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PSI CRO
Therapeutic Area Lead (Gastroenterology)PSI CRO • São Paulo, São Paulo, Brazil
Therapeutic Area Lead (Gastroenterology)

Therapeutic Area Lead (Gastroenterology)

PSI CRO • São Paulo, São Paulo, Brazil
Há 2 dias
Descrição da vaga

The Therapeutic Area Lead is responsible for supporting the strategic development of PSIs 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 Crohns 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 PSIs 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 PSIs 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 Crohns Disease.
  • Strong English communication skills required (written and verbal).
  • 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 PSIs 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.


Remote Work :

Yes


Employment Type :

Full-time


Experience: years
Vacancy: 1

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Therapeutic Area Lead (Gastroenterology) • São Paulo, São Paulo, Brazil

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