Global Director, Clinical Project Management

Clinical Operations - Princeton NJ - Full Time

The company 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). The company has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. The company 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 companys 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

• Bachelors 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

• Masters 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 $180000 - $230000 annually. Actual compensation will be based on a variety of factors including but not limited to a candidates qualifications experience and skills.