Clinical Lead - Cell & Gene Therapy

IQVIA•Durham, NC

1d•Remote

About The Position

We are looking for a Clinical Lead to join our innovative and dynamic group of global professionals dedicated to assisting Gilead in driving healthcare forward. This is an important and high-profile role within our Research & Development Solutions organization to enable medical breakthroughs that advance healthcare and patient treatment options around the world. The Clinical Lead role requires you to lead the clinical team, leveraging your clinical operations and therapeutic expertise to achieve the delivery of the project’s overall objectives to Gilead’s satisfaction. You will be supported by domain experts in every function, enabled by best-in-class technology and data analytics. Key collaborations with Project Lead, Global Site Activation Lead will support cohesive delivery along with overarching coordination and financial analysis. This is a vital role within our organization and IQVIA’s size and global footprint will present you with the breadth of opportunities necessary to develop your career. Typically assigned to one or two projects or a development program within a therapeutic area, responsibilities might include: Leading Global Clinical team, accountable for achievement of milestones and quality of contracted scope. Monitoring clinical progress and serving as clinical project contact with Gilead as the customer. Developing clinical operations plans and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures. Training and providing guidance to CRAs/Clinical team and advising on critical specific study issues – overseeing monitoring that will yield high data quality and integrity. Collaborating with other functional groups to support milestone achievement and manage study issues and obstacles Ensuring all appropriate recruitment strategies are in place to maximize recruitment opportunities including all outreach or digital offerings. Anticipating risk and implementing mitigation strategies Managing study team assignments, accountability and resource requirements Overseeing the scope of clinical delivery as per budget and contract. Identifying changes in scope and supporting the project leader in ensuring the financial success of the project. Participate in Bid Defenses and pre-award activities.

Requirements

Bachelor's degree in health care or other scientific discipline with 7 years clinical research/monitoring experience
Clinical project management experience within the drug development industry, with previous CRO experience preferred.
Minimum 4 years prior clinical management/operations experience; or equivalent combination of education, training and experience
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
Strong presentation and organizational skills.
Experience in cell & gene therapy and CAR-T oncology studies.
Work independently, this is a home-based position.

Responsibilities

Leading Global Clinical team, accountable for achievement of milestones and quality of contracted scope.
Monitoring clinical progress and serving as clinical project contact with Gilead as the customer.
Developing clinical operations plans and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures.
Training and providing guidance to CRAs/Clinical team and advising on critical specific study issues – overseeing monitoring that will yield high data quality and integrity.
Collaborating with other functional groups to support milestone achievement and manage study issues and obstacles
Ensuring all appropriate recruitment strategies are in place to maximize recruitment opportunities including all outreach or digital offerings.
Anticipating risk and implementing mitigation strategies
Managing study team assignments, accountability and resource requirements
Overseeing the scope of clinical delivery as per budget and contract.
Identifying changes in scope and supporting the project leader in ensuring the financial success of the project.
Participate in Bid Defenses and pre-award activities.