Head of Clinical Development - Denmark
About Glycom A/S
We are a young and vibrant Danish biotechnology company focussed on the production and commercialisation of human milk oligosaccharides (HMOs). We are a world leader in the field and have an ambitious program to develop HMOs for the benefit of human health and have a pipeline of clinical trials. We employ a dynamic, multinational and successful team specialised in biotechnology research and production, and human biology. Our leading HMO products are approved in the EU and US and are entering the market in infant formulas. Further, we are opening up markets for new applications.
The job and the ideal candidate
We are looking for an experienced clinical development professional who can lead our clinical development and manage a global pipeline of clinical trials. You are a team player, solution orientated, have drive and attention to detail, and a passion for innovation in the field of human health. You are comfortable in providing challenging perspectives on where it really makes sense to invest in clinical trials. You will be a member of the business development team which includes preclinical and clinical development and reporting to the Head of Business Development.
- Lead and drive clinical development, clinical development standards, and a clinical trial pipeline, and actively contribute to the innovation pipeline
- Lead and manage cross-functional study teams for study design and to manage and maintain study time lines and budgets
- Lead and drive study design and planning including protocols, time lines, budgets, resources, risk management, and sites
- Lead selection and evaluation of study sites and vendors, including overseeing negotiation of budgets and financial and other terms with sites
- Ensure study execution including obtaining approvals, start up, enrolment tracking, monitoring, follow up and close out.
- Lead and drive data management, review, analysis, reporting and publications
- Communication of study results to key stakeholders
Required qualifications and attributes
- A degree (BSc, MSc, MD, PhD) in a scientific discipline related to human biology and health. Additional qualifications in clinical trial management are a plus.
- At least 5 years experience in the management of clinical trials and a thorough understanding of clinical research. Experience in smaller entrepreneurial setting, with food trials and trials involving gastroenterology are a plus.
- Knowledge of GCP and regulatory guidelines and directives relevant to clinical trials.
- Excellent command of English and the ability to communicate clearly with key stakeholders; both internal and external.
- Ability to lead and motivate teams and establish partnerships with key stakeholders.
- Ability to work within and contribute to a dynamic, interactive and informal innovation team.
Salary and terms of employment
This is a permanent and full time position. We offer a competitive package based upon qualifications. The position is based in Scion DTU Science and Technology Park in Hørsholm, which is located 20 km north of Copenhagen.
Please send your application and CV via StepStone and kindly indicate your earliest availability. If you wish to learn more about the job, please get in touch with Bruce McConnell, Head of Business Development (firstname.lastname@example.org). Please apply via StepStone as soon as possible as we review applications on an on-going basis. For further information about Glycom please visit our homepage www.glycom.com or follow us on LinkedIn.