Sr. Director, Clinical Development (MD)

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

Job Summary

The Senior Director or Executive Director, Clinical Development will provide strategic leadership for the lead program in light chain (AL) amyloidosis, ensuring regulatory alignment and cross-functional collaboration to advance clinical assets in support of company’s objectives. This role requires an experienced physician-leader with proven success leading Phase 2/3 and registration studies, who brings well-established development best practices and global clinical experience while thriving in a fast-moving biotech environment.

Duties/Responsibilities

• Define and drive the clinical development strategy for the lead program in AL amyloidosis.


• Translate scientific, translational, and clinical data into clear development plans, milestone decisions, and risk-benefit assessments.


• Ensure alignment of clinical strategy with regulatory expectations, target product profiles, and long-term portfolio objectives.


• Lead the design and oversight and registration-quality clinical trials, including endpoint selection, patient population strategy, and global development considerations.


• Provide senior clinical oversight to ensure trials meet registration standards for quality, safety, and data integrity.


• Partner with Clinical Operations, Biometrics and Regulatory Affairs to ensure clinical strategy supports statistical and regulatory requirements.


• Provide ongoing medical oversight of clinical trials, including safety monitoring, emerging data review, and protocol amendments.


• Partner closely with Clinical Operations on trial feasibility, site strategy, enrollment planning, and CRO oversight.


• Review and interpret clinical data to guide program adjustments and development decisions.


• Ensure clinical readiness for audits, inspections, and regulatory review.


• Represent Clinical Development in health authority interactions.


• Provide clinical leadership for briefing documents, responses to regulatory questions, and clinical components of submissions.


• Engage with investigators, advisors, and external experts to support product development strategy and clinical trial execution.


• Provide clinical input into biomarker strategy, safety strategy, and future lifecycle planning.

Requirements

• MD required; Board certification preferred.


• 8+ years of clinical development experience in biotechnology and/or pharmaceutical organizations or similar positions within clinical research organizations.


• Proven leadership of late-stage and registration-enabling clinical trials, including global studies.


• Direct involvement in regulatory submissions (e.g., NDA, BLA, MAA) and health authority interactions.


• Experience leading programs through key inflection points (e.g., pivotal study initiation, registration readiness).


• Strong strategic thinking with the ability to integrate clinical, regulatory, and scientific perspectives.


• Deep understanding of global clinical development and registration pathways.


• Sound clinical judgment and risk-benefit decision-making capability.


• Clear and credible communicator with regulators, investigators, executives, and cross-functional teams.


• Sets a high standard for clinical excellence, patient safety, and data integrity.


• Operates effectively in ambiguity while driving disciplined execution.


• Models transparency, collaboration, and patient-centric decision-making

Base Salary

$260,000 - $350,000. Exact compensation may vary based on skills and experience.

In addition to a competitive base salary, we offer stock options, and a target bonus. Protego also provides a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, and supplemental disability insurance.

Equal Opportunity Employer

Protego Biopharma is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.