Global Director, Clinical Project Management

SystImmune, Inc.; Princeton (NJ); Hybrid; USD 180,000 - 230,000; Full time

Benefits offered by this job

Health insurance

STD

LTD

401(k) match

5-year vesting

15 PTO days

11 holidays

Job summary

SystImmune is seeking a Global Director, Clinical Project Management (CPM) to lead and coordinate global trials from initiation through completion. You will ensure GCP/regulatory compliance, manage study timelines and budgets, and foster cross-functional stakeholder communication.

Based in Princeton, NJ with onsite hybrid work arrangements. You will oversee regional CPMs, CRAs, and CTAs, drive protocol execution, risk mitigation, and regulatory document submission to support oncology programs

Qualifications

• Bachelor's degree in Life Sciences, Nursing, or a related field.
• Minimum of 10 years in clinical trial management, including 5 years in direct line management.
• 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
• Master's degree in a related field or clinical research certification (ACRP or SOCRA).
• Experience with electronic data capture (EDC) systems and clinical trial management software.
• Prior experience in running or supporting Oncology clinical trials a plus.
• Previous experience in a sponsor or CRO environment.

Responsibilities

• Oversee the planning and execution of global clinical trials
• Develop and implement study protocols, timelines, and budgets.
• Manage all aspects of clinical trial operations, including site selection, initiation, monitoring, and closeout.
• Ensure compliance with Good Clinical Practice (GCP) and regulatory guidelines.
• Coordinate with cross-functional teams, including investigators, vendors, and regulatory bodies.
• Monitor trial progress and manage data collection to ensure accuracy and integrity.
• Identify and mitigate project risks
• Oversee a team of regional CPMs, CRAs and CTAs.
• Ensure the preparation and submission of regulatory documents are compliant with local regulatory standards and maintained per good clinical practice.
• Conduct regular meetings with study teams and provide updates to stakeholders.
• Coordinate with external vendors and partners involved in the trial
• Support development of key process initiatives and SOPs internally
• Oversee vendors supporting trial execution

Skills

Leadership of cross-functional teams

Regulatory knowledge (GCP)

Communication skills

Organizational and project management

Multitasking / prioritization

Team leadership experience

Education

Bachelor's degree in Life Sciences or related field

Master's degree or clinical research certification (ACRP/SOCRA)

Tools

EDC systems

Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.

We are seeking a highly skilled and motivated Global Director, Clinical Project Management (CPM) to join our dynamic team. The successful candidate will oversee and coordinate global clinical trials from initiation through to completion. This role involves ensuring compliance with regulatory requirements, managing study timelines and budgets, and fostering effective communication among stakeholders. The global Director, Clinical Project Management will play a critical role in delivering high-quality data and ensuring the success of clinical studies.

This position requires onsite hybrid work model in Princeton, NJ.

Responsibilities

• Oversee the planning and execution of global clinical trials
• Develop and implement study protocols, timelines, and budgets.
• Manage all aspects of clinical trial operations, including site selection, initiation, monitoring, and closeout.
• Ensure compliance with Good Clinical Practice (GCP) and regulatory guidelines.
• Coordinate with cross-functional teams, including investigators, vendors, and regulatory bodies.
• Monitor trial progress and manage data collection to ensure accuracy and integrity.
• Identify and mitigate project risks
• Oversee a team of regional CPMs, CRAs and CTAs.
• Ensure the preparation and submission of regulatory documents are compliant with local regulatory standards and maintained per good clinical practice.
• Conduct regular meetings with study teams and provide updates to stakeholders.
• Coordinate with external vendors and partners involved in the trial
• Support development of key process initiatives and SOPs internally
• Oversee vendors supporting trial execution

Qualifications

• Bachelor's degree in Life Sciences, Nursing, or a related field.
• Minimum of 10 years of experience in clinical trial management, 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 in a related field or clinical research certification (e.g., ACRP or SOCRA).
• Experience with electronic data capture (EDC) systems and clinical trial management software.
• Prior experience in running or supporting Oncology clinical trials a plus.
• Previous experience in a sponsor or CRO environment.

Location/Travel

• Princeton NJ onsite in office
• Overnight travel ~25%

Compensation And Benefits

The expected base salary range for this position is $180,000 - $230,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.

SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.