Global Director, Clinical Project Management
Listed on 2026-07-23
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Research/Development
Regulatory Compliance Specialist, Clinical Research
Syst Immune is a leading clinical‑stage biopharmaceutical company headquartered in Redmond, Washington and Princeton, New Jersey. The company focuses on developing innovative cancer therapies, including bi‑specific, multi‑specific antibodies and antibody‑drug conjugates, with multiple assets in clinical trials for solid tumors and hematologic indications.
PositionGlobal Director, Clinical Project Management (CPM) – responsible for overseeing and coordinating global clinical trials from initiation through completion, ensuring regulatory compliance, managing timelines and budgets, and fostering communication among stakeholders.
Responsibilities- Plan and execute global clinical trials, including study protocol development, timelines, and budgets.
- Manage all aspects of clinical trial operations: site selection, initiation, monitoring, closeout.
- Ensure compliance with Good Clinical Practice (GCP) and regulatory guidelines.
- Coordinate with cross‑functional teams, investigators, vendors, and regulatory bodies.
- Monitor trial progress, manage data collection, and ensure accuracy and integrity.
- Identify and mitigate project risks.
- Oversee a team of regional CPMs, CRAs, and CTAs.
- Prepare and submit regulatory documents in compliance with local regulatory standards.
- Conduct regular meetings with study teams and provide updates to stakeholders.
- Coordinate with external vendors and partners involved in the trial.
- Develop and implement process initiatives and SOPs internally.
- Support vendors that facilitate trial execution.
- Bachelor’s degree in Life Sciences, Nursing, or a related field.
- Minimum 10 years of clinical trial management experience, including at least 5 years in a direct line‑management role.
- Strong understanding of GCP and regulatory requirements.
- Excellent organizational and project‑management skills.
- Proven ability to lead cross‑functional teams and manage multiple priorities.
- Strong communication and interpersonal skills.
- Ability to work collaboratively in a team‑oriented environment.
- Flexibility and adaptability to changing priorities and workload.
- Master’s degree or clinical research certification (e.g., ACRP, SOCRA) is preferred.
- Experience with electronic data capture (EDC) systems and clinical trial management software.
- Prior experience in oncology clinical trials is a plus.
- Previous experience in a sponsor or CRO environment.
- Onsite in Princeton, New Jersey (hybrid model).
- Overnight travel approximately 25%.
Base salary range: $180,000 – $230,000 annually. Compensation is based on qualifications, experience, and skills.
Benefits include 100% paid employee medical, dental, and vision premiums; STD and LTD; a 401(k) plan with a 50% company match up to 3% and a vesting schedule of five years; 15 paid time off days per year; sick leave; 11 paid holidays; and additional benefits.
Equal Opportunity EmployerSyst Immune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
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