Senior Director, Oncology 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

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.