Associate Director Global Clinical Trial Manager

Genmab A/S; Princeton (NJ); Hybrid; USD 148,000 - 223,000; Full time

Job summary

An established industry player is seeking a Global Clinical Trial Manager to lead a dynamic team in the pursuit of innovative cancer treatments. This role is pivotal in managing clinical trials, ensuring operational excellence, and fostering a collaborative environment. With a strong emphasis on leadership and strategic thinking, you will play a key role in guiding your team towards achieving project goals while maintaining high standards of quality and compliance. If you are passionate about making a difference in the lives of patients and thrive in a fast-paced environment, this opportunity is perfect for you.

Benefits

Health Insurance

Retirement Plan

Flexible Working Hours

Professional Development

Remote Work Options

Qualifications

• 12+ years of experience in clinical operations.
• Experience managing complex global clinical projects.
• Strong focus on people management and team leadership.

Responsibilities

• Lead and manage a team of Clinical Trial Managers and Associates.
• Support trial deliverables and ensure team success.
• Engage with stakeholders to drive project alignment.

Skills

Leadership

Stakeholder Management

Clinical Operations

Budget Planning

Strategic Thinking

Communication Skills

Education

Bachelor of Science

Master of Science

Job description

At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

Overview

The Global Clinical Trial Manager, Team Manager (GCTM-TM) is responsible for line management of approximately 12 direct reports, including Clinical Trial Managers (CTMs) and Clinical Trial Associates (CTAs), for larger programs or trials. This role provides operational and strategic support across trials as needed and may assume Global Clinical Trial Manager (GCTM) responsibilities to address fluctuating demands throughout the trial lifecycle.

Roles & Responsibilities

Leadership:

• Provide line management for CTMs and CTAs across trials within a program, ensuring performance and competency development.

• Collaborate with Global Clinical Trial Managers (GCTMs) on trial activities for assigned direct reports.

• Support trial deliverables by facilitating progress, coaching, and mentoring CTMs and CTAs.

• Advise on resource needs and team performance to support overall program resource planning.

• Ensure team success through setting clear expectations, guiding performance, and leading competency development.

• Lead functional working groups; serve as process owner or Subject Matter Expert (SME) within Clinical Operations.

• Support training initiatives across Trial Operations as needed.

Trial support:

• Take on GCTM tasks when necessary to support trial execution, including setup of new protocol amendments, ad hoc data cuts, or temporary coverage.

• Provide strategic support for Project Lead activities, including contract and amendment reviews, country/site strategy, and vendor management.

• Lead cross-trial initiatives as needed, such as implementation of Corrective and Preventive Actions (CAPAs) or new process rollouts across the program.

Competencies

• Proven leadership experience with a strong focus on people management.

• Skilled in setting clear expectations, coaching, and mentoring direct reports.

• Effective collaborator and relationship builder with strong stakeholder management skills.

• Demonstrates a collaborative mindset.

• Understanding of trial objectives and study goals for trials managed by direct reports.

• Comprehensive knowledge of trial execution and clinical drug development.

• In-depth understanding of Good Clinical Practice (GCP) standards.

• Therapeutic area experience preferred

Requirements – what you must have

• Bachelor of science degree with relevant specialization; Master of science degree preferred

• Minimum requirement of 12 or more yearsof experience in clinical operations

• Significant experience in leading and managing complex global clinical projects/programs

• Significant experience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teams

• Experience with operational management and budget planning

• Proven performance in earlier role/comparable role

• Global clinical program level experience required

• Experience within the field of oncologyis preferred

• Minimum 2 years’ experience as Clinical Operations representative in Clinical Development Teams (CDTs) or Global Project Teams (GPTs) would be preferable

• Experience leading team members in global matrix environment, leveraging tools and technology to ensure business needs are met.

• Strategic thinking with ability to optimize organizational resources for successful program execution

• Excellent communication skills in English, both written and spoken

Moreover, you meet the following personal requirements:

• Dedicated team player who enjoys leading teams and inspire trust among colleagues

• Quality mindset and able to prioritize your work in a fast paced and changing environment

• Result- and goal-oriented and committed to contributing to the overall success of Genmab

Additional Job Description

Inform overall strategy and the synopsis development in the CDT through cross-functional teams within clinical operations

Proactively engage with internal and external stakeholders (e.g. CTMs, cross-functional teams, project board, CRO project directors, KOLs, partners) to drive alignment towards project goals
Participate development, monitoring, review, and update of trial/project budgets in collaboration with HoDs and CTMs
Drive systems for timely documentation as well as compliance with regulations, SOPs, ICH/GCP, and Code of Business Ethics
Guide systemic improvements based on learnings across trials and projects
Oversee and participate in activities related to audits and inspections, as well as follow-up on findings within own projects
Lead and participate in cross-functional working groups/projects/task forces
Collaborate with external partners/industry peers and scan the landscape for exploration and adoption of cutting-edge methods to address internal challenges/needs
Train and mentor teams on emerging clinical trial best practices

For US based candidates, the proposed salary band for this position is as follows:

$148,320.00---$222,480.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

Regular full-time U.S. employees are eligible to enroll in Genmab benefits. Our benefits package is crafted to help employees feel supported and cared for in all aspects of life — physical, financial, social, and emotional.

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

• You have experience working in a fast-growing, dynamic company (or a strong desire to)

• You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.