Sr. Principal Scientist - Clinical Pharmacology Study Lead

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.

Sr. Principal Scientist - Clinical Pharmacology Study Lead

What you will do

Let’s do this. Let’s change the world! Let’s do this. Let’s change the world. In this vital and unique role for a nurse practitioner you will be a member of the Clinical Pharmacology, Modeling & Simulation department. You will lead the execution 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. You 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 expert to provide clinical/scientific knowledge for the development and execution 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%.

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 leader with these qualifications.

Basic Qualifications:

Doctorate degree (PhD or DNP) OR PharmD OR MD and 2 years of Safety/Pharmacovigilance or Clinical Research experience in a hospital, university or clinical research unit setting

Or

Master’s degree (MSN) and 4 years of Safety/Pharmacovigilance or Clinical Research experience in a hospital, university or clinical research unit setting

Or

Bachelor’s degree (BSN) and 6 years of Safety/Pharmacovigilance or Clinical Research experience in a hospital, university or clinical research unit setting

Or

Associate’s degree (ADN) and 10 years of Safety/Pharmacovigilance or Clinical Research experience in a hospital, university or clinical research unit setting

Or

High school diploma / GED and LVN and 12 years of Safety/Pharmacovigilance or Clinical Research experience in a hospital, university or clinical research unit setting experience

Preferred Qualifications:

• Nurse practitioner with PhD and/or