27 days old

Executive Director, Combination Product Safety Head

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117665967
Amgen

Job ID: R-92155
Location: Thousand Oaks, CA, US 91360

The Combination Product Safety Head leads the Combination Product Safety group in fulfilling its primary responsibilities to include the assessment of potential impact of quality findings on patient/user safety for all clinical and commercial products, supporting the review by Global Safety Officers of adverse event data to detect potential product quality issues for commercial products as well as managing the provision of expertise for Combination Product safety data collection/analysis/reporting and the provision of expertise for device/ Combination Product risk management activities.

This position is located in Thousand Oaks, California.

Responsibilities include:
  • Drives the execution of strategic and pharmacovigilance process-related activities required to support the development and maintenance of the clinical development and post marketing safety of Devices and Drug-Device Combinations
  • Ensures Global Patient Safety (especially Therapeutic Area Safety) meet with Product Quality functions to review AE and Product Complaints (both sentinel cases and aggregate) on a regular basis
  • Support cross functional teams in pharmacovigilance compliance
  • Supports Global Safety Officer in the authoring of Medical Opinion Memos and Health Hazard Evaluations and User Risk Assessments
  • Responsible for effective and timely implementation of new Combination Product and pharmacovigilance and vigilance (post market) best practices
  • Assures use of best practices in Combination Product/Devices benefit-risk assessments
  • Interfaces with internal and external functions in projects and governance committees as appropriate
  • Maintains a high-level view of all of the Combination Product and diagnostics projects that the organization is undertaking or considering undertaking
  • Supports the sharing of learnings in Devices/Combination Product/Diagnostics knowledge
  • Monitors/understands changes in the regulatory area, defines implications for Amgen and converts to actionable program activities.
  • Makes decisions using clinical knowledge
  • Utilizes knowledge of integrated body systems' pathophysiology to evaluate the impact of device/drug-device issues (e.g. malfunction)
  • Oversee Combination Product Safety group compliance with Amgen internal metrics (e.g., KCIs)
  • Ensures readiness of direct reports for Inspections
  • Supports Inspection readiness across GPS
  • Undertakes activities delegated by the EU QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
  • Acts as representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
  • Performs management activities for direct reports including mentoring, career development, training, etc.
  • Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor


Basic Qualifications:
  • MD or DO degree from an accredited medical school and 6 years of related work experience AND Completion of an accredited medical or surgical residency OR
  • Clinical experience in either an accredited academic setting or private practice (including hospital based setting) AND
  • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources


Preferred Qualifications:
  • 3 years+ experience with device/combination product development including safety/risk management
  • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
  • Knowledge of global regulatory requirements, standards, and guidance for safety/risk management in relation to product quality issues, combination products, standalone devices, and diagnostics
  • Understanding of device risk management methodology, tools, and terminology, including human factors engineering methodology
  • Familiarity with cGMP requirements and processes for drugs/biologics and devices/combination products
  • Addition skills to include: decision making and prioritization, ability to work cross functionally with an emphasis on teamwork and collaboration, knowledge of regulatory interpretation and clinical case assessments

Consistent with our core leadership value of "Develops the Best Team," we are seeking leaders that prioritize the development of talent. As a manager, your first priority and primary role is to accelerate the performance and development of your team. We expect managers to exemplify strong leadership and champion self-awareness and career development. Ways that you will display your leadership acumen in this role include:
  • Mentoring, coaching, and developing staff to build highly-skilled, diverse, and inclusive teams
  • Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities
  • Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business
  • Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement
  • Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages
  • Developing an understanding of your team's career objectives and serve as a thought-partner in their career development plans
  • Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives
  • Resolving critical gaps in the organization's internal capabilities and skillsets, including strategic external recruiting
  • Identifying diverse, qualified successors for key positions
  • Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff


At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our "people-first" philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

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.

