Executive Director, Clinical Development - Oncology

SystImmune; Princeton (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

SystImmune in Princeton, NJ is seeking a medical professional to lead clinical development programs in oncology. MD or equivalent required with experience in medical monitoring of early-phase trials and oversight of safety.

You will drive the design of protocols and reports, coordinate with Clinical Operations and Regulatory affairs, ensure GCP compliance, and communicate medical strategy across study teams and with investigators.

Qualifications

• MD 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. xzgxqkn

Responsibilities

• Lead design and implementation of clinical development programs.
• Collaborate across functions to meet regulatory submissions and strategy.
• Oversee execution and integrity of clinical trials and enrollment progress.
• Ensure SAE reporting and safety monitoring in coordination with Safety team.
• Provide medical input across product lifecycle from early development through phase 3.
• Represent medical strategy in regulatory interactions and ensure GCP compliance.

Skills

Medical monitoring

Clinical development

GCP knowledge

Pharmacovigilance

Safety data interpretation

Education

MD or equivalent

Job description

Job Description:

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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. xzgxqkn

Sound medical judgment with expertise in medical safety data interpretation.