Executive Director, Clinical Development

SystImmune, Inc.; Princeton (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

SystImmune, Inc. is seeking an experienced clinical development leader to direct programs from design through data interpretation, supporting product development, regulatory submissions, and business strategy.

You will oversee trials, maintain data integrity, monitor safety with the Safety team, and collaborate cross-functionally to advance oncology biologics programs while ensuring GCP and regulatory compliance.

Qualifications

• MD or equivalent required; international degrees accepted.
• Minimum of 2 years in medical monitoring of oncology trials (phase 1/2); phase 3 experience preferred.
• Prior experience in clinical development or pharma/biotech settings; track record in safety oversight and trial execution.

Responsibilities

• Lead the design and implementation of clinical development programs grounded in medical and scientific principles, regulatory knowledge, and business objectives.
• Oversee execution and integrity of clinical trials; manage enrollment timelines and safety reporting with SAE coordination.
• Develop and ensure accuracy of key clinical documents (protocols, Investigator Brochures, CSRs, regulatory submissions).
• Serve as medical lead on study teams; align medical strategy across functions and participate in regulatory interactions; ensure GCP and pharmacovigilance compliance.

Skills

Medical monitoring

Clinical development

Regulatory knowledge

GCP compliance

Pharmacovigilance

Biologics expertise

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.