Careers at Pharmasset

• Design Phase II-IV clinical studies.
• Liaise with Key Opinion Leaders and external investigators to develop study concepts and proposals for investigator initiated studies.
• Analyze data, interpret results, and first-author clinical documentation, including but not limited to: clinical protocols, study reports, abstracts and manuscripts, presentations, clinical research components of investigator brochures, other NDA documents, and various other internal and external documents and communications, as needed.
• Work with Clinical Operations to help develop the operational strategies for clinical research studies and development programs (e.g., investigator selection, CRO selection, budgets).
• Assist in management of program timelines and budgets for clinical research to meet or exceed time, quality and fiscal objectives.
• Assure cross-functional alignment for Clinical Research studies and activities with other functional areas involved in clinical development programs, within Pharmasset and at intercompany interfaces.
• Perform related duties, special projects and/or other functions as required.

• MS, PharmD or PhD in a health-related field with a minimum of 5 or more years of related industry experience is required.
• Thorough command of good clinical research principles and their integration in the clinical drug development process is essential. Candidate must have demonstrated expertise in design, analysis and reporting of clinical research studies. Demonstration of creative study design to substantially shorten timelines, or development of a compound in a new therapeutic area would be highly considered.
• Substantial technical writing experience is essential - documented first authorship of protocols, study reports, regulatory communications, and manuscripts. NDA submission experience is preferred.
• Familiarity with regulatory issues related to Phase II-IV clinical research is essential.
• Demonstrated success in the management of CMC regulatory submissions, including previous experience filing NDA’s, IND’s, amendments, etc. and interacting with regulatory authorities.
• Demonstrated leadership and team management skills.
• Excellent communication (verbal and written), presentation, and organizational skills are essential.
• Therapeutic area (anti-infective, anti-viral) training and experience are desirable.
• Clinical budget and project management skills are desirable.
• Demonstrated ability to work effectively in a team environment, manage multiple priorities, exercise sound judgement, be well organized, take initiative, be flexible, work well under pressure and produce accurate and timely work.

Pharmasset, Inc. is an Equal Opportunity Employer.