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 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.
• Desire to develop skills in design of clinical pharmacology studies, pharmacokinetic and pharmacokinetic/pharmacodynamic strategies, data analysis, and interpretation of data from clinical studies.
• Desire to develop drug-development expertise and represent the clinical pharmacology department on cross-functional drug development teams.

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.

Salary Range