.
• Strong manager and leader, capable of working with complex problems and solutions.

• MD or PhD degree; 10+ years of industry experience in clinical development, and R&D, with increasing experience in role and responsibility
• Experience with drug delivery technologies, and experience with pulmonary delivery a plus
• Experience with clinical pharmacology and drug safety is a plus.

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods of standing.
• Must be able to lift up to 15 pounds at times.
• Must be willing to travel frequently.

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