Therapeutic Area Lead (Gastroenterology)

Role Summary

The Therapeutic Area Lead is responsible for supporting the strategic development of PSI's core indications and serves as a core support function. As PSI continues to expand its Gastroenterology portfolio, we are seeking a Therapeutic Area Lead with expertise in Inflammatory Bowel Disease (IBD), particularly Ulcerative Colitis and Crohn's Disease, to serve as a scientific and strategic subject matter expert across the organization.

This highly visible role partners with Business Development, Proposal Development, Clinical Operations, and Study Teams to support growth initiatives, client engagement, therapeutic strategy, and operational excellence within the GI therapeutic area.

The successful candidate will help shape PSI's long-term GI strategy while serving as a trusted advisor to both internal stakeholders and external clients.

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.
• 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.
• 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.

Join a growing therapeutic strategy function and play a key role in shaping PSI's Gastroenterology portfolio. This is a unique opportunity to combine scientific expertise, strategic thinking, and business impact while collaborating with sponsors, investigators, and cross-functional teams across the organization.

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together close to 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

About the Company

Why Join PSI?

At PSI, we believe exceptional people deserve an exceptional workplace.

When you join PSI, you'll benefit from

A stable, privately held CRO that has never undergone a merger or acquisition and has never experienced company-wide layoffs.

A unique leadership-focused CRA role with minimal travel and little to no routine site assignments.

Opportunities to mentor other CRAs and expand your leadership skills.

A collaborative, people-first culture where employees are genuinely supported.

Career development opportunities across a growing global organization.

The chance to contribute to innovative clinical research that improves patients' lives.

We are the company that cares - for our staff, our clients, our partners, and the quality of the work we do.

Founded in 1995, PSI CRO is a privately owned, global Contract Research Organization with more than 3,000 employees dedicated to advancing medical science and bringing new therapies to patients worldwide.

In an industry shaped by mergers, acquisitions, and restructures, PSI stands apart. We have remained privately held, have never undergone a merger or acquisition, and have never experienced company-wide layoffs. Our long-term stability allows us to invest in our people, foster meaningful careers, and build lasting partnerships with our clients.

If you're looking for a collaborative organization where you can continue to grow while making a meaningful impact, PSI is the right place for you.