Senior Director, Pharmacometrics, IDD

Reference #: 1985

OverviewJob Summary:

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.

Pharmacometricians 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.

ResponsibilitiesResponsibilities:

Is a billable consultant (80% of "time in the office"). Consulting typically via hands-on modeling. May provide project leadership.

Has in-depth knowledge of multiple M&S techniques (e.g. PopPK, PKPD, MBMA, statistical modeling) and multiple TAs.

May act as and/or support account leader.

May lead projects of multiple consultants.

May support manager in Business Development through maintenance of client relationships and writing of proposals (with support from managers).

May supervise project contributions of Associates and Modelers.

May lead company initiatives (e.g. IT, methodology, efficiency, automation, quality).

Supports managers in recruitment.

Conducts quality control and quality assurance activities on model codes and reports.

QualificationsQualifications:

PhD, MD, PharmD in Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields.

7 to 10 years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments.

Experience in moving compounds through the clinical trials process and experience with various elements of clinical development and trial design and management and filings.

Demonstrated skills and experience in pharmacometrics, clinical pharmacology, pharmacokinetics and pharmacodynamics in a project team setting (including leadership roles), with clients as well as internal staff.

Know-how and experience in a specific therapeutic area, such as oncology, cardiovascular, immunotherapy or pediatric products is of interest.

Experience in addressing comments/questions from with regulatory agencies is desired.Skills & Abilities:

Recognized expertise in modeling (e.g., popPK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, dataset creation, database augmentation, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling).

Expert in PK/PD and statistical software (e.g., Phoenix WinNonlin, Phoenix NLME, Trial Simulator, NONMEM, Monolix and WinBugs) and programming language(s) (e.g., R, SAS, S-Plus).

General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology is preferred.

Drug development experience in complex biologics including cell and gene therapy from Phase 1 to post marketing is preferred.

In-depth modeling skills, ability to translates complex problems into incisive models to address them.

Independent performance of analysis and modeling and development of reports with minimal supervision.

Well-developed project planning and management skills work plan writing, budgeting, delivery.

Ability to independently lead project teams and actively mentor others.

Strong understanding of business strategy and offerings with ability to contribute to the RFP process and business development efforts.

Comfortable in a client environment able to communicate with and collaborate with scientists and key decision makers.

Ability to identify new business development opportunities through client interactions.

Proven ability to lead company initiatives.

Excellent writing, editing, verbal communication in English.

Excellent interpersonal skills.Other Information:

Number of Employees Supervised: could range from 0 to 5Percentage of Travel Required: As required to support corporate and business activities, typically less than 10%Spec al Requirements: None

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.