Associate Director, Clinical Project Management - Oncology

Systimmune

Princeton (NJ)

Hybrid

USD 150,000 - 180,000

Full time

48 hours ago
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Benefits offered by this job

Premium medical/dental/vision coverage
401(k) with company match
Paid time off (PTO)

Job summary

SystImmune in Princeton, NJ, seeks an Associate Director, Clinical Project Management to oversee global clinical trials from initiation to completion. You will ensure regulatory compliance, manage study timelines and budgets, and foster cross‑functional collaboration among investigators, vendors, and regulatory bodies.

The role requires leading a team of CPMs, CRAs, and CTAs, with a strong background in oncology trials and GCP knowledge.

Qualifications

  • Bachelor’s degree in Life Sciences, Nursing, or related field.
  • 7+ years in clinical trial management; preference for leading Clinical Operations teams (CRA, SSU, CTM).
  • Experience in managing global oncology trials and in sponsor or CRO environments.
  • Strong knowledge of GCP and regulatory requirements.
  • Excellent organizational and project management skills; ability to lead cross-functional teams.
  • Effective communication and interpersonal skills; able to manage multiple priorities.
  • Master’s degree or clinical research certification (ACRP or SOCRA) preferred; experience with EDC and CTMS tools.

Responsibilities

  • Oversee planning and execution of global clinical trials.
  • Develop protocols, timelines, and budgets; manage trial operations from initiation to closeout.
  • Ensure GCP compliance and regulatory alignment across sites.
  • Coordinate with investigators, vendors, and regulatory bodies; manage data integrity.
  • Lead regional CPMs, CRAs, and CTAs; mentor teams.
  • Prepare and submit regulatory documents in line with local standards.

Skills

Project management
Cross-functional leadership
Regulatory compliance
GCP knowledge
Stakeholder communication
Team leadership

Education

Bachelor's degree in Life Sciences, Nursing, or related field
Master’s degree or clinical research certification (ACRP or SOCRA)

Tools

Electronic Data Capture (EDC) systems
Clinical Trial Management Software
CTMS

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 Associate 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 Associate 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 7 years of experience in clinical trial management with a preference of leading Clinical Operations team (CRA, SSU, CTM).
  • Experience in managing global oncology trials
  • 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 $150,000- $180,000 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.

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