Senior Manager Development Operations

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Manager Development Operations

What you will do

Let’s do this. Let’s change the world. In this vital role you will:

LATAM hub leader of Global Study Operations / Site Management (GSO-SM) organization that is accountable for overall country/hub delivery across studies. in Argentina, Brazil, Chile,  Colombia, Mexico and Peru.

This role will develop and drive innovative strategies to promote an optimal clinical research environment in the hub and will actively partners with cross-functional stakeholders to support Amgen and R&D strategies

Leadership of GSO-SM team in country/hub

• Align and lead country /hub in accordance with Amgen strategy, driving «One Amgen»
• Maintain knowledge of country/hub capabilities and clinical research best practices.
• Represent GSO-SM in internal and external partner interactions.
• Establish and drive local engagement strategy in coordination with local partners to optimize external engagements (e.g. key targeted sites, Patient Advocacy groups, Pharma Associations, Consortium's)
• Advocate for local study placement strategy in consideration of country/hub strengths and growth opportunities.
• Drive process excellence, innovation and continuous improvement to accelerate study portfolio delivery.
• Support and/or lead local and global process improvement & transformational initiatives.
• Embrace and be an advocate for change within local and global teams.
• Locally accountable for overall country delivery across studies.
• Shape and foster internal environment for optimal local cluster team collaboration.
• Monitor overall health and consistency of local cluster teams interactions to enable successful delivery of pipeline molecule programs.
• Partner with relevant Global Development Operations (GDO) functions to monitor study progress and drive timely local action plans & issue resolution.
• Point for escalation for resolution of clinical study related issues & risks which impact delivery or quality of clinical trials and/or patient safety.
• Accountable for country/hub landscaping activities and operational projections.
• Required advisor for site selection and country commitments.
• Ensure timely communication with cross-functional teams to support clinical study execution.
• Support ISSs execution & partner with medical to design and execute local Amgen sponsored trials.
• Performance management of local staff and oversight of GSO-SM Functional Service Provider(s) (FSP) and other local vendors.
• Partner with RH to maintain appropriate resource levels and manage within budget.
• Interpret resource supply and demand and ensure efficient resource allocation.
• Risk mitigation and quality management.
• Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness.
• Interpret analytics to supervise overall country delivery across studies (timelines, enrollment, data flow, TMF)
• Oversee quality and ensure country/hub deliverables in accordance with ICH-GCP, Amgen standards and Local Regulations.
• Support internal/affiliate and site audits and regulatory inspections and drive local CAPA implementation.

Decision-Making Authority

• Local GSO-SM budget and resourcing.
• Staff recruiting, mentor, development and talent reviews.
• Risk mitigation, issue management and escalations
• Local FSP management decisions (including FMT)
• Local (GSO-SM) SME development.
• Financial sign off within grade parameters.

Outputs

• Overall country study delivery across studies (timelines, enrollment, data flow, TMF)
• Local GSO-SM goals.
• Local GSO-SM resourcing strategy.
• Country cross-functional meetings/reviews.
• Resource, planning and capacity management.
• Local external engagement plans.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Master’s degree & 5 years of directly-related clinical experience OR
• Bachelor’s degree (BA/BS/BSc or RN) & 7 years of directly-related clinical experience OR
• Associate’s degree & 10 years of directly related clinical experience AND
• Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
• Previous management experience of direct reports, including management level staff.
• Fluency in English.

Preferred Qualifications:

• M.D., D.O., PhD, PharmD, Master’s Degree.
• 7 years work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
• Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
• Country clinical operations experience and/or regional study management experience.
• Sophisticated knowledge of global clinical trial management.
• Clinical trial processes and operations.
• In depth understanding of drug development process, clinical trial conduct, ICH-GCP and local regulations, requirements, and guidelines.
• Project and Program management including oversight of quality, study results, budgets and timelines.
• Various therapeutic area knowledge.
• Clinical trial management systems and reporting tools.
• Fluency in Spanish.

Competencies

• Commitment to uphold ethics and the Amgen values.
• Ability to work independently as well as in a team/matrix environment on multiple projects and countries.
• Analytical, Decision making and problem solving skills.
• People and performance management.
• Oral and written communication skills.
• Strategic operational planning and cross-functional leadership
• Horizon scanning.
• Risk assessment and risk mitigation.
• Issue management and customer concern.
• Project management.
• Organizational skills: planning, time management, prioritization, delegation.
• Teamwork, collaboration and relationship building skills across geographic areas, including: networking, negotiation and influencing skills across all levels with both internal/external partners.
• Change management skills and learning ability.
• Patience, flexibility and high tolerance for ambiguity and change.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.