Associate Vice President, Global Study Operations

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Associate Vice President, Global Study Operations (GSO)

Live

What you will do

Lets do this. Lets change the world. In this vital AVP role you will be accountable for the leadership and oversight of the GSO Site Management and Data Management organizations.

You will ensure excellence and consistency in clinical trial execution across the portfolio; build and develop a high performing GSO team and engage and align internal and Functional Service Provider (FSP) staff with Amgen strategy and priorities.

In this position, you will be responsible for functional vision and strategy and vendor oversight. Contributing to Global Development Operations (GDO) leadership Senior Team and driving innovation and ongoing continuous improvement.

You will also be responsible for operational oversight, managing a functional department of outsourced data managers, technical staff and site managers for Amgen-sponsored clinical studies across all Therapeutic Areas and phases; overseeing FSP partnerships that deliver quality and cost-efficient benefits; manage resourcing within GSO and mentoring staff and ensuring staff development.

You will maintain close collaboration with Clinical Program Operations (CPO) in alignment with Development priorities and build strategic partnerships and collaboration with cross functional teams.

The AVP reports to the Vice President Global Development Operations. This position can be located in Thousand Oaks, CA or remotely in the United States.

Responsibilities

• Provide global vision and strategic leadership for GSO including Site Management, Data Management (Therapeutic Areas (TAs))

• Ensure GSO Operating Reviews are held in Amgen Affiliates

• Identify issues and assist staff in their resolution

• Communicate escalation of issues to management

• Promotes innovation and supports global and functional initiatives where appropriate including global alignment within GSO, GDO and Therapeutic Areas

• Serve as a Point of Contact for the function during regulatory inspections and follow-up inspection commitments

• Accountable for selection and leadership of FSP vendors supporting monitoring, systems and data management therapeutic area activities

• Oversee study and systems audits by internal and external bodies, and respond to audit questions and findings

• Provide management authority and input to the development and review of GSO SOPs and other controlled documents

• Lead strategic resource management planning that enables high-performing staff utilization targets

• Provide resource and budget oversight at functional level

• Provide leadership on partnering and outsourcing strategies

• Set annual departmental goals and lead in their achievement

• Provide ongoing leadership in staff career development

• Manage staff performance and oversee assignments and utilization for the function covering ~60 countries

• Accountable for managing a global budget of approximately $380m

• Work cross-functionally to establish and maintain priorities on projects impacting the function

• Recognize and promote innovation

• Recruit and develop departmental staff through mentoring and developing departmental staff/establishing succession plans

• Strong data and analytical skills are necessary given the evolving environment and application of Artificial Intelligence and Machine Learning capabilities.

• Ability to travel up to 15-20% of time

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The AVP Global Study Operations we seek is an experienced leader with the following qualifications.

Basic Qualifications:

• Doctorate degree & 6 years of Clinical Operations experience OR

• Masters degree & 10 years of Clinical Operations experience OR

• Bachelors degree & 12 years of Clinical Operations experience 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:

• MSc or higher degree in quantitative or scientific subjects

• 12 or more years of relevant experience in a clinical development environment

• Experience working effectively in a globally dispersed team environment with cross-cultural partners

• Oral and written communication skills

• Negotiation skills

• Prior staff development, leadership, and project management experience

• Experience of overseeing FSP partnerships

• In-depth knowledge of clinical trials research and drug development experience

• Thorough understanding of industry trends in standards and their implementation

• Regulatory submission experience including advisory committees and reimbursement

• Strong leadership and management skills within clinical development

• Extensive experience with external staffing providers

• Experience managing a large and diverse organization

• Organizational and technical expertise

• Deep understanding of drug development process and clinical trials

• Broad knowledge of project and resource management practices in the pharmaceutical industry

• General therapeutic area knowledge

• Leadership toolsets required to drive organizational change (e.g. lean principles)

• Understanding of regulations governing clinical trials analysis and reporting

• Experience interacting with inspectorates worldwide

• Experience managing in a matrix and understanding cultural differences for leading Affiliates

They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Thrive

What you can expect of us

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

The annual base salary range for this opportunity in the U.S. is $286,233 - $334,445.00.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Amgens Commitment to Our 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.

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 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 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 accommodation.