Senior Director, Clinical Operations

Are you ready to uplevel your career and join an innovative biopharmaceutical company and participate in our exciting journey?

We are looking for a Senior Director, Clinical Operations, to join our Radiopharma Team.

Working with Us

At Y-mAbs Therapeutics, our mission is to become the world leader in developing better and safer radioimmunotherapy and antibody-based oncology products addressing clear unmet pediatric and adult medical needs. With the right partnerships and collaborations, we envision changing the course of cancer treatment and improving outcomes for patients and their families.

We have offices in Princeton, New Jersey(US ) and Hørsholm, Denmark (near Copenhagen). We also have a laboratory based in Nutley, New Jersey .

Y-mAbs has a very exciting future ahead. If you are passionate about being a part of a truly patient-centric organization focused on developing and commercializing cutting-edge therapies to treat a variety of cancers, we want you!

About the Role

The Senior Director, Clinical Operations, Radiopharma BU serves as the lead for Clinical Operations within the Radiopharma Business Unit and is responsible for leadership, oversight, and execution of US-based clinical programs (diagnostic and therapeutic), with potential for global expansion. In this role, this person will head a team of clinical operations professionals and external vendors ensuring that clinical studies are managed in alignment with Y-mAbs’ overall corporate goals, timelines, budgets, and quality / regulatory expectations.

This role, within a quality-focused organization, requires expertise in clinical operations, project management, vendor management, continuous process improvement, and scientific collaboration, with a focus on ensuring the successful execution of clinical trials, optimal trial delivery, and maintaining a strong sponsor-CRO-site relationship. This role may include supervision of Clinical Trial Manager(s), Clinical Trial Associate(s), Clinical Research Associate(s).

This position is part of the Radiopharma Business Unit and is located in the US.

Key Responsibilities

Clinical Trial Oversight : Lead clinical operations planning and execution and provide technical guidance and oversight to ensure successful translation of corporate strategy into actionable, efficient operational plans. Determine the appropriate mixture and utilization of internal vs. external clinical operational resources. Develop and oversee comprehensive study budgets across all vendors and programs, including comprehensive financial forecasting, invoice reconciliation, and tracking to support corporate financial planning.

Collaboration & Communication : Work with various in-house functional groups and external advisors with regards to clinical study operational aspects including safety reporting and processing, study drug supply plans, cross-functional communication / interaction plans and monitoring. Lead key opinion leader (KOL) relationships at clinical trial sites.

Project Management & Oversight : Establish and leverage performance metrics to monitor conduct adherence to the protocol, regulations, timelines, and budget. This includes reviewing site recruitment, initiation and patient enrollment progress, and reviewing / acting on trending reports. Monitor and analyze key performance indicators (KPI’s) and metrics, taking proactive measures to address any issues or challenges.

Vendor & CRO Management : Develop and lead requests for proposals (RFP) to ensure alignment of service requirements and metrics and establish a strong budget foundation during the selection of external vendors including, but not limited to, those providing CRO, laboratory, IP supply, and distribution services.

Clinical Trial Documentation & Reporting : Apply working knowledge of competitive regulatory and clinical industry best practices including GCP, FDA, and ICH Guidelines to ensure all clinical programs are planned and executed compliantly.

Site Relationship Management : Manage clinical trial implementation with clinical sites, external consultants, and CRO vendors to ensure timely implementation of clinical studies.

Team Development & Training : Recruit, hire, direct, manage and ensure collaboration within a team of clinical operational professionals in the planning, execution, and governance of projects / portfolios.

Continuous Improvement & Best Practices : Stay abreast of industry trends, emerging technologies, and regulatory changes in the clinical arena, providing strategic recommendations to enhance capabilities and competitive advantage. Ensure project leadership personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans, and all regulatory requirements. Oversee all applicable clinical trial documentation updates (continuous process improvement).

Quality Assurance & Regulatory Affairs : Ensure studies adhere to applicable regulations and the Quality Management System.

Key Competencies & Requirements

Education & Experience : MSc or PhD (preferred) in Medical, Biological, Pharmaceutical Sciences, or equivalent. Minimum 10 years of experience (5 years in leadership) with clinical trials within the pharmaceutical or biotechnology industry or equivalent experience. Minimum 3 years of management experience in clinical research. Radiopharmaceutical clinical trial experience required.

Expertise : Extensive knowledge of clinical trial operations, GCP, regulatory requirements, and clinical trial management. Experience with cross-functional teams.

Skills : Strong project management skills with an entrepreneurial mindset; ability to prioritize and work effectively in a dynamic, fast-paced environment. Proficiency with clinical trial management systems (CTMS), eTMF, and other relevant clinical research technologies. Exceptional communication, interpersonal, and leadership skills. Ability to influence and build strong relationships with internal and external stakeholders. Strong analytical and problem-solving skills with a data-drive and results-oriented approach. Strong commitment to and experience in continuous improvement. Demonstrated commitment to quality, compliance, and patient safety in all aspects of clinical operations.

Attributes : High degree of initiative, proactivity, and flexibility to adjust to evolving clinical trial needs. Willingness and ability to mentor and develop junior team members. The ability to thrive in an organization that values innovation, adaptability, and a commitment to delivering meaningful results for patients.

Desired Characteristics : Proven track record of managing complex, multi-site clinical trials. Ability to manage ambitious timelines and work effectively with cross-functional teams. Experience working with radiopharmaceutical clinical trials is a plus. Knowledge of industry trends, emerging clinical trial technologies, and innovative methodologies.

Travel : Up to 30%.

Why Join Us?

As part of our Clinical Operations team, you will have the opportunity to make a direct impact on the development of life-changing treatments for cancer patients. We offer a dynamic, fast-paced work environment where innovation, collaboration, and continuous improvement are at the forefront. You will be part of a passionate team committed to transforming the lives of patients and their families.

LOCATION

Preference is Princeton, New Jersey

Interested in Applying

If you find the above interesting, join Y-mAbs and become part of our team in a fast-moving environment that offers a unique combination of scientific insight, entrepreneurship, and exciting challenges.

Apply via LinkedIn

Y-mAbs Therapeutics is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

For more information, please see our web site regarding the company and our development projects.