Director Clinical Development

Meet Life Sciences

United States

On-site

USD 180,000 - 230,000

Full time

11 days ago
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Job summary

Meet Life Sciences is seeking a Director of Clinical Development (Immunology & Inflammation) to lead a global Phase III program in atopic dermatitis. This role offers senior leadership visibility and a strategic mandate beyond study execution, influencing clinical strategy and regulatory readiness.

You will guide protocol design, data interpretation and communication to senior leadership, while partnering with Clinical Operations, Regulatory, Biostatistics and external investigators to deliver

Qualifications

  • PhD, PharmD or equivalent scientific doctorate preferred; exceptional candidates with equivalent industry experience will be considered.
  • Approximately 8–10+ years of research and/or clinical development experience.
  • Meaningful experience within late-stage clinical development.
  • Experience supporting at least one global Phase III study through start-up and/or database lock.

Responsibilities

  • Provide scientific leadership across a global Phase III program and bridge clinical strategy with study execution.
  • Lead the scientific design and oversight of global Phase III trials aligning with Target Product Profile.
  • Serve as a primary Clinical Development representative on Global Study Team.
  • Partner with Clinical Operations, Regulatory Affairs, Biostatistics and other functions to drive study execution and milestones.
  • Lead ongoing clinical data review, interpretation and signal detection for leadership recommendations.
  • Provide guidance on protocol interpretation, study conduct and site/investigator questions.
  • Support interactions with health authorities and respond to regulatory questions.
  • Contribute to protocols, Investigator Brochures, Clinical Study Reports and publications.

Skills

Clinical leadership
Cross-functional collaboration
Scientific communication
Regulatory interactions

Education

PhD/PharmD or equivalent doctorate

Job description

Director, Clinical Development | Immunology & Inflammation

We are partnering with an established, financially well-positioned biotechnology company to appoint a Director, Clinical Development to join its Late-Stage Development organization.

This is an exciting opportunity for an experienced Clinical Development professional to take a lead role on a global Phase III program in atopic dermatitis, working alongside an accomplished cross-functional team to advance a potentially important new therapy through pivotal development and toward NDA/BLA filing.

The position offers considerably more than study execution. You will serve as a key clinical and scientific leader for the program, with high levels of visibility across Clinical Development and senior leadership, and the opportunity to directly influence the strategy and execution of a major late-stage asset.

The Opportunity
  • As a key member of the Late-Stage Cross-Functional Team, you will provide scientific leadership across a global Phase III program and act as the bridge between clinical strategy and study execution. Key responsibilities will include:
  • Take a lead clinical/scientific role on a global Phase III study in atopic dermatitis, supporting the program through pivotal development and toward NDA/BLA submission
  • Lead the scientific design and clinical oversight of global Phase III trials, ensuring alignment with the broader Target Product Profile and development strategy
  • Serve as a primary Clinical Development representative on the Global Study Team
  • Partner closely with Clinical Operations, Regulatory Affairs, Biostatistics and other functions to drive study execution and key program milestones
  • Lead ongoing clinical data review, interpretation and signal detection, translating emerging findings into recommendations for senior Clinical Development leadership
  • Provide clinical and scientific guidance around protocol interpretation, study conduct and site/investigator questions
  • Support interactions with global health authorities and contribute to responses to regulatory questions
  • Contribute to protocols, Investigator Brochures, Clinical Study Reports, scientific presentations, publications and other key clinical documents
  • Engage with investigators, KOLs and study sites to support successful execution of the global development program
  • Contribute directly to the clinical documentation and activities required to support future NDA/BLA submissions
What We're Looking For
  • We are looking for an experienced Clinical Development professional who can combine strong scientific thinking with the ability to lead within a complex, global cross-functional environment.
  • Ideally, you will bring:
  • PhD, PharmD or equivalent scientific doctorate preferred; exceptional candidates with equivalent industry experience will also be considered
  • Approximately 8–10+ years of research and/or clinical development experience
  • Meaningful experience within late-stage clinical development
  • Experience supporting at least one global Phase III study through start-up and/or database lock
  • Strong clinical data review, interpretation and scientific communication capabilities
  • Experience developing and reviewing protocols, Investigator Brochures, study manuals, regulatory responses and other clinical documents
  • Ability to provide leadership and influence within a matrix environment without necessarily having direct-line authority

Experience within Immunology & Inflammation is highly desirable, with direct experience in atopic dermatitis particularly relevant.

Why Consider This Opportunity?

This is an opportunity to join a high-quality Clinical Development team with compelling science, strong financial resources and an important late-stage program approaching significant value-creating milestones.

For someone looking to build deeper registrational experience, the position provides the opportunity to have genuine ownership within a global Phase III program, gain exposure to senior development leadership and contribute directly to the work required to take an asset from pivotal development toward regulatory filing and potential approval.

The combination of late-stage ownership, strong science, financial stability and high internal visibility makes this a particularly compelling opportunity for someone looking to take the next step in their Clinical Development career.

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