Auto req 13890BR
Job Posting Title Principal Scientist - PKDM
Career Category Clinical Development
Employee Subgroup Salaried FT
Country (State/Region) United States - California
Location (City) Thousand Oaks
Amgen Job Description Amgen is seeking a highly motivated and team-oriented candidate for the position of Principal Scientist in the Quantitative Pharmacology Group of PKDM Department. The Principal Scientist will serve as a PK/PD expert and Pharmacometrican to support Amgen Development and Discovery programs in the Oncology Therapeutic Area. The successful candidate will implement advanced modeling & simulation (M&S) strategy, develop M&S cutting edge methodology, and work collaboratively with cross-functional teams to optimize PK/PD study design and study protocol. He/she will be responsible for hands-on PK/PD analyses, modeling & simulations, report writing, and the preparation and maintenance of Investigator Brochures, IND/IMPD/CTX/RTQ/CTD, and other summary documents for regulatory submissions. He/she may transition into the role of PKDM Development Project Team Representative and independently represent the function area when appropriate. Development of junior members and interaction with the line-management will also be key responsibilities.
Basic Qualifications •Doctorate degree & 5 years of scientific experience
OR
•Master’s degree & 12 years of scientific experience
OR
•Bachelor’s degree & 15 years of scientific experience
Preferred Qualifications •PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 7+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training
•Specialized in PK/PD modeling and population-based analyses/simulations with established track-record records of model-based drug development
•Experience in supporting preclinical/clinical PK, PK/PD, and modeling & simulation components of regulatory documentations.
•Leadership quality for effective team building with strong decision making and problem solving skills
•Excellent interpersonal, technical, and communication skills to lead cross-functional teams
•Candidate with R&D experience to support small and/or large molecule oncology therapeutics
•Demonstrated experience with modeling and simulation software (e.g. NONMEM, SAS, S-Plus, Pharsight Clinical Trial Simulator)
•Excellence and eminence in field of PK/PD and modeling & simulation with peer-review articles and external presentations.
