Preclinical Manager

We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.

The department of Clinical Pharmacology, Modeling and Simulation (CPMS) within Amgen is dedicated to the development of novel, effective, and safe medicines. We are seeking a highly experienced Clinical Pharmacology Manager to join the CPMS group in Thousand Oaks, California.

The successful candidate will contribute to Amgen's multi-modality development portfolio by writing and reviewing key clinical pharmacology study documents, data, and reports, facilitating team discussions around study designs, conducting quality control, and adhering to applicable regulatory guidance (i.e., good clinical practices [GCP]). In addition, the successful candidate will possess good written and oral communication skills, the ability to work well in teams, will demonstrate technical aptitude and a strong work ethic. The individual will also be responsible for review and compliance with all applicable SOPs, standard operating procedures business practices and company policies.

The primary core responsibilities of the Clinical Pharmacology Manager will include:

• Execution/review of several clinical pharmacology study documents, data reviews, and reports
• Support oversight of clinical trial activities (including start-up, mid-study monitoring, and reporting)
• Review and quality control of data analyses and key study documents to ensure accuracy and consistency in accordance with standard processes
• Work closely with CPMS and other team members, effectively communicate with project team representatives and actively participate/collaborate cross functionally

Basic Qualifications

Doctorate degree
OR
Master's degree and 3 years of relevant pharmaceutical or biotech experience
OR
Bachelor's degree and 5 years of relevant pharmaceutical or biotech experience
OR
Associate's degree and 10 years of relevant pharmaceutical or biotech experience
OR
High school diploma / GED and 12 years of relevant pharmaceutical or biotech experience

Preferred Qualifications

• Bachelor's or Master's degree in life sciences such as biology, chemistry, or related field.
• 5+ years of experience conducting, managing, or executing clinical trials
• Experienced in working with clinical trial study documents, reviewing data, and clinical trial study reports
• Familiar with the drug development process and clinical pharmacology studies
• Attention to detail and strong analytical, writing, communication, organization, and teamwork skills
• Skilled in using Microsoft Office software (i.e., Word, Excel, PowerPoint)
• Able to work under tight deadlines

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.