Join the Bioanalysis / PKPD Team in a leading and fast-growing biotech company
Ascendis Pharma is currently expanding its Bioanalysis amp; PKPD Team.
Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical need ?. Then Ascendis Pharma is committed to support your personal development in our rapidly growing innovative company.
Ascendis Pharma is looking for an experienced scientist to join our team that covers Bioanalysis, PKPD, Immunogenicity amp; modelling in the Nonclinical Development amp; Bioanalysis Department.
You will provide input to bioanalytical assay strategy (PK amp; immunogenicity), development amp; operation. The role will include outsourcing bioanalysis work to vendors/CROs to develop, transfer and validate assays and monitor study conduct.
The role also includes analysis of immunogenicity and non-compartmental PK(/PD data and interpretation of these data for nonclinical amp; clinical studies. We seek an experienced, detail-oriented and results focused scientist who is passionate about drug development and making a difference in patients’ lives.
The successful candidate will add their passion, talent and expertise to a dynamic team on the frontline of innovative therapeutic development.
This new position is based in Hellerup, Denmark and will report to the Director Bioanalysis amp; PK/PD.
Main areas of responsibility:
- The individual will design, conduct, coordinate and outsource PK amp; immunogenicity bioanalysis as well as analyze and interpret data from multiple nonclinical amp; clinical studies on endocrinology amp; oncology programs.
- The outsourced bioanalysis amp; immunogenicity assays will involve methods for large and small molecules and methodologies including Immunoassay amp; LC-MS/MS.
- Close collaboration with nonclinical, clinical and biometrics colleagues and vendors to interpret data.
- Communicate findings to relevant stakeholders, including project teams and senior management.
- Author high quality documents contributing to bioanalysis and PK strategy documents and reports, bioanalysis sections of clinical protocols and reports, regulatory documents, scientific manuscripts and external presentations.
Criteria of success in the role will be:
- Experience with assay development amp; validation in a GLP/GCP environment, input to protocol, lab manual, CSRs and regulatory documents.
- Experience with outsourcing analytical methods including platform/vendor selection and contracting would be an advantage.
- Ability to perform and interpret non-compartmental amp; compartmental pharmacokinetics (Phoenix).
- Understanding of drug discovery and development in both early and late stage development and familiarity with regulatory approval process.
- The role requires strong communication and stakeholder management skills.
- Desirable to have experience of small and large molecule assay development in endocrinology or Immuno-oncology drug development.
- A proactive and self-motivated individual with a strong drive, ability to work in a dynamic environment and able to manage multiple objectives in parallel and adapt to changing priorities.
- A positive attitude and good collaboration skills to establish professional engaging relations internally and externally and to communicate effectively providing clear recommendations to study teams, project teams and other stakeholders. You are comfortable in a dynamic environment in which priorities may quickly change. Finally, you have a personal commitment to delivering results and to succeed.
- Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance Ascendis Pharma’s exciting product pipeline.
You hold a relevant MSc degree in Chemistry, Biotechnology, Pharmacy or other related Life Science area. Additionally, you have at least 3 years of experience within the main areas of responsibility.
Travelling: 10-15days per year.
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbour, the canals, and the sea.
For more details about the job or the company, please contact Paul Martin, Team leader Bioanalysis amp; PK/PD on M + 45 23 33 32 11 or . All applications must be submitted i