Job Abstract

Job Description

Directors in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications. Directors perform job duties independently with minimal supervision, lead QP2 efforts on drug development programs, and author strategic documents.

Directors are expected to have or be developing expertise in several areas, including:

• Serving as an expert representative for QP2 on Infectious Disease/Vaccine development teams

• Framing critical drug development questions for optimizing model-based development

• Developing and executing translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and other model-based analyses

• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings

• In partnership with key cross-functional area experts, strategically frame and progress issues related to clinical pharmacology and biopharmaceutics

• Mentoring and/or supervising junior colleagues to perform the above duties and to develop the above capabilities

The Director is a skilled quantitative drug/vaccine developer, with a strong, integrated understanding of the strategic elements of drug discovery and development.  They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions.  In addition to the responsibilities described above, Directors demonstrate outstanding leadership and communication skills. They collaborate with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug development teams.

This role will be focused on efforts in the infectious disease and vaccines therapeutic area.

Required:

• a Ph.D. or equivalent degree with at least seven years of experience OR (a PharmD or equivalent degree with at least nine years of experience where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.

• Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

• