Job Description:
Currently we are looking for the Vice President, Clinical Operations. This position has overall responsibility and accountability for activities within the Company related to designing, implementing and executing all human clinical trials conducted by it or on its behalf for the development of its clinical-stage product candidates worldwide. The position currently reports directly to the President/CEO and is a member of the executive team.

This position is responsible for the day to day management of clinical development strategies and plans, with activities ranging from the filing of investigational new drug applications (INDs) through Phase I-III clinical trials, the filing and approval of new drug applications (NDAs) and post-approval studies. While the emphasis of these responsibilities is on clinical development, an integral part of this role is active participation in pre-clinical development strategy and evaluation of new product development opportunities from a clinical perspective, as well as direct interaction with FDA with respect to the advancement of the Company's product candidates through all stages of clinical development. Due the fact that the Company has largely adopted a virtual operating model with respect to its clinical development activities, the individual in this position must have experience and a track record in identifying, negotiating with and managing clinical research organizations, consultants, and other similar vendors of outsourced activities.

RESPONSIBILITIES:

• Provide overall managerial oversight and leadership of the clinical development team(s).
  
• Plan, design and execute the organization's clinical developments strategy.
  
• Co-ordinate medical and scientific aspects of clinical development, including: medical safety, biostatistics, data management, and communications,
  
• Participate in all regular executive team meetings
  
• Provide executive team with reports as to the status of the Company's clinical development programs as needed
  
• Manage 2-3 internal staff and "outsourced" vendors
  
• Identify, negotiate with and engage qualified clinical research organizations
  
• Present to and interact with Board of Directors when needed
  
• Any other responsibilities assigned by the President/CEO

REQUIREMENTS:

• Masters Degree with related work-experience in at least one specialty relevant to the clinical indication(s) under study.
  
• 15 years of related work experience within a pharmaceutical or bio-pharmaceutical company, or a clinical research organization.
  
• Experience with small-molecule, anti-viral drugs preferred
  
• Ability to effectively present clinical strategy, design and rational to Board of Directors and institutional investors
  
• Demonstrated team player
  
• Expert knowledge of clinical trial design, conduct, and analysis
  
• Significant experience in the conduct of clinical trials in the U.S. and abroad
  
• Knowledge of Good Clinical Practices and regulatory (Federal and International) guidelines
  
• Significant experience in development and/or regulatory approval of new drugs
  
• Excellent communication skills (both written and verbal)
  
• Ability to coordinate with internal and external regulatory affairs professionals in a dynamic regulatory environment
  
• Ability to effectively lead and manage project teams, contract research organizations (CROs) and other similar vendors to which the organization outsources a number of critical functions
  
• Ability to travel extensively at times

We offer competitive salaries and a complete benefit package. Please email resumes to jobs@inhibitex.com. NO PHONE CALLS PLEASE

Job Description:
Currently we are looking for a Director, Regulatory Affairs. The successful candidate would be responsible for the following:

• Provide regulatory guidance throughout the product development and approval process, including nonclinical, clinical studies, CMC, etc.
  
• Serve as primary regulatory representative responsible for facilitating all regulatory agency interactions.
  
• Generate and direct the filing of regulatory submissions in electronic format to various regulatory agencies worldwide.
  
• Planning and timely submission of documentation to regulatory agencies to maintain development timelines and compliance with appropriate regulations.
  
• Interface with various regulatory agency representatives as needed.
  
• Keep abreast of new regulatory developments in the U.S. and abroad.
  
• Provide appropriate communication and guidance to management and other internal functional areas responsible for submitting required regulatory documentation.

Requirements:

• Bachelor degree or equivalent in a scientific, medical or life science field
  
• A minimum of 7 years direct experience in managing regulatory affairs within a pharmaceutical or bio-pharmaceutical organization.
  
• Track record of successful IND, CTA, CTD, and NDA filings
  
• Experience in electronic filings of IND's and successful interactions with CDER
  
• Experience with small molecule, anti-viral drug submissions preferred
  
• Recent relevant experience in coordinating and conducting regulatory activities in a project team setting;
  
• Experience in matrix management environment and mentoring cross-functional teams
  
• Good working knowledge of US, Canada, and EU regulations and standards
  
• Excellent interpersonal, communication (written and oral), teamwork, leadership, organizational and negotiating skills
  
• Ability to manage changing priorities and multidisciplinary tasks
  
• Ability to thrive in an energetic, goal oriented, small company environment

We offer competitive salaries and a complete benefit package. Please email resumes to jobs@inhibitex.com. NO PHONE CALLS PLEASE.