Senior Scientist Clinical Pharmacology - Swedish Orphan Biovitrum - Sobi - Avslutad
Your focus will be clinical pharmacology from early-development (pre-IND) through late-stage development (worldwide filings and life cycle management) within the Clinical Pharmacology and DMPK section. The section is responsible for clinical pharmacology as well as DMPK and bioanalysis throughout all stages of preclinical and clinical development. The work is focused on biotechnology products and performed in close partnership with colleagues in Clinician Operations, Medical Writing & Biostatistics, Regulatory, Drug Safety, Therapeutic Area Medical Development and Non-Clinical Pharmacology.
- Participating in the design of clinical studies and programs
- Planning, writing, and reviewing clinical study protocols, statistical analysis plans etc.
- PK and PK/PD data analysis and interpretation using state of the art modeling and simulation strategies
- Integration of PK and PD concepts into decision making processes, e.g., to ensure that appropriate dose and dosing schedule decisions are made
- Writing and reviewing study reports, and regulatory documents such as IBs, INDs, briefing documents for regulatory meetings and relevant sections of eCTDs
Ph.D. in in relevant scientific area and 5 years of clinical pharmacology experience or a minimum of a Master´s degree in relevant scientific area with 10 years of clinical pharmacology experience. Qualified experience from work with biological pharmaceuticals.
Experience and requirements:
- Extensive experience with protocol design, in particular clinical study protocols focused on clinical pharmacology elements (FIH, SAD, MAD, BA/BE, DDI, special populations, etc.)
- Profound knowledge of pharmacokinetic and pharmacodynamic concepts and its integration into decision making processes
- Strong knowledge of state-of-the-art PK and PK/PD modeling and simulation techniques including hands-on experience with PK/PD analysis and modeling software, i.e. WinNonlin, Phoenix or equivalent
- Qualified experience of Clinical Pharmacology work with biologics
- Deep understanding of relevant regulatory requirements and solid experience in working with documents for regulatory submissions
- Solid understanding of the drug development process and issues specific to clinical pharmacology of biotechnology products
- Experience of clinical trials with orphan drugs/specialty pharmaceuticals
- Experience of clinical trials in pediatric populations
- Fluency in English - both oral and written communications
- Energetic, driven, able to take initiative with a can do attitude
- Results and delivery focused as well as a structured way of working
- Good problem-solving ability and analytical mindset
- Open, flexible, interested in colleagues´ perspectives, a team player
- Strong sense of personal accountability working independently as well as a strong ability to work in teams
- Excellent written, presentation, and verbal communication skills
Attributes in relation to Sobi’s values “CARE” (Collaborative, Accountable, Respectful, Engaged). Collaboration will be a key requirement, you will work in a highly interactive environment.
Location: The position is based in Stockholm.
Please contact Knut Natt och Dag on +46 722 166 800 if you would like further information. Send your application containing your CV and a personal letter to email@example.com, write “Sr Clinical Pharmacologist” in the subject field. We are working continuously with this recruitment and would like to have your application as soon as possible.