PI117665967

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92155<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Combination Product Safety Head leads the Combination Product Safety group in fulfilling its primary responsibilities to include the assessment of potential impact of quality findings on patient/user safety for all clinical and commercial products, supporting the review by Global Safety Officers of adverse event data to detect potential product quality issues for commercial products as well as managing the provision of expertise for Combination Product safety data collection/analysis/reporting and the provision of expertise for device/ Combination Product risk management activities.<br><br>This position is located in Thousand Oaks, California.<br><br><b>Responsibilities include</b>:<br><ul><li>Drives the execution of strategic and pharmacovigilance process-related activities required to support the development and maintenance of the clinical development and post marketing safety of Devices and Drug-Device Combinations</li><li>Ensures Global Patient Safety (especially Therapeutic Area Safety) meet with Product Quality functions to review AE and Product Complaints (both sentinel cases and aggregate) on a regular basis</li><li>Support cross functional teams in pharmacovigilance compliance</li><li>Supports Global Safety Officer in the authoring of Medical Opinion Memos and Health Hazard Evaluations and User Risk Assessments</li><li>Responsible for effective and timely implementation of new Combination Product and pharmacovigilance and vigilance (post market) best practices</li><li>Assures use of best practices in Combination Product/Devices benefit-risk assessments</li><li>Interfaces with internal and external functions in projects and governance committees as appropriate</li><li>Maintains a high-level view of all of the Combination Product and diagnostics projects that the organization is undertaking or considering undertaking</li><li>Supports the sharing of learnings in Devices/Combination Product/Diagnostics knowledge</li><li>Monitors/understands changes in the regulatory area, defines implications for Amgen and converts to actionable program activities.</li><li>Makes decisions using clinical knowledge</li><li>Utilizes knowledge of integrated body systems' pathophysiology to evaluate the impact of device/drug-device issues (e.g. malfunction)</li><li>Oversee Combination Product Safety group compliance with Amgen internal metrics (e.g., KCIs)</li><li>Ensures readiness of direct reports for Inspections</li><li>Supports Inspection readiness across GPS</li><li>Undertakes activities delegated by the EU QPPV as detailed in the PV System Master File and maintain a state of inspection readiness</li><li>Acts as representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility</li><li>Performs management activities for direct reports including mentoring, career development, training, etc.</li><li>Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor</li></ul><br><br><b>Basic Qualifications:</b><br><ul><li>MD or DO degree from an accredited medical school and 6 years of related work experience AND Completion of an accredited medical or surgical residency OR</li><li>Clinical experience in either an accredited academic setting or private practice (including hospital based setting) AND</li><li>6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources</li></ul><br><br><b>Preferred Qualifications:</b><br><ul><li>3 years+ experience with device/combination product development including safety/risk management</li><li>6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources</li><li>Knowledge of global regulatory requirements, standards, and guidance for safety/risk management in relation to product quality issues, combination products, standalone devices, and diagnostics</li><li>Understanding of device risk management methodology, tools, and terminology, including human factors engineering methodology</li><li>Familiarity with cGMP requirements and processes for drugs/biologics and devices/combination products</li><li>Addition skills to include: decision making and prioritization, ability to work cross functionally with an emphasis on teamwork and collaboration, knowledge of regulatory interpretation and clinical case assessments<br></li></ul><br>Consistent with our core leadership value of "Develops the Best Team," we are seeking leaders that prioritize the development of talent. As a manager, your first priority and primary role is to accelerate the performance and development of your team. We expect managers to exemplify strong leadership and champion self-awareness and career development. Ways that you will display your leadership acumen in this role include:<br><ul><li>Mentoring, coaching, and developing staff to build highly-skilled, diverse, and inclusive teams</li><li>Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities</li><li>Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business</li><li>Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement</li><li>Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages</li><li>Developing an understanding of your team's career objectives and serve as a thought-partner in their career development plans</li><li>Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives</li><li>Resolving critical gaps in the organization's internal capabilities and skillsets, including strategic external recruiting</li><li>Identifying diverse, qualified successors for key positions</li><li>Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff</li></ul><br><br>At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our "people-first" philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.<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/2VleyKHWEbokTZVPFDBKj"> <p>PI117665967</p>

Categories

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

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Executive Director, Combination Product Safety Head

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast