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Senior Director, Global Clinical Project Management - Oncology

SystImmune · Princeton, NJ · 1 wk ago
On-siteInformation Technology$210k–$260k/yrFull-time

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, 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 discovery or IND-enabling stages, representing cutting-edge biologics development.

About the Role

The Senior Global Director, Clinical Project Management (CPM) 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 Senior Global Director will play a critical role in delivering high-quality data and ensuring the success of clinical studies.

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

Requirements

  • Bachelor’s degree in Life Sciences, Nursing, or a related field
  • Minimum of 15 years of experience in Clinical Trial Management, including demonstrated people leadership and direct line management experience
  • 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

Qualifications

  • 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 (hybrid, 3 days in office). Overnight travel approximately 25%.

Pay

The expected base salary range for this position is $210,000 - $260,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.

Benefits

  • 100% paid employee premiums for medical, dental, and vision
  • Short-term and long-term disability coverage
  • 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
  • 11 paid holidays

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