Senior Director, Pharmacometrics, IDD (USA)

Job 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.

Responsibilities:

• 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.

Qualifications:

• 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.