Director, Clinical Pharmacology, Modeling and Simulation

Let’s do this. Let’s change the world. The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Director at its South San Francisco, CA location. In this vital role you will be responsible for the development and implementation of the Clinical Pharmacology, Modeling & Simulations strategies for the industry leading cutting-edge pipeline of most innovative therapeutic modalities. Amgen’s robust pipeline leverages state-of-the-art science and molecular engineering focused on the pursuit of transformative medicines with large effects in serious diseases. 

The Director, Clinical Pharmacology, Modeling & Simulation will be a leader in the field of clinical pharmacology and a Subject Matter Expert. You will be an expert in designing strategic clinical pharmacology, modeling & simulations plans integrated with clinical development plans in support of new drug development across modalities. You will have expertise in designing clinical pharmacology and biopharmaceutic studies. You will be an expert in clinical drug development and will apply Model-Informed Drug Development (MIDD) strategies and approaches together with principles of quantitative clinical pharmacology to ensure optimal drug development. You will represent the Clinical Pharmacology, Modeling & Simulation Department at the global cross-functional drug development teams. You will apply innovative Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches and clinical pharmacology strategies and principles to guide optimal drug development across early to late-stage development programs. Your expertise will include application of Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling, and Quantitative Systems Pharmacology (QSP) modeling to new drug development to ensure development of safe & effective dosing regimens for various patient sub-populations & ensure optimal new drug development.

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 and 4 years of Clinical Pharmacology and Modeling & Simulation experience

OR

Master’s degree and 8 years of Clinical Pharmacology and Modeling & Simulation experience

OR

Bachelor’s degree and 10 years of Clinical Pharmacology and Modeling & Simulation experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or equivalent professional degrees e.g. MD, PharmD).

• 8+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.

• Established track-record of designing strategic clinical pharmacology, modeling & simulations plans in support of new drug development across modalities.

• Experience in leading the design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.

• Established track-record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance

• Hands-on experience in Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches with a focus on Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling to inform clinical study designs for drug-drug interaction, special population, ethnic sensitivity, pediatric and biopharmaceutics studies. Expert knowledge of commonly used software for PBPK modeling required.

• Established track-record of Model Based Drug Development.

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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship for this role is not guaranteed.

Salary Range