Hiring.Camp

Senior Director of Quantitative Pharmacology Modeling & Simulation

Amgen is committed to unlocking

·

2 days ago

Location
US - California - Thousand Oaks, United States of America · US - California - South San Francisco
Workplace
Hybrid
Type
Full-time
Seniority
Director
Experience
5+ years
Education
PhD
Source
Workday

Description

Career Category

Research

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. 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.

Senior Director of Quantitative Pharmacology Modeling & Simulation

What you will do

Let’s do this. Let’s change the world. This position in Quantitative Pharmacology Modeling & Simulation will lead the strategy, development, and application of quantitative modeling and simulation capabilities that inform early drug-development decisions through prediction of human pharmacokinetics and pharmacodynamics. This senior leader will build and scale a high-performing team that integrates quantitative data to reduce uncertainty and improve confidence in candidate selection and human-dose projections. 

The role combines deep scientific and technical expertise with strong organizational leadership. This role will be partnered closely with Precision Medicine, Toxicology, Operations, and the Clinical Pharmacology organizations to ensure a seamless transition from preclinical modeling to clinical development. 

Key Responsibilities 

  • Define and execute the strategy, roadmap, investment priorities, governance, and operating model for model-informed drug design  
  • Lead, develop, and retain a team with expertise in mechanistic and empirical modeling, PBPK, PK/PD, and quantitative systems of pharmacology to inform human-dose prediction. 
  • Establish a consistent modeling framework for investigational new drug–enabling activities 
  • Lead quantitative assessment of candidate differentiation, projected human exposure, dose and regimen feasibility, therapeutic index, and first-in-human starting-dose recommendations. 
  • Drive development and application of PBPK, allometric scaling, mechanistic PK/PD, QSP, and related approaches appropriate to the asset, therapeutic area, and available evidence. 
  • Collaborate across Research and Development to ensure models reflect high-quality, fit-for-purpose data and relevant product attributes. 
  • Establish model-development, qualification, validation, documentation, reproducibility, and lifecycle-management standards. 
  • Participate in integrated program teams as a subject matter of expertise to clearly communicating quantitative evidence, uncertainty, assumptions, tradeoffs, and recommended actions. 
  • Build external partnerships with academic institutions, technology providers, and scientific thought leaders to advance modeling capabilities. 
  • Manage the function’s budget, workforce plan, external vendors, and technology investments. 

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 in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Biomedical Engineering, Applied Mathematics, or a related quantitative discipline and 5 years of relevant pharmaceutical or biotechnology experience in translational modeling, DMPK modeling, PBPK, PK/PD, QSP, or related quantitative drug-development disciplines. 

OR

Master’s degree in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Biomedical Engineering, Applied Mathematics, or a related quantitative discipline and 9 years of relevant pharmaceutical or biotechnology experience in translational modeling, DMPK modeling, PBPK, PK/PD, QSP, or related quantitative drug-development disciplines.

OR

Bachelor’s degree in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Biomedical Engineering, Applied Mathematics, or a related quantitative discipline and 11 years of relevant pharmaceutical or biotechnology experience in translational modeling, DMPK modeling, PBPK, PK/PD, QSP, or related quantitative drug-development disciplines.

In addition to meeting at least one of the above requirements, you must have at least 5 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:

  • Advanced degree in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Biomedical Engineering, Applied Mathematics, or a related quantitative discipline; PhD required. 
  • 15+ years of relevant pharmaceutical or biotechnology experience in translational modeling, DMPK modeling, PBPK, PK/PD, QSP, or related quantitative drug-development disciplines. 
  • 5+ years of progressive leadership experience managing technical teams, functions, or major cross-functional programs. 
  • Demonstrated expertise applying quantitative models to preclinical-to-clinical translation, human PK prediction, and first-in-human dose selection. 
  • Proven ability to shape program strategy and influence senior scientific and business stakeholders. 
  • Excellent written and verbal communication skills, including the ability to make complex quantitative evidence actionable for executive and cross-functional audiences. 
  • Experience with PBPK platforms, QSP, physiologically based absorption modeling, allometric scaling, mechanistic PK/PD, or virtual-population approaches. 
  • Experience across multiple therapeutic areas and modalities. 
  • Experience establishing or scaling a translational modeling capability within a growing or complex organization. 
  • Strong record of scientific thought leadership through publications, patents, presentations, or industry participation. 
  • Experience working in a matrixed environment with clearly defined functional boundaries and shared program accountability. 
  • Brings clarity to scientific uncertainty and balances methodological rigor with timely program delivery. 
  • Develops technical leaders and fosters an inclusive, high-performance scientific culture. 
  • Establishes organizational influence through practical partnership, strong governance, and measurable business impact.

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

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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.

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.

 

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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.

Salary Range

USD - USD

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