Medical Sciences Director - Modeling and Simulation Job at Amgen
Career Category
Scientific
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Medical Sciences Director - Modeling and Simulation
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will be responsible for the development and implementation of the modeling and simulation strategies and execution of tasks for clinical development candidates across multiple novel modalities including T-cell engagers, cellular and nucleic acid based therapies in addition to monoclonal antibodies and small molecules. Key responsibilities include leading a team of modelers responsible across multiple therapeutic areas for:
- Conducting PK/PD and exposure-response analyses of data from early to late phase clinical studies using pharmacostatistical and relevant innovative modeling and simulation techniques
- Performing meta-analysis using proprietary and/or literature data
- Participating in cross-functional project teams and providing scientific input for dose selection for early and late stage clinical study designs using quantitative methods
- Contributing to clinical pharmacology plans by establishing and implementing high impact modeling and simulation strategy for clinical development candidates
- Authoring PK/PD reports and contributing to summary documents for regulatory submissions.
Win
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 and 4 years of Modeling & Simulation experience in the Biotechnology/ Pharmaceutical Industry
Or
Master’s degree and 8 years of Modeling & Simulation experience in the Biotechnology/ Pharmaceutical Industry
Or
Bachelor’s degree and 10 years of Modeling & Simulation experience in the Biotechnology/ Pharmaceutical Industry
And
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
- PhD in applied (bio)statistics, (bio)engineering, applied biomathematics/biophysics or related fields with equivalent professional degrees
- 10+ years of experience as Modeling & Simulation scientist in the Biotechnology/ Pharmaceutical Industry.
- 3+ years of experience mentoring and supervising junior modelers
- Deep understanding of application of pharmacometrics in early and late phase clinical development
- Expertise and past hands-on experience analyzing pharmacokinetic, efficacy and safety data from clinical trials using advanced pharmacometric or statistical modeling methodologies and conducting clinical trial simulations to assist study design
- Expertise in standard pharmacometric software (e.g. NONMEM, R, SAS, MATLAB) and programming languages
- Expertise in binary and categorical data analyses, time-to-event (hazard) models, Poisson models, logistic regression, MCMC and Bayesian methods as applied to exposure-response analyses, meta-analyses and Population PK and PKPD analysis
- Hands-on experience and expertise in applications of AI/ML in pharmacometrics
- Expert knowledge in developing modeling analysis plans, population PKPD and translational modeling strategies, developing clinical study designs and dose optimization
- Track record of regulatory filings (NDA/BLA) and responding to regulatory agency questions and knowledge of global regulatory requirements and guidances on quantitative analyses
- Experience guiding the development/maintenance pharmacometric infrastructure, justifying and implementing innovative pharmacometric software/tools, leading innovative methodology/algorithm development for modeling and simulations, and coordinating trainings and educations to adopt groundbreaking technologies in pharmacometrics
- Experience recognizing and anticipating discovery/translation/development problems that can be addressed by applying quantitative methods and finding effective solutions in partnership and collaboration with cross-functional teams to enable decision-making. Track record of influencing a broad spectrum of collaborators toward achieving business goals
- Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment are essential.
- Previous record of scientific contributions through peer-reviewed articles and external presentations
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $212,777 - $234,792.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
.
Salary Range
203,526.00 USD - 224,584.00 USD
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