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Director, Head of Trial Management

Director, Head of Trial Management
maj 4, 2021 Hanne Beirholm
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Genmab is looking for an experienced Director, Head of Trial Management within Oncology

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

The Role

In order to further strengthen Trial Management in advancing our innovative antibody pipeline Genmab is looking for an experienced Director, Head of Trial Management within Oncology.

As Director, Head of Trial Management, the employee will be accountable for all aspects of assigned clinical trials /programs spanning early development to late development within Clinical Operations. The employee is responsible for providing strategic and managerial oversight of global clinical trial activities and drive the development of state-of-the-art processes related to trial planning, conduct and oversight to ensure quality within strict timelines.
As Director, Head of Trial Management, you will lead a team 7 highly competent and experienced employees (CTM and CTA´s), and it is essential that you can lead and inspire a highly engaged and committed team and are willing to take risks.
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 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.
As Director, Head of Trial Management, you will be part of the Clinical Operations Leadership Team (COLT) defining the overall strategy and development areas within Clinical Operations and partner with senior management, clinicians, pharmacologists, translational research to support clinical development activities within Oncology in a partly outsourced setting.

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, excellence in planning and execution of clinical trials within trial timelines.
  • 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
  • Part of the leadership team within Clinical Operations (COLT)
  • Management of resources across projects/activities
  • Drive 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) on 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 start up activities
  • Ability to work in a matrixed organization
  • Knowledge of FDA, EMA, PMDA and ICH guidance for drug development pertaining to trial management
  • 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. clinical, scientists, translational research

Genmab:
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. 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 culture, all aiming to make a difference for cancer patients.
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. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.
Founded in 1999, the company is the creator of four approved antibodies. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab’s technology base consists of validated and proprietary next generation antibody technologies and intends to leverage these technologies to create opportunities for full or co-ownership of future products.
Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

More information, application:
If you have any questions, please feel free to reach out to Hanne Beirholm, Beirholm Search at +45 29440080
Or kontakt@beirholmsearch.dk
Please send your application on the following link.





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