5 days old

Global Clinical Program Mgt Senior Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115291556
Amgen

Job ID: R-87314
Location: Thousand Oaks, CA, US 91360

The Senior Manager supports the Global Clinical Program Management Director in overseeing the planning and execution of all studies for the program (accountable for all studies in the program if no director level present)

Responsibilities:
  • Global clinical program operational strategy and planning, program/study risk assessment and mitigation, and overall execution of clinical trials on time and within budget
  • Provide clinical operations leadership and expertise on the Evidence Generation Team and in development of the Evidence Generation Plan providing input into product global and regional evidence generation plans (product level)
  • Maintain global business relationships cross-functionally and communicating program strategy and deliverables of clinical trial programs to senior management and key stakeholders
  • Functional oversight of Global and Regional Clinical Trial Managers and collaboration with People and Resources Manager on performance management
  • Initiate and support conduct of Country Operational Landscape Assessments and Targeted Local Feasibility in collaboration with cross functional roles
  • Development and oversight of clinical program budgets including change control in collaboration with Therapeutic Area and Finance
  • Contribute operational expertise throughout protocol design sessions coordinating cross functional input on a continuous basis
  • Support / accountable for study global enrolment and accurate global recruitment forecasting, and implement and measure the success of subject recruitment and retention strategies
  • Identify outsourcing requirements at a study / program level and oversee the identification, set-up, and management of CROs and vendors; may represent GCPM at Vendor Operational Management Teams; contribute to capability assessments for new vendors and participate in vendor qualification assessments
  • Support and oversee internal audit, inspection activities, contribute to CAPAs globally for the program and lead planning for regulatory agency inspection readiness activities (e.g. TMF review)
  • Represent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and execution ; Contribute to development and maintenance of policies, SOPs and associated documents
  • Facilitate sharing of best practices and product knowledge within the function


Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 2 years of Clinical experience

OR

Bachelor's Degree and 4 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 life science, computer science, business administration or related discipline

7+ years work experience in Global Clinical Trials Management

3+ years project management and planning experience

Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, etc.)

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 collaboration, trust, empowerment and inclusion in all that we do.

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.

Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.

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.

PI115291556

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87314<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Senior Manager supports the Global Clinical Program Management Director in overseeing the planning and execution of all studies for the program (accountable for all studies in the program if no director level present)<br><br>Responsibilities:<br><ul><li>Global clinical program operational strategy and planning, program/study risk assessment and mitigation, and overall execution of clinical trials on time and within budget</li><li>Provide clinical operations leadership and expertise on the Evidence Generation Team and in development of the Evidence Generation Plan providing input into product global and regional evidence generation plans (product level)</li><li>Maintain global business relationships cross-functionally and communicating program strategy and deliverables of clinical trial programs to senior management and key stakeholders</li><li>Functional oversight of Global and Regional Clinical Trial Managers and collaboration with People and Resources Manager on performance management</li><li>Initiate and support conduct of Country Operational Landscape Assessments and Targeted Local Feasibility in collaboration with cross functional roles</li><li>Development and oversight of clinical program budgets including change control in collaboration with Therapeutic Area and Finance</li><li>Contribute operational expertise throughout protocol design sessions coordinating cross functional input on a continuous basis</li><li>Support / accountable for study global enrolment and accurate global recruitment forecasting, and implement and measure the success of subject recruitment and retention strategies</li><li>Identify outsourcing requirements at a study / program level and oversee the identification, set-up, and management of CROs and vendors; may represent GCPM at Vendor Operational Management Teams; contribute to capability assessments for new vendors and participate in vendor qualification assessments</li><li>Support and oversee internal audit, inspection activities, contribute to CAPAs globally for the program and lead planning for regulatory agency inspection readiness activities (e.g. TMF review)</li><li>Represent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and execution ; Contribute to development and maintenance of policies, SOPs and associated documents</li><li>Facilitate sharing of best practices and product knowledge within the function</li></ul><br><br>Basic Qualifications:<br><br>Doctorate Degree <br><br> OR <br><br> Master's Degree and 2 years of Clinical experience <br><br> OR <br><br> Bachelor's Degree and 4 years of Clinical experience <br><br> OR <br><br> Associate's degree and 10 years of Clinical experience <br><br>OR<br><br>High school diploma / GED and 12 years of Clinical experience<br><br>Preferred Qualifications:<br><br>Master's degree in life science, computer science, business administration or related discipline <br><br> 7+ years work experience in Global Clinical Trials Management <br><br> 3+ years project management and planning experience <br><br> Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, etc.) <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 collaboration, trust, empowerment and inclusion in all that we do.<br><br>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.<br><br>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. <br><br>Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.<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/E5dDp4CDxnwVuY5bsXman"> <p>PI115291556</p>

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Posted: 2019-11-08 Expires: 2019-12-09

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Global Clinical Program Mgt Senior Manager

Amgen
Thousand Oaks, CA 91360

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