Be the new
Senior Clinical Trial Manager
in a biotech company focused on the discovery, design and development of innovative peptide-based medicines
Zealand Pharma A/S (Zealand) is a fast-growing, fully integrated Copenhagen-based biotechnology company with a highly attractive pipeline. With one product on the market, one candidate in registration and six candidates in the clinical pipeline, Zealand is a unique success story in Danish biotech. We are passionate about improving the quality of life for patients with metabolic and gastrointestinal diseases, and other specialty or rare disease areas with significant unmet medical needs. In addition to the Søborg Headquarters, Zealand is also located in the United States in Boston (MA), Marlborough (MA), and New York (NY).
Zealand Pharma A/S (Zealand) is seeking an experienced Clinical Trial Manager to join the Clinical Operations Department. The department is responsible for setting up, overseeing and reporting clinical trials in close collaboration with CROs. Together with your Zealand Pharma collegues and CRO team you will be responsible for delivering well conducted clinical trials within agreed timelines and budget.
The clinical operations group is composed of a dynamic team with 16 enthusiastic and professional colleagues. We have an open and respectful environment encouraging collaboration and knowledge sharing. We welcome new ideas and approaches.
Responsibilities includes helping us to:
The successful candidate will have most or all of the below qualifications:
- Design, plan, conduct and report local and global clinical trials
- Lead the clinical trial team - ensure good collaboration and communication within the team
- Secure a successful trial conduct and trial deliverables
- Drive the selection of and contracting process with CROs
- Lead the collaboration with CROs.
- Do risk assessment and quality risk management of the clinical trials and the development of sponsor oversight plans, systems and activities
- Maintain good relationships with clinical trial sites
- Provide input to the clinical development plans and regulatory authority interactions when relevant
- Adhering to and advancing the clinical operational procedures.
What we offer
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
- An academic degree in medical, biological, health, veterinarian or pharmaceutical sciences
- A minimum of 5 years relevant clinical trial execution experience
- Strong project management skills
- Experience from collaborating with CROs or working in a CRO
- Solid knowledge and experience within GCP, ICH and FDA/EMA regulations
- Proficiency in written and spoken English
- Strong communication skills
- A quality mind-set
- A ‘can-do’ attitude, seeking solutions and adding ‘non-obvious’ perspectives
- Able to keep perspective and priorities in a busy working environment
- A ‘super-collaborator’ personality
- Motivation and passion for clinical trials; being an inspiring team player
Our work environment is characterized by strong cross functional team-work, room for individual performance and development, informality and respect, high work-ethics and engagement, and fun.
At Zealand, we understand the value of a diverse workforce. As an employee, you will be part of an innovative, cross-disciplinary and cross-cultural working environment.
We offer a combined compensation package which includes a base salary, pension, bonus, and an attractive warrant program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities. To find out more about working at Zealand, visit our careers site and view our company video at:
Please apply no later than October 1, 2020.
For further information, please contact Gertrud Koefoed Rasmussen at +45 5060 3773 or email@example.com
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals.Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on LinkedIn or Twitter @ZealandPharma.