SVP of Clinical Development - Cell Therapy

QP Group; United States; On-site; USD 200,000 - 300,000; Full time

Job summary

QP Group is seeking a Senior Vice President of Clinical Development to lead the clinical strategy across various regenerative medicine programs. This role involves overseeing Phase 1/2 clinical trials and ensuring compliant execution while building a robust Clinical Development organization.

The ideal candidate will possess an MD (MD/PhD preferred) and at least 12 years of experience in clinical development, demonstrating leadership skills and expertise in regulatory interactions.

Qualifications

• 12+ years of experience in biotech or biopharmaceutical Clinical Development.
• Significant leadership experience in early- and mid-stage clinical programs.
• Experience interacting with global regulatory authorities.

Responsibilities

• Lead clinical development strategy across regenerative medicine programs.
• Oversee Phase 1/2 trial design and execution.
• Provide leadership for IND strategy and FDA engagements.

Skills

Leadership in Clinical Development

FDA Interactions

Clinical Strategy Development

Protocol Design

Translational Medicine

Education

MD or MD/PhD

Job description

SVP of Clinical Development Opportunity

A clinical-stage biotechnology company developing regenerative and cell-based therapies for cardiovascular and rare diseases is actively looking to appoint a Senior Vice President of Clinical Development to lead overall clinical strategy and execution across its pipeline. The SVP of Clinical Development will oversee Phase 1/2 clinical programs, including programs focused on cardiomyopathy and rare disease indications, while building and scaling the Clinical Development organisation as the company advances toward later-stage development and long-term corporate growth.

Responsibilities

• Lead overall clinical development strategy across multiple regenerative medicine and cell therapy programs.
• Oversee the design, execution, and interpretation of Phase 1/2 clinical trials, including protocol development, endpoint strategy, and clinical data review.
• Provide leadership for IND strategy, FDA interactions, and global regulatory engagement activities.
• Serve as the primary clinical representative to investigators, key opinion leaders, advisory boards, partners, and regulatory agencies.
• Oversee CROs, vendors, and external clinical partners to ensure compliant and efficient trial execution.
• Partner closely with Clinical Operations, Regulatory Affairs, Translational Sciences, Biometrics, CMC, and Executive Leadership.
• Support clinical planning for future late-stage development and potential commercialisation readiness.

Experience Required

• MD required; MD/PhD strongly preferred.
• Minimum 12+ years of experience within biotech or biopharmaceutical Clinical Development, with significant leadership experience in early- and mid-stage clinical programs.
• Prior experience in regenerative medicine, cell therapy, biologics, gene therapy, or advanced therapeutics preferred.
• Demonstrated experience interacting directly with FDA and other global regulatory authorities.
• Experience leading clinical strategy, protocol design, and cross-functional clinical execution.
• Strong understanding of translational medicine and development pathways for rare disease and/or cardiovascular indications.
• Prior experience managing CROs and external development partners.