Clinical Scientist Associate Director, Late Development Obesity

Career Category

Clinical Development

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Clinical Scientist Associate Director – Late Development, Obesity Therapeutic Area

What you will do

Let’s do this. Let’s change the world. In this role, the Clinical Scientist Associate Director supports late-phase clinical development by contributing to protocol development, study start-up, data review and monitoring and analysis activities. Working collaboratively with the study team and clinical leadership, this role focuses on study-level implementation and cross-functional coordination to help ensure high-quality, decision-ready clinical data.

• Support set up and execution of late phase clinical trials with a focus on data quality
• Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
• Provide input into & implementation of data management plan, CRF design, and data review oversight
• Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
• Assists Development Lead and Clinical Scientist Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
• Anticipate and actively manage problems across a broad spectrum of cross-functional teams
• Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
• Support appropriate training, recruitment, and development requirements for matrix team resources

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The clinical development professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 3 years of clinical development experience

OR

Master’s degree and 5 years of clinical development experience

OR

Bachelor’s degree and 7 years of clinical development experience

OR

Associate’s degree and 12 years of clinical development experience

OR

High school diploma / GED and 14 years of clinical development experience

Preferred Qualifications:

• 3 years of pharmaceutical clinical drug development experience
• Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
• Industry or academic experience supporting early or late-phase drug development within a relevant therapeutic area or disease indication
• Strong communication and presentation skills, with the ability to clearly convey scientific concepts and clinical data to cross-functional teams and leadership audiences, both written and oral
• Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
• Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
• Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance
• Experience serving as a contributing author on scientific publications or data presentations for internal forums or scientific conferences
• Experience in clinical data analysis such as Spotfire or other data analysis tools 

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collabor