Zealand Pharma A/S (Zealand) is a Copenhagen-based biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. 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. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence the U.S. as well..
Do you have a medical background, experience from designing trials and drug development programs and a track record in clinical research and science within gastro-intestinal, rare diseases or metabolic disease areas? Do you have the drive and the talent for leading a medical and scientific project team? Are you motivated by supporting, learning and collaborating? Then you have the chance to become the Medical Director in one or more Zealand projects.
The Medical & Science department in the Development area consists of 4 Medical Directors and two Clinical Pharmacologists with diverse backgrounds. We are looking for a self-driven team-oriented colleague with the capability to lead cross-functional teams towards innovative solutions for delivering the highest standard clinical development program for our drug candidates. You will refer to the Head of Medical & Science. Depending on your level of experience you will contribute to all medical and scientific aspects of the project in early and late-stage clinical development projects.
Responsibilities include to:
- Create and guide clinical development plans for selected projects, in close collaboration with project teams
- Work in accordance with applicable guidelines and regulatory plans/regulatory advice to ultimately support marketing authorizations
- Provide relevant post-approval medical and life-cycle support
- Create clinical trial outlines ensuring fit for purpose design excellence in accordance with strategy and the needs of early and late-stage drug development projects
- Support execution of the strategy and other project related tasks on-time and with the highest quality
- Support the clinical team in executing the clinical development plan
- Act as Zealand’s medical expert for selected clinical projects and trials
- Ensure proper medical monitoring, including when the role is delegated to appropriately qualified medical personnel, such as outside consultants or CROs in accordance with SOPs
- Provide medical subject matter expertise to the clinical and projects teams as appropriate; liaise with other drug development disciplines regarding the conduct of experiments, statistical methodology, data analysis, interpretation and reporting, and regulatory issues
- Write essential part of the documentation required to support conduct of the clinical program and the documentation required to respond to regulatory agencies regarding any clinical queries and for product approval by regulatory agencies
The successful candidate will have most or all the below qualifications:
Medical education is required, specialization not necessary
Clinical experience within endocrine/metabolic or gastrointestinal/inflammatory areas is preferred
Scientific experience within relevant areas, PhD or equivalent is ideal
Experience with drug development or clinical research is a must
Proven ability to drive and lead scientific project sub-teams towards results in a complex scientific field or in a pharmaceutical organization
Proven pharma experience with preparing clinical development plans, clinical pharmacology trials or later stage trials.
Experience with regulatory affairs, regulatory agency meetings and drug registration is preferred
You must be able to work independently and actively contribute as a highly collaborative team player
You must have skills for project management and be able to get people on board in your team
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.
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, and bonus. 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 www.zealandpharma.com.
Application Please apply no later than August 24th, 2022, or as soon as possible. The applications will be reviewed as they come in.
For further information, please contact Thue Johansen at +45 5060 3889 or TJO@zealandpharma.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.