About this role.
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
A quick view of the complexity, pace, ownership and collaboration implied by the job description.
Job Complexity
4/5Pace & Pressure
4/5Autonomy Level
4/5Communication Load
5/5Salary analysis
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Core skills
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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]
Sample interview questions
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.
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.
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.
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.
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.
Annual salary information is not provided for this position. Explore salary ranges for similar roles in our Salary Directory ›
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