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Associate Vice President, Global Study Operations

4 months ago

Thousand Oaks, United States Amgen Full time

**HOW MIGHT YOU DEFY IMAGINATION?**

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s 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**

Let’s do this. Let’s 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
- 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
- Master’s degree & 10 years of Clinical Operations experience OR
- Bachelor’s 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**:

- 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 re