Executive Director, Clinical Development - AL Amyloidosis

Protego Biopharma, Inc.; San Diego (CA); On-site; USD 260,000 - 350,000; Full time

Benefits offered by this job

Stock options

Medical, dental, vision coverage

Disability insurance

Job summary

Protego Biopharma, Inc. seeks a Senior Director/Executive Director, Clinical Development to provide strategic leadership for the lead AL amyloidosis program.

The role demands an experienced physician-leader with a track record of Phase 2/3 and registration studies in a fast-moving biotech setting. You will align clinical strategy with regulatory expectations, oversee registration-quality trials globally, and collaborate across Clinical Ops, Biometrics, and Regulatory Affairs to ensure data

Qualifications

• MD required; Board certification preferred.
• 8+ years of clinical development experience in biotechnology/pharmaceuticals or CROs.
• Proven leadership of late-stage and registration-enabling trials, including global studies.
• Direct involvement in regulatory submissions (e.g., NDA, BLA, MAA) and health authority interactions.
• Experience leading programs through pivotal study initiation and registration readiness.
• Strong strategic thinking with the ability to integrate clinical, regulatory, and scientific perspectives.
• Deep understanding of global clinical development and registration pathways.

Responsibilities

• Define and drive the clinical development strategy for the lead program in AL amyloidosis.
• Translate data into clear development plans, milestone decisions, and risk-benefit assessments.
• Ensure alignment with regulatory expectations, target product profiles, and long-term portfolio objectives.
• Lead design and oversight of registration-quality trials with global development considerations.
• Provide senior clinical oversight to ensure trials meet quality, safety, and data integrity.
• Partner with Clinical Operations, Biometrics, and Regulatory Affairs to support statistical and regulatory requirements.
• Provide ongoing medical oversight of trials, including safety monitoring and protocol amendments.
• Engage with investigators, advisors, and external experts to support strategy and trial execution.
• Provide clinical input into biomarker and safety strategies and lifecycle planning.

Skills

Leadership

Strategic thinking

Regulatory submissions

Global development

Cross-functional collaboration

Clinical development leadership

Decision making

Education

MD

Board certification

Job description

Protego Biopharma, Inc. seeks a Senior Director/Executive Director, Clinical Development to provide strategic leadership for the lead AL amyloidosis program.

The role demands an experienced physician-leader with a track record of Phase 2/3 and registration studies in a fast-moving biotech setting. You will align clinical strategy with regulatory expectations, oversee registration-quality trials globally, and collaborate across Clinical Ops, Biometrics, and Regulatory Affairs to ensure data