Therapeutic Area Lead (Gastroenterology)

Remote from: USA
Annual salary: Undisclosed
Salary information is not provided for this position. Check our Salary Directory to estimate the average compensation for similar roles.
Department: Healthcare & Medical
Employment type: Full Time,
Job posted: 25 Jun 2026
Apply before: 25 Jul 2026
Experience level: Senior
Views / Applies: 41 / 9

About company

About PSI CRO

Predictable patient enrollment across multiple therapeutic areas.

Pharmaceuticals
1995

Actively Hiring

AI Summary

This senior-level role at PSI involves leading the strategic development of the Gastroenterology therapeutic area, with a focus on Inflammatory Bowel Disease. The successful candidate will serve as a scientific and strategic expert, partnering with Business Development, Clinical Operations, and study teams. Responsibilities include shaping long-term GI strategy, supporting client engagement, and providing therapeutic guidance to project teams. The position requires at least 6 years of experience in gastroenterology within a clinical research environment, and offers a unique opportunity to combine scientific expertise with business impact.

Role DNA

Job Complexity

Easy Hard

Pace & Pressure

Relaxed Fast-paced

Autonomy Level

Guided Full Ownership

Communication Load

Independent Highly Collaborative

AI Insight The role demands deep scientific knowledge, strategic thinking, and client interaction, requiring a high level of expertise and experience.

Salary Analysis

AI Insight No salary range was provided. Based on market data for senior Therapeutic Area Lead roles in the CRO industry, the estimated median salary is $175,000, which is competitive for this specialized position.

Key Skills

Gastroenterology Inflammatory Bowel Disease Clinical Research Strategic Planning Business Development KOL Management Protocol Review Cross-functional Collaboration CRO Expertise Therapeutic Area Strategy

Cover Letter Sample

Dear Hiring Manager,

I am writing to express my strong interest in the Therapeutic Area Lead (Gastroenterology) position at PSI. With over 6 years of experience in inflammatory bowel disease research and clinical development, I have a deep understanding of both the scientific and strategic aspects of GI drug development. I have successfully led cross-functional teams, contributed to business development efforts, and developed key opinion leader networks.

My background includes extensive protocol review, site selection, and investigator meeting participation, aligning perfectly with the responsibilities outlined. I am excited about the opportunity to shape PSI's GI strategy and drive operational excellence. I would welcome the chance to discuss how my expertise can contribute to your team.

Sincerely,
[Your Name]

Possible Interview Questions

How would you approach developing a long-term strategy for the Gastroenterology therapeutic area at PSI?

I would start by analyzing current market trends, competitor activities, and unmet medical needs in GI, particularly in IBD. Then, I would collaborate with internal stakeholders to identify key growth areas, potential partnerships, and operational efficiencies. Regular review of clinical trial data and KOL feedback would inform iterative strategy adjustments.

Can you describe your experience with investigator meetings and how you ensure alignment across study teams?

I have participated in numerous investigator meetings, where I presented scientific rationale and study design. To ensure alignment, I facilitate pre-meeting syncs, address questions clearly, and follow up with detailed meeting minutes. I also work closely with clinical operations to ensure consistent messaging across all sites.

How do you stay current with the latest developments in Gastroenterology, and how would you leverage that knowledge at PSI?

I regularly attend major GI conferences like DDW and UEG Week, read key journals, and engage with KOLs. I would share insights through internal briefs, contribute to proposal development, and advise study teams on emerging science, ensuring our studies remain competitive and relevant.

Describe a time when you had to manage a challenging client relationship. How did you handle it?

In a previous role, a client was dissatisfied with study enrollment rates. I arranged a meeting to understand their concerns, presented a data-driven analysis of delays, and proposed a joint action plan. By demonstrating transparency and proactive problem-solving, we rebuilt trust and exceeded enrollment targets.

What is your experience with protocol feasibility and site selection in GI studies?

I have conducted protocol feasibility by evaluating patient populations, site capabilities, and regulatory requirements. For site selection, I use a combination of historical performance metrics, KOL input, and site surveys. This ensures we select sites that can recruit and execute efficiently.

Company Description

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.

Job Description

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.

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.

Additional Information

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.

Apply now >