at Certara USA, LLC in Wilmington, Delaware, United States
Certara provides high-quality, regulatory-compliant pharmacokinetic and pharmacodynamic (PK/PD) analyses and modeling for regulatory submission packages. With the largest global team of PhD, PharmD and MD consultants, we leverage quantitative methods to build a comprehensive knowledge-base of drug discovery, pre-clinical, early-phase clinical, literature, and competitor data, which can be used to optimize decisions, including the "go/no go" that will lead to commercial activities.
Our Pharmacometric Team is 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.
Our pharmacometricians support:
Pre-clinical and clinical study analysis for new drug approvals
Product portfolio decisions
We are accepting applications for a Sr. Director of Pharmacometrics for our leadership team that want to develop their consulting career path by recognizing and seeking opportunities that match their ambition and personal interests. A career with our team will:
Deepen your strategic drug development expertise and your experience informing drug development decisions.
Hone your 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 your drug development expertise by working with a myriad of companies, molecular modalities, and therapeutic areas.
Accountable for oversight of a consultancy team to assure team members are sufficiently billable 80% of time in the office and profitable through maintenance of client relationships and writing of proposals.
Billable consultant 60-80%
Is part of the QSS-US Leadership team together with the regional Senior Vice President (SVP)
Accountable for organizational structure and operations of the consultancy team for which he or she is responsible
Accountable for recruitment and growth of their consultancy team in accordance with the IDD business strategy by defining and driving recruiting strategy, job analysis, interviewing, selection and on-boarding.
** This position can be remote **
Required Education, Experience, Training, and Knowledge:
PhD, MD, PharmD, or equivalent degree with formal training in business management, organizational design, and project management.
Minimum 15+ years related experience in consulting, strategy, planning and project management with a preferred minimum of 7 years industry experience.
In-depth knowledge of multiple M&S techniques and multiple TAs required.
Experienced in addressing comments/questions from regulatory agencies.
Demonstrates knowledge of, and a proven record of success, as an industry thought leader.
Strong experience managing team of professionals at various levels.
Demonstrated experience in the management and execution of complex projects.
Skills & Abilities:
Recognized expertise in modeling and simulation approaches (e.g., popPK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, data set creation, database augmentation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling).
In-depth modeling skills, ability to translate complex problems into incisive models to address them.
Deep knowledge of drug development, pharmacokinetics and pharmacology and basic science skills required.
Excellent verbal and written communications skills in English.
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.