14 days old

Senior Clinical Research Study Manager

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    130640047
Amgen

Job ID: R-112694
Location: Thousand Oaks, CA, US

Job Description:Senior Clinical Research Study Manager

Biosimilars are an important development for Amgen and for patients globally. The opportunity to provide patients with greater access to critical therapies furthers the Amgen mission to serve patients.

Quality biosimilar development requires a new paradigm, integrating all the science and experience at Amgen developing biologics as well as our quality manufacturing while creatively and rapidly executing a streamlined and efficient method for study execution to demonstrate comparability to the originator product.

The Sr. Manager Study Management will lead study execution within a full-service CRO model.

Responsibilities:

- Coordinate and oversee the planning, management, execution, and reporting of Biosimilar clinical trials in close partnership with CROs in a full-service CRO model

- Ensure execution of assigned Biosimilar clinical trials with high quality, on time and on budget

- Management of study timelines, oversight of CRO study team performance, scopes of work, and budget

- Identify and resolve cross functional issues and regional issues associated with study execution in partnership with CRO

- Ensuring implementation of studies in accordance with applicable SOPs and ICH/GCP guidelines

- Contribute to the authoring and review of key study documents and plans (eg, protocols, ICFs)

- Collaborate with the global study team and CRO partners to ensure operational excellence and efficiencies

- Communicate program status and issues

- Integration and oversight of Amgen and CRO processes for efficient study execution and quality delivery

- Support of strategic planning and regulatory interactions including IND/BLA applications and regulatory inspections

- Leading initiatives and process improvement work streams

- Domestic and international travel up to 10% as needed

Basic Qualifications:

Doctorate degree and 2 years of clinical experience

OR

Master's degree and 6 years of clinical experience

OR

Bachelor's degree and 8 years of clinical experience

OR

Associate's degree and 10 years of clinical experience

OR

High school diploma / GED and 12 years of clinical experience

Preferred Qualifications

Master's degree in sciences

7+ years work experience in life sciences or medically related field, including 5 + years of biopharmaceutical clinical research experience obtained working on industry-sponsored, global clinical trials in biotech, pharmaceutical or CRO company

Excellent cross-functional coordination within Amgen and with CRO partner(s)

Experience in leading cross-functional teams

Broad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines

Solid understanding of Biopharmaceutical/Healthcare Compliance.

Knowledge to present and evaluate strategies for clinical development and critically evaluate outside expert or vendor advice

Flexibility and ability to streamline processes and work under pressure

High level of personal accountability

Highly responsive and ability to multi-task

Experience in inflammation therapeutic area

Proven ability to anticipate and resolve problems

Experience writing and presenting clearly on scientific and clinical issues

Excellent interpersonal and organizational skills

Excellent oral and written communication skills.

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.



PI130640047
Posted: 2021-02-19 Expires: 2021-03-23

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Senior Clinical Research Study Manager

Amgen
Thousand Oaks, CA 91360

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