Director, Clinical Project Lead

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role & Department
Are you looking for an opportunity where you can take the lead in the operational strategy and oversight of oncology clinical trials and ensure appropriate communication to relevant stakeholders? We are looking for a Clinical Project Lead (CPL) driven by ensuring a one-team culture and who excels in contributing to great teamwork and working environment. Join our innovative, hardworking, and ambitious team collaborating in a high performing and high pace environment to improve the lives of cancer patients.
The Clinical Project Lead is responsible for the operational strategy and oversight of one or more trials within one or more development projects. The Clinical Project Lead will join Clinical Operations with team members in Denmark, US, the Netherlands, and Japan. The Clinical Project Lead represents Clinical Operations in one or more cross-functional Compound Development Teams (CDT) and will represent one or more functional areas within the department.
Key Responsibilities
As Clinical Project Lead, you will:

• Take the lead in oversight of trial budget across trials and work with the CMT to ensure timely deliverables of trials in accordance with the company objectives
• Ensure close and transparent communication between the CDT and the Clinical Management Team (CMT)
• Support vendor selection, work order review and budget development at trial level
• Provide input to the Clinical and Compound Development Plans developed by the CDT
• Support the Clinical Trial Managers (CTMs) in ensuring that the overall deliverables of the trials support the overall development strategy and timelines and within agreed budget and quality standards defined by regulations, Genmab SOPs and ICH-GCP
• Drive lessons learned across trials/projects and vendors, review major findings, and ensure proper follow up
• Support the synopsis development, protocol development, document generation for Health Authorities (HA) and respond to questions from HA (as applicable), attend Key Opinion Leader (KOL)/partner meetings, give input to the overall project objectives
• Ensure high-level communication on progress of trial deliverables and timelines to relevant stakeholders in the CDT as well as external partners as applicable and responsible for ensuring

The employee will also give input to the department related activities, the overall department strategy and lead/support various initiatives/activities internally within the department or across departments.
The CPL may also:

• Act as deputy for the HoD, Clinical Operations in the Protocol Review Committee, Safety Committees, and Steering Committees with the vendors
• Represent Clinical Operations in Project Boards, Global Development Team, and Operational Committee’s/Steering Committee’s with the partners
• Act as CTM, if no other CTM or a less experienced CTM is assigned to a trial as CTM, the CPL will be responsible for planning, set-up and conduct of clinical trials in accordance with Genmab SOPs

Working in Clinical Operations is exciting, intense, challenging, and fun at the same time. The dedication, collaborative and knock-your-socks-off spirit of our employees are what really shapes our team. From Day One, the onboarding program makes sure that you accomplish relevant trainings, get settled with our IT systems and that you team up with your mentor, colleagues, and relevant stakeholders.
Requirements – What You Must Have

• Minimum 2 years’ experience as Clinical Operations representative in Clinical Development Teams (CDTs) or Global Project Teams (GPTs) would be preferable
• Significant experience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teams
• Minimum requirement of 12 or more years of experience in clinical operations
• Experience within the field of oncology and/or first-in-human trials is preferred
• Proven performance in earlier role/comparable role
• Experience with operational management and budget planning
• Bachelor of science degree with relevant specialization; Master of science degree preferred
• Significant experience in leading and managing complex clinical projects/programs
• Excellent communication skills in English, both written and spoken
• Global clinical program level experience required
• Experience in the role as an informal leader
• Proven skills from working in a project oriented and international organization

Moreover, you meet the following personal requirements:

• Quality mindset and able to prioritize your work in a fast paced and changing environment
• Dedicated team player who enjoys leading teams and inspire trust among colleagues
• Result- and goal-oriented and committed to contributing to the overall success of Genmab

About You - additional qualities you bring to the table

• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are a generous collaborator who can work in teams with diverse backgrounds
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted in science approach to problem-solving
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You are not afraid to grapple with the unknown and be innovative
• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You work hard and are not afraid to have a little fun while you do so

Where you will work
This role can be located in Plainsboro, NJ USA; Copenhagen, Denmark; or Utrect, the Netherlands and will report to the office.
For US based candidates, the proposed salary band for this position is as follows:
$170,625.00---$284,375.00
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.
About You

• 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
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are not afraid to grapple with the unknown and be innovative

Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.
When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
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 https://www.genmab.com/privacy.
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.