Posted on 20 Jul 2026

SVP/VP Clinical Development

United States (Remote/Hybrid)
Permanent
$400,000

Key Responsibilities

  • Develop, refine, and execute integrated global clinical development plans (CDPs) for assigned programs.
  • Define target product profiles and registration strategies.
  • Provide medical and scientific leadership across all phases (I-IV) of clinical development.
  • Ensure timely and high-quality delivery from protocol concept through study report, regulatory submission, and lifecycle management.
  • Serve as the senior medical monitor and signatory. Lead the medical review and interpretation of clinical data.
  • Author/oversee key documents: protocols, IBs, clinical study reports, and regulatory submission modules (IND/CTA/NDA/BLA).
  • Directly line-manage and mentor a team of Medical and Clinical Operations. Foster a collaborative, high-performance culture. Provide strategic direction and oversight to the team, ensuring close functional alignment.
  • Lead the cross-functional Core Team. Collaborate effectively with Biometrics, Regulatory Affairs, Pharmacovigilance, CMC, and Commercial.
  • Manage overseas/global project components, including liaising with the regulatory bodies, CROs, sites, and internal regional teams.
  • Serve as the primary clinical representative with global health authorities (FDA/EMA/NMPA, etc.). Establish and maintain relationships with global Key Opinion Leaders (KOLs) and advisory boards.
  • Represent the company at major scientific conferences. Lead data disclosure strategy, including publications in high-impact journals. 

Qualifications 

  • MD or PhD in Clinical Medicine, Pharmacology, or a related life science field is required.
  • Must have experience in Gene therapy and Rare Disease
  • Solid experience in non-oncology clinical development is essential. Specific experience in immunology, metabolic, infectious, or rare diseases is highly preferred.
  • Minimum 10 years of experience in clinical development within the pharmaceutical or biotechnology industry. In-depth knowledge of GCP, ICH guidelines, and global regulatory requirements. Strong strategic thinking, problem solving, and analytical skills.
  • Demonstrated, hands-on experience leading the complete clinical development lifecycle from early-stage to NDA. Excellent project management and organizational abilities.
  • Substantial experience in managing overseas clinical development activities (e.g., US. EU), including direct interaction with the regulators and partners.
  • Proven experience in directly managing and developing teams, including both medical/scientific roles and experience providing matrix leadership or direct oversight to Clinical Operations functions. Strong people management and mentoring skills.
  • Fluent spoken English is mandatory, with the ability to lead international meetings, present complex data, and negotiate effectively. 

Benefits

  • 30% target bonus
  • Stock options
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