DESCRIPTION:
Responsible for all aspects of the Clinical Research and Operations successful submission of NDA and MMA for 2 indications which are global operations.

SPECIFIC RESPONSIBILITIES INCLUDE:
• Sponsor responsibility for execution of Phase III programs
• Provide leadership and oversight for the development operations team for on-time, on-budget, in full compliance (GCP, etc) of programs
• Manage global clinical trials
• Management of Phase III trials according to ICH, GCP and FDA requirements
• Clinical project management, including the selection of vendors, and the selection and interface of CROs
• Monitoring the progress of trials including enrollment and resource allocation and utilization
• Manage all budgets and provide progress updates to management
• Protocol development
• Investigator recruitment
• Development of consent forms and IRB materials
• Operating plans
• Randomization and clinical drug supply plans
• Case report form development and electronic data capture
• Data cleaning and database locking
• Coordinate development of statistical analysis plans
• Clinical studies report development
• Development and observance of internal SOPs related to trial management
• Supervision of clinical research associates (CRAs)
• Organize and lead project sub-team and CRO meetings as necessary
• Work closely with clinical research, preclinical research, manufacturing, quality assurance, and regulatory affairs in the execution of the clinical development program

QUALIFICATIONS:
EDUCATION/PROFESSIONAL SKILLS & EXPERIENCE
a. Licenses, certifications and degrees:
(Note: include academic degrees only if absolutely a job requirement.)
MS/PHD in biological sciences is required; or in a nursing degree or equivalent experience.

b. Role-related knowledge:
• 10-15 years of clinical research and operation experience
• Must have Phase III experience including submission of NDA and MMA ; will handle CF so knowledge in this area and/or Respiratory is a plus
• Experience of GCP/ICH guidelines and FDA regulations
• Experience with clinical trial design and data management required and basic knowledge of statistics is preferred
• Experience managing budgets for Phase III programs including oversight of CROs

c. Role-related (skills, abilities, behavior necessary to perform the role) including language, mathematical and reasoning (analytical) skills, intellectual, creative and/or communications abilities:
Must have demonstrable Leadership skills and be a team player with good organization skills and the ability to prioritize. Seasoned negotiating skills are required and the candidate must possess the ability to work with individuals from multiple groups to resolve conflicts and persuasively influence outcomes. Prior management experience and proven ability to coach and mentor team members is required. Strong oral and written communication skills are required. Must be able to thrive in a fast paced business environment and be a self-starter, detail-oriented, and motivated, with a commitment to excellence in research.