Compliance Sr. Director U.S. Rare Disease

Career Category

Job Description

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.

Compliance Sr. Director U.S. Rare Disease

What you will do

Let’s do this. Let’s change the world. In this vital role The WC&BE Sr. Director, Rare Disease, will be responsible for upholding the reputation of Amgen and driving ethical solutions for the patients we serve.

Reporting to the Associate Vice President of Compliance, this position will serve as the primary compliance business partner for the Amgen Rare Disease Business Unit, leading a team that works closely with that organization's leadership to maintain a strong culture of compliance, integrity, and ethics.

This position would ideally sit in proximity to either our Thousand Oaks, CA or Deerfield, IL office or U.S. remote.

In this role, you will need to:

• Drive solutions that empower our colleagues to elevate ethical decision-making and honorably secure patient access for our current and future patients

• Proactively support and anticipate business needs by embedding in both the senior leadership team and their individual leadership teams

• Develop multi-dimensional compliance strategies tailored to the unique circumstances and needs of each RDBU business that incorporate learnings from monitoring, investigations, business engagement and industry actions

• Harness purposeful relationship building and develop trust to engender buy-in with leaders by developing rapport, participating, listening and learning

• Possess unique understanding of the rare landscape and regulatory environment to thoughtfully and open-mindedly advise the Rare Disease Business Unit

• Lead and develop a team of compliance officers to elevate the support of the business

• Embrace ambiguity and adeptly navigate the evolving risk paradigm with agility, confidence and intentionality

• Influence within WC&BE and across RDBU and cross-functional partners to facilitate collaborative decision-making that elevates and ethically meets patient needs

• Confidently problem-solve, including knowing when to escalate potential challenges, and quickly learn how to work within a matrixed organization

• Be prepared to travel to major conferences, internal trainings and meetings for WC&BE or RDBU, as well as to Amgen sites in the U.S. or globally

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The compliance professional we seek will meet these qualifications.

Basic Qualifications:

Doctorate degree and 5 years of compliance, legal or a control function supporting a bio-pharmaceutical business experience

Or

Master’s degree and 8 years of compliance, legal or a control function supporting a bio-pharmaceutical business experience

Or

Bachelor’s degree and 10 years of compliance, legal or a control function supporting a bio-pharmaceutical business experience

Preferred Qualifications:

• five years of experience with buy-and-bill and/or patient support services model

• Prior experience as the lead strategic compliance or legal advisor for a bio-pharmaceutical medicine

• Deep understanding of the biotechnology industry and healthcare compliance environment (US required, plus additional major markets preferred)

• Experience navigating drug approvals, data milestones and regulatory decisions

• Preference for candidates with experience supporting rare disease medicines

• Demonstrated skills in delivering strategies and results in a complex organization

• Ability to prioritize resources and effectively communicate with leadership

• Appreciation of nuanced, regulated and confidenti