21 days old

Director, Operational Design

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117640054
Amgen

Job ID: R-92808
Location: Thousand Oaks, CA, US 91360

In our mission to serve patients, speed and predictability are absolutely critical. The Director, Operational Design will lead the Operational Design Team to advance study teams' use of data, patient insights, and recruitment strategies to enable optimized operational planning and consistent operationally coordinated study design and protocol.

The Operational Design team:
  • 5 Operational Design Leads who drive study teams to develop an operationally integrated study design and protocol, including feasibility, risk assessment, data elements planning, and patient insights.
  • 2 Operational Design Analytics Senior Managers who work with study teams during trial design, planning, and start-up to drive the use of data to inform operational planning and improve the probability of executing within schedule and budget.


The Director, Operational Design joins the Global Clinical Program Management (GCPM) function. You will play a key role across Global Development leading the Operational Design team to drive realization of the full potential of data sources at Amgen to support evidence based optimized operational planning and an operationally integrated feasible study design.

We are excited to unite with the most hardworking and forward-thinking scientific minds who want to join Amgen- working toward our mission of advancing high potential programs for patients around the world.

Responsibilities:
  • Lead and manage the team and develop staff in these vital new roles
  • Drive strategy and execution for the use of data sources in operational design and planning to improve predictability and speed of execution
  • Enable and support continued evolution of the Operational Design Lead and Operational Design Analytics roles
  • Partner with Clinical Program Managers to ensure consideration of innovative patient recruitment strategies and patient voice during operational design and planning
  • Partners with Global Network Leads and Business Process Owners to advance processes in support of the new capabilities and roles.
  • Collaborate with stakeholder functions including Center for Design and Analytics (CfDA) Data Sciences, CfDA Design & Innovation, Center for Observational Research and Global Development Operations leadership to identify new opportunity and findings to support planning and execution of clinical trials
  • Demonstrate external knowledge of industry standard methodologies, processes and new trends
  • Support introduction and scaling of significant operational innovations


Basic Qualifications:

Doctorate degree and 4 years of Clinical experience

OR

Master's degree and 8 years of Clinical experience

OR

Bachelor's degree and 10 years of Clinical experience

Preferred Qualifications:
  • M.D., D.O., PhD, PharmD, MSc
  • 11+ years work experience in life sciences or medically related field, including 8+ years of biopharmaceutical clinical research experience obtained working in clinical development at a biotech, pharmaceutical or CRO
  • Strong understanding of operationalizing clinical development programs in a global setting
  • Experience with the implications of protocol design and operational planning on trial execution
  • Experience in using data and analytics to inform clinical trial planning and design
  • Expertise in clinical data sources and understanding of how and when to apply them
  • Experience with time, cost and quality metrics
  • Experience leading projects in a matrix organization
  • Experience in leading organizations through change
  • Proactive problem solving through innovative and pragmatic solutions
  • Previous management experience of direct reports
  • Experience in developing goals and training plans to improve talent and career development of staff


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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded teamwork, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses 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.

PI117640054

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92808<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>In our mission to serve patients, speed and predictability are absolutely critical. The Director, Operational Design will lead the Operational Design Team to advance study teams' use of data, patient insights, and recruitment strategies to enable optimized operational planning and consistent operationally coordinated study design and protocol.<br><br>The Operational Design team:<br><ul><li>5 Operational Design Leads who drive study teams to develop an operationally integrated study design and protocol, including feasibility, risk assessment, data elements planning, and patient insights.</li><li>2 Operational Design Analytics Senior Managers who work with study teams during trial design, planning, and start-up to drive the use of data to inform operational planning and improve the probability of executing within schedule and budget.</li></ul><br><br>The Director, Operational Design joins the Global Clinical Program Management (GCPM) function. You will play a key role across Global Development leading the Operational Design team to drive realization of the full potential of data sources at Amgen to support evidence based optimized operational planning and an operationally integrated feasible study design.<br><br>We are excited to unite with the most hardworking and forward-thinking scientific minds who want to join Amgen- working toward our mission of advancing high potential programs for patients around the world.<br><br>Responsibilities:<br><ul><li>Lead and manage the team and develop staff in these vital new roles</li><li>Drive strategy and execution for the use of data sources in operational design and planning to improve predictability and speed of execution</li><li>Enable and support continued evolution of the Operational Design Lead and Operational Design Analytics roles</li><li>Partner with Clinical Program Managers to ensure consideration of innovative patient recruitment strategies and patient voice during operational design and planning</li><li>Partners with Global Network Leads and Business Process Owners to advance processes in support of the new capabilities and roles.</li><li>Collaborate with stakeholder functions including Center for Design and Analytics (CfDA) Data Sciences, CfDA Design & Innovation, Center for Observational Research and Global Development Operations leadership to identify new opportunity and findings to support planning and execution of clinical trials</li><li>Demonstrate external knowledge of industry standard methodologies, processes and new trends</li><li>Support introduction and scaling of significant operational innovations</li></ul><br><br>Basic Qualifications:<br><br>Doctorate degree and 4 years of Clinical experience<br><br>OR<br><br>Master's degree and 8 years of Clinical experience<br><br>OR<br><br>Bachelor's degree and 10 years of Clinical experience<br><br>Preferred Qualifications:<br><ul><li>M.D., D.O., PhD, PharmD, MSc</li><li>11+ years work experience in life sciences or medically related field, including 8+ years of biopharmaceutical clinical research experience obtained working in clinical development at a biotech, pharmaceutical or CRO</li><li>Strong understanding of operationalizing clinical development programs in a global setting</li><li>Experience with the implications of protocol design and operational planning on trial execution</li><li>Experience in using data and analytics to inform clinical trial planning and design</li><li>Expertise in clinical data sources and understanding of how and when to apply them</li><li>Experience with time, cost and quality metrics</li><li>Experience leading projects in a matrix organization</li><li>Experience in leading organizations through change</li><li>Proactive problem solving through innovative and pragmatic solutions</li><li>Previous management experience of direct reports</li><li>Experience in developing goals and training plans to improve talent and career development of staff</li></ul><br><br>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.<br><br>Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded teamwork, trust, empowerment and inclusion in all that we do.<br><br>We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.<br><br>Amgen focuses on areas of high unmet medical need and uses 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.<br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/7eOP1WIn1MKACZ1NF7Y5y"> <p>PI117640054</p>

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Posted: 2020-01-31 Expires: 2020-03-02

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Director, Operational Design

Amgen
Thousand Oaks, CA 91360

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