Currently, we are looking for one or more Medical Director/Senior Managers with a medical background and experience from conducting and designing clinical trials. Preferably also experience with the pharmaceutical industry. You understand clinical trials and the associated regulatory framework, for example good clinical practice (GCP) and authority and ethical approval processes. We need people with clinical and/or scientific knowledge of obesity, metabolic disease areas and inflammatory/immunological disease areas. If this sounds like you, and you can drive a team towards a goal, you are a match for us.
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 trials for our drug candidates. The Medical & Science department consists of 8 Medical Experts and 5 Clinical Pharmacologists with diverse backgrounds. You will refer to the Head of Medical & Science. You will contribute to all medical and scientific aspects of one or more trials across all stages of clinical development. Zealand Pharma is undergoing a fast development with many near future opportunities depending on your competencies and engagement.
Responsibilities
- Contribute to clinical development plans for selected projects and trials, in close collaboration with the project teams
- Create clinical trial outlines ensuring fit for purpose design excellence in accordance with the strategy and the needs of the assigned drug development projects.
- Act as Zealand’s medical expert for selected clinical projects and trials
- Provide medical subject matter expertise to the clinical and projects teams as appropriate; liaise with other drug development disciplines regarding the conduct of trials, statistical methodology, data analysis, interpretation and reporting, and regulatory issues
- 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
- 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
- Work in accordance with applicable guidelines and regulatory plans/regulatory advice to ultimately support marketing authorizations
- 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
- Provide relevant post-approval medical and life-cycle support
Candidate profile
You will have most or all the below qualifications:
- Medical education is required, specialization not necessary
- Proven experience with hands on clinical research, for example preparing clinical trial plans, mechanistic trials, clinical pharmacology trials or later stage trials
- Clinical experience within one or more of obesity/metabolic/endocrine/inflammatory disease areas is preferred
- Scientific experience within relevant areas, PhD or equivalent is ideal
- Proven ability to drive and lead scientific project sub-teams towards results in a complex scientific field or in a pharmaceutical organization
- Experience from a team lead medical role or similar is an advantage
- You must be able to work independently and actively contribute as a highly collaborative team player
- You must have skills for project management and team leadership
Bonding to innovate
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.
Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.
We bond as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise.
We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience.
The Zealand Pharma DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.
Let’s bond and be bold
We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our 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 https://www.zealandpharma.com/careers/zealand-as-a-workplace/
Interested? Please apply no later than September 15th, 2024, or as soon as possible. The applications will be reviewed as they come in.
For further information, please contact Head of Medical & Science Thue Johansen, +45 5060 3889 or TJO@zealandpharma.com.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a Danish biotechnology company on a mission to change lives with next generation peptide medicines. In our effort to reach our goals bonding is at the core of everything we do. Let it be discovering and developing the best new peptide drugs for patients, engaging with partners or connecting with each other. This has led to more than 10 drug candidates invented by Zealand having 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 bond with us through LinkedIn.
