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
- Line extensions
- In-licensing options
- Product portfolio decisions
We accepting applications a Sr. Director/VP 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.
Percentage of Travel Required: 10-20%
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,