SVP Global Clinical Development: Hematology & Immunology

Cornerstone Search Group

Boston (MA)

On-site

USD 350,000 - 600,000

Full time

35 hours ago
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Job summary

Cornerstone Search Group has been retained by a high-profile, fully-integrated, well-funded public biotech to find an MD for the newly-created SVP, Head of Clinical Development role. The candidate will lead Phase II/III global development, oversee NDA/BLA submissions, lifecycle management, and post-approval studies, reporting to the CMO with a growing Medical Directors/Clinical Scientists team.

The role requires deep late-stage development expertise, strong regulatory experience, and the ability

Qualifications

  • MD or equivalent.
  • Training or clinical development experience in hematology or heme-onc is a plus; Immunology can compensate.
  • 10+ years of industry clinical development experience.
  • Pivotal trial track record: planning, initiation, and execution.
  • Regulatory filing track record: NDA or BLA experience.
  • Prior direct line management experience of Medical Directors/Clinical Scientists.
  • Experience presenting clinical strategy and data to executive leadership and BoD.
  • Antibody experience is a plus.
  • Prior clinical-stage or small pharma experience is a plus.

Responsibilities

  • Lead and manage Phase II and III global clinical development activities.
  • Oversee NDA/BLA submissions and lifecycle management.
  • Direct post-approval studies and long-term safety programs.
  • Manage Medical Directors and Clinical Scientists with a focus on high EQ and collaboration.
  • Collaborate with CMO and executive team in a fast-paced environment.
  • Travel US and globally as needed.

Skills

MD
Clinical development
Pivotal trial planning
Regulatory filings NDA/BLA
Medical director leadership
Hematology experience
Immunology experience
Executive presentation
Travel readiness

Education

MD degree

Job description

Cornerstone Search Group has been retained by a high-profile, fully-integrated, well-funded public biotech to find an MD for the newly-created SVP, Head of Clinical Development role. The candidate will lead Phase II/III global development, oversee NDA/BLA submissions, lifecycle management, and post-approval studies, reporting to the CMO with a growing Medical Directors/Clinical Scientists team.

The role requires deep late-stage development expertise, strong regulatory experience, and the ability

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