Senior Global Clinical Trial Manager - Princeton, United States - Genmab A/S

Description

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 & DepartmentAs Senior Global Clinical Trial Manager (GCTM) in Clinical Operations at Genmab, you will be part of the Trial Management team, currently more than 75 highly motivated and experienced people located in Denmark, the United States, the Netherlands, and Japan.

As Senior GCTM, you will:

Lead one or more trials ensuring that key project deliverables are met with the overall goal of developing new and innovative treatments for cancer.

Lead the cross-functional trial-specific trial team, including the CROs, to deliver clinical trials within budget and timelines and according to quality standards defined by regulations, Genmab SOPs and ICH-GCP.We a looking for someone driven by ensuring a ONE Team culture with CROs 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.

Working in Clinical Operations is exciting, 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 training courses and tasks, get settled with our IT systems, and that you team up with your mentor, colleagues, and relevant stakeholders.

Key responsibilities:
The Senior GCTM will plan, set up and execute clinical trials and will be responsible for successful delivery of key trial management elements


The principal responsibilities are:
Lead the trial team and act as the overall responsible for trial related activities from startup. to reporting of a clinical trial in close collaboration with internal stakeholders and CROs.
Secure trial deliverables in a proactive and motivational manner.
Communicate with and perform stakeholder management of CROs and other stakeholders throughout all stages of trial conduct.
Create a good working environment by being a role model in great teamwork.
Ensure proper documentation, record management, risk assessment/management, trial budgets as well as sponsor engagement and sponsor oversight activities.
Constantly develop and implement new and better clinical trial practices.
Act as Clinical Operations representative in Compound Development Teams.

Trial Leadership and ManagementLead the Clinical Trial Team (CTT).Define and manage CTT goals (together with CTT).Review and approve protocol and amendment changes.

Review Master ICF.Approve operational plans, manuals, and charters for the trial.
Oversee vendor selection process.
Initiate and ensure the accuracy and completeness of initial Work Order (WO) / Change Orders (CO).Drive country selection process.
Coordinate and respond to IEC/IRB comments.
Overview of major PDs and PD trending.
Approve data cleaning plans.
Work closely with CPL as needed for CST/CDT deliverables.
Review and contribute to CSR as needed.
Execute operational strategy related to drug supply.
Execute regulatory submission strategy.


Budget and Planning:
Assist in initial development and manage trial budget.

Plan, implement & ensure maintenance of detailed integrated trial timelines from study outline though CSR.Develop and execute recruitment projections and strategy.

Risk Management:
Conduct study risks identification with CTT & risks management activities.
Oversee CTT issue log and issue resolution.
Oversee CTT Action/Decision logs are maintained.
Assist in preparation for & responses to audits.
Ensure CAPAs are in place, if applicable.
Key CompetenciesDemonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence.
Experience in leading & managing global teams.
Experience in mentoring CTMs and CTAs.
Planning and budget management skills.
Outsourcing and vendor management experience.
Ability to anticipate risks and issues with proactivity to offer solutions & to timely escalate issues when needed.
Ability to foster a "One Team" spirit, inclusive mindset.
Confidence to challenging status-quo thinking and behaviour; can work with agility and an innovative mindset.
Ability to align with Corporate, Development Operations, Trial Management, and CDT goals,Oncology experience strongly preferred.

Requirements - what you must haveA Bachelor or Master of Science level degree within the medical, biological, pharmaceutical science, or equivalent area(s).Minimum 10 years of experience in global clinical trial management roles from pharmaceutical companies and/or CROs.

Experience within the field of Oncology is strongly preferred.
Early development / first-in-human trials is strongly preferred.
Proven skills from working in a project oriented and international organization.

Minimum 2 years of experience as Clinical Operations representative in Clinical Development Teams (CDTs) or Global Project Teams (GPTs) strongly preferred.

Excellent communication skills in English, both written and spoken.

Moreover, you meet the following personal requirements:
Dedicated team player who enjoys leading teams and inspiring trust among colleagues.
Quality mindset and able to prioritize your work in a fast paced and changing environment.
Result- and goal-orientation and committed to contributing to the overall success of Genmab.

Where you will workThis role is based in Genmab's office in Princeton, NJ USA; Copenhagen, Denmark; or Utrecht, the Netherlands, and is hybrid.

For US based candidates, the proposed salary band for this position is as follows:
$114,375.00$190,625.00The 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 YouYou are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatmentYou bring rigor and excellence to all that you do.

You are a fierce believer in our rooted-in-science approach to problem-solvingYou are a generous collaborator who can work in teams with diverse backgroundsYou are determined to do and be your best and take pride in enabling the best work of others on the teamYou are not afraid to grapple with the unknown and be innovativeYou 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 soLocationsGenmab 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 GenmabFounded 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 inclusionWe 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 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.