Cyxone is currently recruiting a Head of Clinical Trials.
Head of Clinical Trials to Cyxone
Cyxone is a Swedish biotech company that develops disease modifying therapies for autoimmune disorders such as rheumatoid arthritis and multiple sclerosis as well as treatments for virally induced acute respiratory disorders.
At Cyxone we consider the unmet need from an alternative perspective. The company’s vision is to develop therapeutics that markedly improve the quality of life for patients based on recent understandings of the disease mechanism. Our drugs are designed not only to be efficacious, but also more convenient for patients to take, have fewer and milder side-effects than existing treatments, and well-suited for long-term treatments. By providing this we will offer patients the option of taking control of their disease, and thereby their lives.
Currently Cyxone has two projects in phase II, one for Covid-19 and one for rheumatoid arthritis.
Cyxone is now looking for a Head of Clinical Trials
He/she will be responsible to plan, lead and coordinate clinical phase projects throughout the development life cycle, and to provide medical/scientific input and expertise to existing and new development projects.
The Head of Clinical Trials will work in close collaboration with the Head of Development, COO and CEO. He/She will manage and interact with external partners such as Clinical CROs, Regulatory authorities and CMOs, and also with CMC and Formulation experts. . Vendor management is a key task, ensuring that the projects are delivered to budget, high quality, and timelines as well as resolving any issues.
The candidate has 10+ years of experience in the biotech/pharmaceutical industry and from early and late-stage clinical development, as well as of the late pre-clinical development phase. He/she has a solid understanding of the full drug development process.
The person needs to be very organized, highly motivated and goal oriented. It is important to be able to work independently, take initiatives and make decisions. The candidate should be a problem solver, always looking for solutions, be comfortable to work in an international setting and to perform in a partly virtual organisation.
Qualifications & Key skills
- Medical, Pharmacist or other Life Science degree, preferably Master degree. PhD is a merit.
- Experienced clinical project leader in Phase I-III.
- Comfortable preparing presentations and presenting results is a merit
- Strong understanding of ICH-GCP and other relevant regulations and guidelines in relation to clinical trials
- Experience in working with CROs and vendors, critically evaluating competing proposals, negotiating as well as supervising and following up.
- Understanding of regulatory environment and experience with regulatory authority contacts, submissions and approvals.
- Experience in developing study protocols as well as compiling clinical documents to registration dossiers.
- Experience from work in a small biotech company is an advantage.
- Knowledge of Multiple Sclerosis, Rheumatoid arthritis or other autoimmune diseases is a strong merit. Knowledge of Viral respiratory infections (VRI) is a benefit.
- Experience of peptide drug development is an advantage.
- Fluency in English, both in oral and written communication, Swedish is a merit, but not required.
- Substantial knowledge in MS Office (Word, Excel, Power Point) and experience of MS Project.
Opportunities with the position
- To work for a small innovative dynamic biotech company at an exciting stage and with projects of great potential
- Possibility to make a significant difference for the company and for the patients.
- Opportunities for personal and professional development
- Location is flexible. Cyxone is based in Malmö. Proximity to Malmö is desirable but not required.
- Travelling both within and outside Sweden will be required (once restrictions permit)
- Start date as agreed.
For more information, please visit www.cyxone.com
Please apply May 16th at the latest.
For questions or application, please contact:
Telephone: +46 (0) 70 396 94 79
By sending your resume to Cyxone, you agree to:
- The processing of your personal data is necessary for the purpose of the legitimate interests pursued by Cyxone to manage its recruitment activities
- Should your application be successful, your personal data will become part of your employment record and will be subject to the retention periods mentioned in your contractual agreement
- In order to contact you regarding future job opportunities, which we think may be of interest to you, your CV will be kept for a period of 2 years following your last interaction with us.
- Your data could be deleted immediately following contact our DPO: DPO@cyxone.com