Development Operations Innovation Director

Company: Amgen Inc.
Location: Thousand Oaks
Posted on: May 3, 2021

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Development Operations Innovation Director

Live

What you will do

Let's do this. Let's change the world. In this vital role you will lead innovation efforts in Global Development Operations (GDO) with a focus on speed, flexibility, quality, and productivity. In partnership with other Global Development functions, R&D IS, and the R&D Functional Transformation Office, you will advance the roadmap for Amgen's future clinical trial execution capabilities and services. The Director will maintain strong internal and external network to stay informed of industry trends and evolving regulatory requirements in order to support the GDO leadership in future-proofing the trial execution model. This position reports to the Executive Director, Innovation & Process Improvement.

The Director will have the following responsibilities:

• Within the Innovation & Process Improvement team, lead efforts to identify high impact opportunities to advance Amgen's study execution model, and advance selected efforts from proof of concept to pilot and implementation
• Act as a thought leader and partner to internal and external stakeholders to drive innovation across Global Development's clinical evidence generating platform.
• Partner with stakeholders within Global Development to develop and advance business cases that support corporate objectives and functional goals tied to speed & cycle time acceleration, productivity, quality delivery, and operating model flexibility
• Direct management of select Global Development Operations and Clinical Trials Global Networks initiatives and projects as required
• Develop and maintain relationships with external clinical operations benchmarking experts
• Provide technical expertise on organizational wide initiatives
• Drive change management & communication efforts needed to embed and sustain new ways of working within the organization

Win

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 4 years of clinical development or application of transformative technologies experience
• OR Master's degree and 7 years of clinical development or application of transformative technologies experience
• OR Bachelor's degree and 9 years of clinical development or application of transformative technologies experience

Preferred Skills:

• 11+ years of work experience in product development or technology management, including 8 years of biopharmaceutical clinical-focused work (includes clinical research and clinical operations experience obtained at a biotech, pharmaceutical or CRO company)
• Previous experience with disruptive innovation, including technical implementation, communication, and navigating organizations through change.
• Strong understanding of operationalizing clinical development programs in a global setting
• Experience in innovative study design (e.g. Master Protocols, multiphase adaptive trials)
• Project and program management including leadership throughout study lifecycle (i.e. SSU, maintenance, and close-out)
• Experience in leading projects in a matrix organization
• Knowledge of new and emerging trends and practices in clinical research, including but not limited to mHealth, remote trial risk management, predictive analytics, and decentralized trials.
• Broad knowledge of project and resource management practices in the pharmaceutical industry.
• Broad knowledge of process assessment and design practices
• Application of change management principles and practices
• Deep understanding of drug development process, including GCP and global regulatory requirements

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com

Equal Opportunity Statement

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

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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.

Keywords: Amgen Inc., Thousand Oaks , Development Operations Innovation Director, Other , Thousand Oaks, California