Director, Team Lead, Trial Management

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 

In order to further strengthen Trial Management team, we are looking to recruit an enthusiastic and experienced candidate to the position of Director, Team Lead with Trial Management.

As Director, Team Lead, you will be accountable for all aspects of assigned clinical trials/programs spanning from early development to late development within Clinical Operations, as well as leading a larger team of highly competent and experienced employees (CTMs, SOLs and CTAs). We are particularly keen to find the right candidate who can lead and inspire a highly engaged and committed team and are willing to take risks.

As a Team Lead, you will provide strategic and managerial oversight of global clinical trial activities and contribute to the development of state-of-the-art processes related to trial planning, conduct, and oversight to ensure quality within strict timelines.

Besides having management responsibility, you will actively participate as Clinical Project Leader (CPL) in one or more Compound Development Teams (CDTs) responsible for driving the overall clinical operational strategy of projects/trials. It is anticipated, that you will spend half of your time on people management activities and support your team in both personal and professional development and half of your time on project related activities.

The position can be placed in either DK, NL, or US.

Responsibilities

• Set the direction and inspire/motivate your employees to deliver the best in a fast-paced environment

• Drive and lead successful execution of all operational aspect of global clinical trials/program using strong project management, leadership, and organizational skills

• Accountable for operational execution to support a diverse portfolio of work while proactively managing risks and issues

• Provide technical and strategic expertise to ensure consistent processes

• Support development of the global clinical trial budgets and review of workorders focusing on cost efficiencies, quality, and timelines

• Communicate regularly and effectively with relevant stakeholders including but not limited to clinical, regulatory, safety, project management, and other internal and external stakeholders

• Promote collaborative relations with stakeholders, vendors, consultants, and CRO’s in a global setting

• Management of resources across projects/activities

• Contribute to development of processes within Clinical Operations in accordance with new trends/standards and ICH-GCP guidelines

• Vendor management at the operational and strategic level

• Data process knowledge and strong IT skills with a passion for e-tools/digital devices would be an advantage

• KOL engagement

• Support development of improved start up processes

• Act as Clinical Project Leader (CPL) for one or more compounds

• Contribute to the development of clinical operational strategy/development plan within that portfolio of work

• Work collaboratively with colleagues/partners in EU, US and Japan and bring cultural diversity into play

Requirements

• Background within natural science and a scientific mindset

• A minimum of 10 years of experience within Trial Management preferably 3 years of managerial experience leading highly competent and dedicated team

• Track record in driving clinical trials phase I-IV

• Experience with Risk Based Monitoring

• Extensive experience with startup activities

• Ability to work in a matrixed organization

• Knowledge of FDA, EMA, PMDA, and ICH guidance for drug development pertaining to Trial Management

• Excellence in planning and execution of clinical trials within trial timelines

• Experience with the relevant regulatory requirements in relations to processes and SOPs

Moreover, you meet the following:

• Demonstrated ability to work independently, handle multiple priorities within timelines, and collaborate with other functions to resolve issues and improve efficiency

• Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, and external collaborators

• Go do attitude, creative, proactive, enthusiastic, out-of-the-box thinking, and goal orientated

• Significant experience managing to deliver results

• Demonstrated ability to collaborate with a diverse and global group of people including but not limited to data managers

Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.



At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.

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.

Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location 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.

Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website https://www.genmab.com/privacy.

Scam alert

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