Executive Director, Clinical Development

SystImmune; Princeton (NJ); On-site; USD 190,000 - 320,000; Full time

Job summary

SystImmune in Princeton, NJ seeks an experienced physician leader to direct clinical development programs across the product lifecycle, from early development to phase 3, including internal and partnered studies.

You will oversee trial execution, safety monitoring, and integrity, collaborating with Clinical Operations and the Safety team to meet milestones and SAE reporting requirements. Lead regulatory submissions and develop key clinical documents with rigorous scientific accuracy.

Qualifications

• Lead the design and implementation of clinical development programs grounded in sound medical and scientific principles, regulatory knowledge, and business objectives.
• Provide strategic medical input across the product lifecycle from early development through phase 3, for both internal and partnered programs.
• Oversee the execution and integrity of clinical trials. Collaborate with Clinical Operations to manage enrollment progress, timeline adherence, and delivery of key milestones. Proactively monitor trial safety in coordination with the Safety team, ensuring compliance with serious adverse event (SAE) reporting requirements.
• Drive the development and scientific accuracy of key clinical documents, including protocols, Investigator Brochures, Clinical Study Reports (CSRs), regulatory submissions, and response packages.
• Serve as the medical lead on clinical study teams , aligning medical strategy across functions. Act as a key clinical representative in regulatory interactions and ensure adherence to GCP, pharmacovigilance standards, SOPs, and global compliance requirements.
• Provide in-house clinical expertise on assigned compounds and indications. Actively engage with investigators and opinion leaders to inform development strategy and protocol design. Stay current on therapeutic area developments through continuous learning and participation in scientific forums.

Responsibilities

• Lead the design and implementation of clinical development programs grounded in sound medical and scientific principles, regulatory knowledge, and business objectives.
• Provide strategic medical input across the product lifecycle from early development through phase 3, for both internal and partnered programs.
• Oversee the execution and integrity of clinical trials. Collaborate with Clinical Operations to manage enrollment progress, timeline adherence, and delivery of key milestones. Proactively monitor trial safety in coordination with the Safety team, ensuring compliance with serious adverse event (SAE) reporting requirements.
• Drive the development and scientific accuracy of key clinical documents, including protocols, Investigator Brochures, Clinical Study Reports (CSRs), regulatory submissions, and response packages.
• Serve as the medical lead on clinical study teams , aligning medical strategy across functions. Act as a key clinical representative in regulatory interactions and ensure adherence to GCP, pharmacovigilance standards, SOPs, and global compliance requirements.
• Provide in-house clinical expertise on assigned compounds and indications. Actively engage with investigators and opinion leaders to inform development strategy and protocol design. Stay current on therapeutic area developments through continuous learning and participation in scientific forums.

Skills

Medical monitoring

Cross-functional collaboration

Regulatory submissions support

Education

MD or equivalent

Job description

Lead the direction, planning, execution, and interpretation of clinical trials within the Clinical Development program. Collaborate across functions to deliver high-quality clinical data that supports product development, regulatory submissions, and business strategy.

Job Summary

• Lead the design and implementation of clinical development programs grounded in sound medical and scientific principles, regulatory knowledge, and business objectives. Provide strategic medical input across the product lifecycle from early development through phase 3, for both internal and partnered programs.
• Oversee the execution and integrity of clinical trials. Collaborate with Clinical Operations to manage enrollment progress, timeline adherence, and delivery of key milestones. Proactively monitor trial safety in coordination with the Safety team, ensuring compliance with serious adverse event (SAE) reporting requirements.
• Drive the development and scientific accuracy of key clinical documents, including protocols, Investigator Brochures, Clinical Study Reports (CSRs), regulatory submissions, and response packages.
• Serve as the medical lead on clinical study teams , aligning medical strategy across functions. Act as a key clinical representative in regulatory interactions and ensure adherence to GCP, pharmacovigilance standards, SOPs, and global compliance requirements.
• Provide in-house clinical expertise on assigned compounds and indications. Actively engage with investigators and opinion leaders to inform development strategy and protocol design. Stay current on therapeutic area developments through continuous learning and participation in scientific forums.

Qualifications

• M.D. or equivalent (international degrees accepted).
• Minimum of 2 years of experience in medical monitoring of oncology clinical trials; phase 1/2 required, phase 3 experience preferred.
• Prior experience in clinical development or pharmaceutical/biotech settings.
• Proven track record in product safety oversight and clinical trial execution, particularly with biologics such as ADCs and immune-oncology agents.
• Strong foundation in clinical and drug development processes.
• Sound medical judgment with expertise in medical safety data interpretation.