Executive Director, Clinical Development - Oncology

SystImmune; Princeton (NJ); On-site; USD 210,000 - 260,000; Full time

Job summary

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.

Lead the design and implementation of programs grounded in medical principles and regulatory knowledge, while ensuring GCP and safety standards. MD-level expertise with oncology trial experience is required.

Qualifications

• M.D. or equivalent degree (international degrees accepted).
• Minimum 2 years medical monitoring experience in oncology trials (Phase 1/2).
• Experience in clinical development or biotech/pharma settings.
• Proven track record in safety oversight for biologics such as ADCs and IO agents.
• Strong understanding of drug development processes.
• Ability to interpret safety data and provide medical judgment.

Responsibilities

• Lead the design and implementation of clinical development programs grounded in sound medical and scientific principles, regulatory knowledge, and business objectives.
• Oversee the execution and integrity of clinical trials. Collaborate with Clinical Operations to manage enrollment progress, timeline adherence, and delivery of key milestones.
• 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. Engage with investigators and opinion leaders to inform development strategy and protocol design.

Skills

Medical monitoring

Oncology trials

Regulatory knowledge

Clinical strategy

Pharmacovigilance

GCP compliance

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.