13 days old

Executive Director - Global Study Operations

Thousand Oaks, CA 91360
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  • Job Code

Job ID: R-113212
Location: Thousand Oaks, CA, US


    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.

    The Executive Director, Global Study Operations


    What you will do

    Let's do this. Let's change the world. In this vital role as Executive Director, Global Study Operations (GSO) 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 (Phase 1-4, all therapeutic areas) as well as build and develop a high performing GSO team and engage and align internal and Functional Service Provider (FSP) staff with the Company's strategy and priorities. Amgen executes clinical trials in more than 50 countries across all regions.

    You will be responsible for functional vision and strategy and vendor oversight. You will contribute to Global Development Operations (GDO) leadership and drive innovation and ongoing continuous improvement. You will be responsible for operational oversight, managing a functional department of data managers, project management staff with site and data management backgrounds, and local affiliate support for studies. You will also oversee FSP partnerships to ensure the delivery of quality and cost-efficient benefits in addition to managing resourcing within the GSO and mentoring and developing staff. The Executive Director will maintain close collaboration with Global Clinical Program Management (GCPM) in alignment with Development priorities and build strategic partnerships and collaboration with cross functional teams.

    Primary Responsibilities:
  • Provide global vision and strategic leadership for GSO including Site Management and Data Management
  • Ensure GSO Operating Reviews are held
    • Identify issues and assist staff in their resolution
    • Communicate escalation of issues to executive management
  • Promote innovation that 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 SOP's 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 ~50 countries; this includes direct staff of >100 and indirect staff of up to 1,400
  • 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 and establishing succession plans
  • Ability to travel up to 50% of the time globally
  • Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The GSO professional we seek is a Leader with these qualifications.

    Basic Qualifications
  • Doctorate degree and 6 years of Clinical Operations experience OR
  • Master's degree and 10 years of Clinical Operations experience OR
  • Bachelor's degree and 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
  • Masters or higher degree in quantitative or scientific subjects
  • 12 or more years of relevant experience in a Clinical Development environment delivering in a broad range of therapeutic areas
  • 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 is required
  • Experience overseeing outsourced partnerships
  • In depth knowledge of clinical trials research and drug development processes to include delivery of innovative/adaptive design trials and understanding the complexities on processes, enrollment and regulatory interactions
  • Thorough understanding of industry regulations, trends in standards and the implementation
  • Regulatory submission experience including advisory committees and reimbursement as well as support of inspection activities
  • Leadership and management skills within Clinical Development
  • Proven organizational and technical expertise
  • Broad knowledge of project and resource management practices in the pharmaceutical industry
  • Leadership tool sets required to drive organizational change (e.g. lean principles)
  • Experience managing in a matrix and understanding cultural differences for leading Affiliates
  • Thrive

    What you can expect of us

    As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
  • Amgen's 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.

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

    MEANINGFUL IMPACT. To serve patients. We are all deeply committed to our mission: to serve patients. And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose.

    INNOVATIVE: Stretch yourself at the cutting edge. You're poised to have a high impact in the new Bio century, Amgen offers our people interesting and challenging work.

    REPUTATION. Be behind world-renowned products and services. With our industry reputation and strong product pipeline, you can take pride in working at Amgen.

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

    REWARDING. Get a fair share in success. Everyone's contribution is recognized - and strong performance is rewarded.

    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.

    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.

Posted: 2021-02-20 Expires: 2021-03-24

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Executive Director - Global Study Operations

Thousand Oaks, CA 91360

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