Be the new
Experienced Senior Medical Manager/Medical Director for drug development projects (Type 1 diabetes and obesity)
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 two products on the market and three candidates in late-stage development, 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).
Do you have either a medical background combined with experience from drug development and a track record in clinical research and science within type 1 diabetes or obesity/metabolic disease? You will lead the scientific and medical drug development through uncharted pathways which requires a good understanding of the relevant clinical and regulatory environments. Do you have the drive and the talent for leading a medical and scientific project team? Then you have the chance to become the medical lead in one or more Zealand projects.
Responsibilities include helping us to:
The Medical & Science department in the Development area consists of 5 medical doctors 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. As we are building our organization and capabilities there will also be opportunities for contributing to or leading cross-functional development of processes, methods and change management.
The successful candidate will have most or all the below qualifications:
- Progress assigned project as a member of the project leadership team, and lead the project's Medical & Science team or clinical pharmacology activities
- Create and guide clinical development plans for selected projects, in close collaboration with project teams in accordance with applicable guidelines and regulatory plans/regulatory advice to ultimately support marketing authorizations, and to provide relevant post-approval medical and life-cycle support
- Create clinical trial synopses ensuring the adequate 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
- Acting as Zealand’s medical expert/clinical pharmacology expert for selected clinical projects and trials
- Ensuring proper medical monitoring, including when the role is delegated to appropriately qualified medical personnel, such as outside consultants or CROs in accordance with SOPs
- Providing (medical) subject matter expertise to the clinical and project teams as appropriate; liaise with other drug development disciplines regarding the conduct of experiments, statistical methodology, data analysis and interpretation, and regulatory issues
- Writing 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
- Support the translational process from research to development for new drug candidates, including biomarker strategy and indication finding.
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.
- Medical degree is required, specialization not mandatory
- Clinical experience within endocrine/metabolic 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 complex scientific field or pharmaceutical organization
- Proven pharma experience with preparing clinical development plans, clinical pharmacology plans or later stage trials
- Experience with regulatory affairs and regulatory agency interaction is preferred, including contributions to the regulatory strategy and contributions to external documents is preferred
- You must be able to work independently and actively contribute as a highly collaborative team player
- You must have a skill for project management and be able to get people on board in your team.
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 employee share 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 www.zealandpharma.com.
Please apply as soon as possible - interviews will be ongoing in the period - and no later than November 30, 2021.
For further information, please contact Head of Medical & Science, Senior Director 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.