Therapeutic Area Lead (Gastroenterology)

Responsibilities

• Supports indication-specific strategy planning and implementation across the assigned therapeutic area
• Attends conferences in the therapeutic area and reviews supporting literature
• Compiles datasets, metrics, lessons learned, and performance indices on core strategic capabilities and key studies within the given therapeutic area
• Serves as a scientific and strategic subject matter expert across the organization
• Supports project teams within assigned indications to advise on therapeutic strategy and study-specific mitigation strategies
• Supports the evaluation and selection of investigative sites
• Participates in Investigator Meetings and key team meetings
• Performs protocol analysis and escalates risks to senior management
• Reviews essential study documents and technical manuals
• Performs background research on epidemiology and other aspects of the given indication
• Supports client engagement and business development from a therapeutic area perspective
• Participates in proposal development and bid defense meeting preparations
• Supports PSI’s KOL networks within the assigned therapeutic area

Qualifications

• College or university degree in Life Sciences; advanced scientific degree or clinical degree is a plus
• At least 6 years of experience in Gastroenterology within academia, clinical practice, laboratory, biotechnology, pharmaceutical, CRO, or clinical research environments
• Demonstrated experience within Inflammatory Bowel Disease, particularly Ulcerative Colitis and Crohn’s Disease
• Strong scientific and analytical capabilities
• Ability to review and interpret clinical protocols and study documentation
• Strong written and verbal communication skills
• Ability to build effective relationships with internal and external stakeholders
• Ability to work effectively across multiple functional teams
• Proficiency in standard MS Office applications