(+45) 29 44 00 80 / kontakt@beirholmsearch.dk

Team Lead, Trial Management

Team Lead, Trial Management
oktober 9, 2019 Hanne Beirholm
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Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

The Role

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

As Team lead 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 Team Lead 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 Team Lead, Trial management, you will lead a team of 12-15 highly competent and experienced employees, 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 team lead 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.

This is a fantastic opportunity to join Genmab – a highly innovative biotech company with a rich pipeline and at the forefront of cancer therapy development. It is a small organization with a short chain of command and a unique opportunity to influence our interesting journey  – so is it time to take the next important step in your career?

 

Main Responsibilities

  • Set the direction and inspire/motivate your staff members to deliver the best in a fast-paced environment.
  • Drive and lead successful execution of all operational aspects of global clinical trials/programs 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 work orders focusing on cost efficiency, 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.
  • 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

Qualifications

  • 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 a highly competent and dedicated team.
  • Track record in driving clinical trials phase I-IV.
  • Aability 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.
  • Demonstrated ability to work independently, handle multiple priorities within timelines, and collaborate with other functions to resolve issues and improve efficiency.
  • Data process knowledge and strong IT skills with a passion for e-tool/digital devices would be an advantage.
  • Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs and external collaborators.
  • “Go do” attitude, creative, proactive, enthusiastic, “outside the box”, 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

A team player, enthusiastic, passionate about bringing important new, innovative products to oncology patients. Actively continue to further build the group of highly qualified employees in the Trial management team.

 

Other

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 applicant a challenging position, where the right candidate will have the opportunity to work with highly specialized 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.

If you would like additional information about this position before applying using the link, please contact Hanne Beirholm, Beirholm Search. Tel. +4529440080 /mail: kontakt@beirholmsearch.dk





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