Director, Pharmacometrics (Modeling and simulation) - US
At Certara, we accelerate medicines to patients by partnering with life science innovators.
In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:
informed decision-making & reduced clinical trial burden
higher R&D productivity
improved patient outcomes& increased patient access to medicines
accelerated regulatory approval
Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.
Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.
Our Pharmacometricians are responsible for supporting quantitative decision-making in drug development through the development and application of population PK, PK/PD, exposure-response and other models. Qualified candidates will have the ability to work on a variety of therapeutic indications and data types and must be experts in applied Population PK, PK/PD, and/or exposure-response modelling and simulation to support drug development.
We are looking for Pharmacometricians that want to:
Develop their consulting career path by recognizing and seeking opportunities that match their ambition and personal interests.
Deepen their strategic drug development expertise and their experience informing drug development decisions.
Hone their pharmacometric techniques with fit-for-purpose modelling approaches leveraging e.g. model-based meta-analysis, target-mediated drug disposition models, and E-R trial-simulations.
Broaden their drug development expertise by working with a myriad of companies, molecular modalities, and therapeutic areas.
** This position can be remote **
Act as the primary point of contact for clients and collaborate with junior consultants to deliver on project objectives.
Support projects for Certara's clients by working in teams with junior consultants, other senior expert modelers, and drug development consultants.
Hands on pharmacometric modeling on client projects as a billable consultant.
May lead/coordinate company initiatives (e.g. IT, methodology, efficiency, automation, quality).
Grow the business by writing project proposals and winning business from new and existing clients.
Skills & Abilities
PhD, MD, PharmD in Bioengineering, Pharmaceutical Sciences, Pharmacology, Statistics, Applied Mathematics, Engineering, Medicine, or related field.
6 to 10 years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments.
Solid experience in pharmacometrics, clinical pharmacology, pharmacokinetics, or a related discipline in a project team setting is preferred, whether in academia or industry.
Expertise in PK/PD modelling with strong quantitative skills applied to develop models with nonlinear behavior, mechanistic or semi-mechanistic components relating to mechanism of action and tailored to meet specific drug-development questions.
High proficiency in PK/PD and statistical software (e.g., NONMEM, R).
Expert in modeling (e.g., popPK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, dataset creation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling).
Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management and filings preferred.
Independent performance of analysis and modeling and development of reports with limited supervision.
Comfortable in a client environment able to communicate with and collaborate with peer scientists.
Developing ability to identify new business development opportunities through client interactions.
Proficient in spoken and written English. Certara is a global company, and additional languages are of benefit.
Certara is a growing company that provides a novel and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.
The well-being of our employees is a priority at Certara, and that is why we support the most important aspects of their lives:
Financial - competitive pay, incentives, retirement plans, income security programs
Health and Wellness - comprehensive benefit package, wellness programs, healthy lifestyle office environments
Work/Life -unlimited paid time off and an employee assistance program
Growth & Development - performance driven environment
Community Impact - volunteering opportunities, matching gifts, charitable contributions
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.