Gastroenterology Clinical Development Lead

Mixtalent

United States

On-site

USD 250,000 - 500,000

Full time

30 hours ago
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Job summary

Mixtalent seeks a Vice President, Clinical Development, Gastroenterology to shape and execute the clinical development strategy across early to registrational studies, reporting to the Chief Medical Officer. This role leads medical oversight of trials and interfaces with regulatory agencies, KOLs, investigators and internal teams to align programs with regulatory expectations and patient needs.

The successful candidate will mentor teams and contribute to lifecycle planning, while representing

Qualifications

  • MD or equivalent medical degree required.
  • Specialty in Gastroenterology; board certification preferred.
  • 5+ years of relevant clinical/biopharmaceutical experience including clinical drug development.
  • Demonstrated clinical lead experience for gastroenterology programs.
  • Strong understanding of trial design, regulatory requirements, and benefit–risk assessment.

Responsibilities

  • Lead the clinical development strategy and execution from Phase 1 through Phase 3.
  • Serve as medical lead for trials and integrated development plans; develop TPPs and lifecycle plans.
  • Provide medical oversight, safety monitoring, data review, and protocol interpretation for ongoing trials.
  • Collaborate with Regulatory Affairs, Clinical Operations, Translational Medicine, Biostatistics, and Medical Affairs.
  • Mentor clinical scientists and contribute to organizational strategy and due diligence activities.

Skills

Clinical development leadership
Clinical trial design
Biostatistics
Regulatory understanding
Leadership in matrixed teams
Scientific communication

Education

MD or equivalent

Job description

Mixtalent seeks a Vice President, Clinical Development, Gastroenterology to shape and execute the clinical development strategy across early to registrational studies, reporting to the Chief Medical Officer. This role leads medical oversight of trials and interfaces with regulatory agencies, KOLs, investigators and internal teams to align programs with regulatory expectations and patient needs.

The successful candidate will mentor teams and contribute to lifecycle planning, while representing

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