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Executive Director, Clinical Science

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: Apellis Pharmaceuticals
Full Time position
Listed on 2026-03-06
Job specializations:
  • Software Development
    Data Science Manager
Job Description & How to Apply Below

Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases.

Summary:

The Executive Director, Clinical Science is a senior enterprise leader accountable for scientific rigor, executional excellence, and organizational performance across Clinical Development. This role partners closely with Pipeline and Asset Strategy teams to ensure early clinical programs, from first-in-human through proof-of-concept, are strategically designed, well executed, and deliver decision-ready data.
This leader establishes and leads the Clinical Science Center of Excellence (CoE), which serves as the scientific backbone of Clinical Development in a therapeutic area-agnostic manner. The Clinical Science CoE is the steward of clinical development science, ensuring consistency, quality, and best practices across the portfolio.
In addition, the Executive Director is responsible for continuously strengthening the early development engine, with accountability for operational execution, decision quality, and integration across functions during early clinical development. The role requires enterprise thinking, executive judgment, scientific credibility, and the ability to move fluidly between strategic partnership and hands-on program leadership. This leader shapes organizational culture by promoting scientific rigor, accountability, collaboration, and speed with quality.

Roles and Responsibilities:

Clinical Science Leadership

  • Serve as functional head of Clinical Science, accountable for performance, quality, and talent development across the portfolio.
  • Establish and uphold scientific rigor and consistency across clinical programs.
  • Lead, mentor, and develop Clinical Scientists and, when appropriate, therapeutic area agonistic junior Medical Directors.
  • Define, implement, and continuously improve clinical science standards, best practices, and governance.
  • Ensure high-quality data review, clear benefit-risk framing, and actionable recommendations to support development and regulatory decisions.
  • Translate portfolio priorities into resourcing strategies, capability development, and measurable objectives.
  • Build robust talent pipelines through hiring, development, and succession planning.

Early Clinical Development Leadership

  • Enable and support enterprise early development activities in close partnership with Pipeline Strategy, Asset Teams, and therapeutic area leads.
  • Ensure early clinical trials are designed to effectively translate biology into decision-ready clinical evidence.
  • Integrate Clinical Pharmacology, Biostatistics, Biomarkers, Translational Sciences, Regulatory, and other functions to deliver coherent dose and development strategies.
  • Provide oversight and clinical input of Clinical Pharmacology, ensuring strong clinical context for PK/PD, exposure-response, dose justification, and model-informed development in collaboration with subject matter experts.
  • Establish fit for purpose early development processes, standards, and governance to enable efficient learning, rapid risk reduction, and high-quality decision making.
  • Provide scientific oversight of early phase studies, ensuring alignment with target product profiles and downstream development needs.
  • Partner with Research and Pipeline Strategy to ensure seamless transition of assets into early clinical development.
  • Ensure early programs generate data that clearly support go/no-go and phase transition decisions.
  • Support the establishment of new therapeutic areas by providing appropriate early clinical development leadership and infrastructure.

Organizational and Operating Model Leadership

  • Strengthen the Clinical Development operating model to improve speed, rigor, accountability, and cross-functional alignment.
  • Improve decision quality, clarity of tradeoffs, and follow-through across early development programs.
  • Mentor emerging leaders to build enterprise leadership capability.
  • Promote disciplined benefit-risk assessment, feasibility evaluation, and contingency planning.
  • Oversee functional resourcing and provide budget input across Clinical Science and early development activities.
  • Build strong external relationships with CROs,…
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