HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Scientific Associate Director - Clinical Pharmacology Study Lead

Live

What you will do

Let’s do this. Let’s change the world! In this vital and unique role for a nurse practitioner in the Clinical Pharmacology, Modeling & Simulation department. The Scientific Associate Director will lead the implementation of clinical pharmacology studies including bioequivalence, special safety, food-effect, drug-drug interaction, special population, ethnic sensitivity, Absorption, Distribution, Metabolization, and Excretion (ADME) in adult healthy volunteer and patient populations, in addition to pediatrics, to support a diverse pipeline. The qualified professional will also have the opportunity to develop pharmacokinetic (PK) and PK pharmacodynamic (PD) skills, gain drug-development experience, and represent clinical pharmacology in cross-functional drug development teams.

Responsibilities:

• Serve as clinical and subject matter authority to provide clinical/scientific knowledge for the development and implementation of clinical pharmacology trials across multiple therapeutic areas.
• Understand relevant health authority guidance and medical/scientific literature applicable to the design of various clinical pharmacology trials to ensure high quality study design, consistent with health authority requirements.
• Understand mechanism of action, preclinical and early phase safety data, and other compound-specific details within the Investigator Brochure; translate this information to design of clinical pharmacology trials across multiple therapeutic areas.
• Provide clinical input related to inclusion/exclusion criteria, clinical laboratory and other safety monitoring procedures, liaise with Safety Officers, and synthesize and communicate clinical information related to safety events on clinical pharmacology trials across therapeutic areas.
• Participate in the review of key clinical pharmacology trial documents such synopses, protocols, statistical analysis plans, tables, figures and listings, clinical study reports, and publications.
• Participate in site initiation visits, clinical study team, and ad hoc meetings to support successful conduct of clinical pharmacology studies across therapeutic areas.
• Collaborate with the clinical operations, medical monitoring, and clinical research unit site investigators to respond to clinical questions throughout the conduct of clinical pharmacology trials.
• Provide interpretation of safety, PK and PD data.
• Evaluate prospective clinical trial sites for upcoming clinical pharmacology trials.
• Travel 5 - 10%.

Win

What we expect of you

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

Basic Qualifications:

Doctorate and 4 years of Safety/Pharmacovigilance or Clinical Research experience in a hospital, university or clinical research unit setting

Or

Master's degree and 7 Years of Safety/Pharmacovigilance in the pharmaceutical or Clinical Research experience in a hospital, university or clinical research unit setting

Or

Bachelor's degree and 9 years of Safety/Pharmacovigilance in the pharmaceutical or Clinical Research experience in a hospital, university or clinical research unit setting

And

Broad knowledge of leading and / or innovative principles and theories in subject area and basic knowledge of related and adjacent disciplinary areas

And

Understands broader organizational goals and business priorities in relation to therapeutic program / work group

Preferred Qualifications:

• Advanced Practice Nurse (Nurse Practitioner or Nurse Anesthetist) with PhD and/or principal, co-investigator or sub-investigator experience.
• Experience in an acute care hospital or clinical research unit setting including clinical management of patients/clinical trial participants and participation in multidisciplinary patient rounds if applicable.
• Desires to develop skills in design of clinical pharmacology studies, pharmacokinetic and pharmacokinetic/pharmacodynamic strategies, data analysis, and interpretation of data from clinical studies.
• Motivated to develop drug-development expertise and represent the clinical pharmacology department on cross-functional drug development teams.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.