Digital Medicines Study Operations Director

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.

Digital Medicines Study Operations Director

What you will do

Let’s do this. Let’s change the world. In this vital role you will play a critical leadership role in driving the design, planning, and execution of digitally enabled clinical studies. This includes decentralized trial components, pragmatic study designs, and the integration of digital health tools and platforms. The Director will ensure that operational strategies, processes, and governance frameworks support the efficient and compliant delivery of digital medicine studies that enhance patient participation, data quality, and trial efficiency that will lead faster evidence generation.

As a key partner to the Digital Innovation Research team, this role will beresponsible for operational planning of digital medicine studies from the concept development stage through study team formation. The Director will collaborate closely with study teams to ensure seamless integration of digital elements into study KDE and protocol.

The role willlead efforts to shorten Digital Medicine study timelines by identifying barriers and providing solutions for process and governance improvements in close collaboration with clinical program management, global strategic resourcing and other partners.

The role requires strong expertise in clinical program management, digital health strategy, and cross-functional leadership to drive innovation while ensuring compliance, feasibility, and patient-centricity.

Responsibilities

• Lead operational planning for digital medicine studies at the concept development stage, ensuring feasibility and alignment with Amgen SOP and capabilities.

• Collaborate with Digital Innovation Research, Medical, and Clinical Operations to identify fit-for studies for digital enablement.

• Provide operational input into study designs, focusing on digital, decentralized, and pragmatic trial elements.

• Find opportunities to reduce reliance on external vendors by strengthening Amgen’s internal digital infrastructure and capabilities.

• Partner with related functions to design, improve and scale PARC platform to support digital medicine studies

• Drive the development of fit-for-purpose digital solutions (e.g., patient engagement platforms, data capture systems, wearable integration frameworks) that can be demonstrated enterprise-wide

• Serve as the primary digital medicines operational partner in study team, ensuring smooth transition from concept to execution.

• Advise on the selection, validation, and implementation of digital tools, wearables, remote monitoring technologies, and digital endpoints.

• Lead initiatives to shorten digital medicine study timelines by streamlining workflows and removing operational bottlenecks

• Establish and implement standards, templates, and tools for operational planning of digital studies

• Develop KPIs and monitoring frameworks to track progress and ensure accountability across study teams.

• Actively monitor the external digital health environment, identifying emerging technologies, tools, and methods relevant to decentralized and pragmatic trials.

• Build and maintain relationships with vendors, CROs, and technology providers, ensuring alignment on capabilities, timelines, and quality standards for studies.

• Partner with Global Strategic Sourcing to assess vendor fit-for-purpose solutions and negotiate effective partnerships.

• Build, lead and develop a successful Digital Medicines Operational Planning Team

• Lead change management to drive cultural and organizational adoption of innovative research methods

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 4 years of relevant experience OR

• Master’s degree and 7 years of relevant experience OR

• Bachelor’s degree and 9 years of relevant experience

Preferred Qualifications:

• Advanced degree in life sciences, medicine, pharmacy, public health, or related field (PhD, MD, PharmD, or MSc preferred).

• 10+ years of experience in clinical research, clinical operations, or digital health within pharma/biotech, CRO, or digital medicine organizations.

• Consistent track record in operational planning and execution of decentralized and/or pragmatic clinical trials

• Deep understanding of clinical trial operations, regulatory requirements, and digital health technologies.

• Strong communication and stakeholder management skills; ability to influence across levels and functions.

• Entrepreneurial mindset, with a strong focus on innovation, patient-centricity, and data-driven decision-making.

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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

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

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

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.