Director, Clinical Pharmacology, Modeling and Simulation

BioSpace; South San Francisco (CA); On-site; USD 300,000 - 360,000; Full time

Benefits offered by this job

Retirement plan

Group medical, dental and vision

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based long-term incentives

Award-winning time-off plans

Job summary

Amgen in South San Francisco, CA is seeking a Director of Clinical Pharmacology, Modeling & Simulation to lead the development and execution of strategies across modalities. You will design strategic clinical pharmacology plans, apply MIDD approaches, and guide PK/PD, PBPK and QSP studies to inform pivotal development decisions.

You will represent the department on global cross-functional teams, mentor scientists, and drive regulatory-ready study designs while advancing Amgen's pipeline with

Qualifications

• Doctorate degree with 4+ years' CPM&S experience.
• Masters degree with 8+ years' CPM&S experience.
• Bachelor's degree with 10+ years' CPM&S experience.
• At least 4 years of people management or leadership experience.

Responsibilities

• Develop and implement Clinical Pharmacology, Modeling & Simulation strategies across modalities.
• Design strategic clinical pharmacology plans integrated with development plans.
• Lead PK/PD, PBPK, and QSP modeling approaches to inform drug development.
• Represent the department on global cross-functional drug development teams.
• Apply Model-Informed Drug Development to ensure optimal dosing and trial design.

Skills

Leadership

Clinical Pharmacology

MIDD

PK/PD modeling

PBPK modeling

Regulatory science

Education

Doctorate degree

Master's degree

Bachelor's degree

Tools

PBPK modeling software

Quantitative PK/PD tools

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 worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Director, Clinical Pharmacology, Modeling and Simulation

What you will do

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.

Basic Qualifications

• Doctorate degree and 4 years of Clinical Pharmacology and Modeling & Simulation experience
• OR
• Masters degree and 8 years of Clinical Pharmacology and Modeling & Simulation experience
• OR
• Bachelors 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.

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, well 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.

Benefits and Rewards

• 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.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

In any materials you submit

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.

Equal Opportunity and Inclusion

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.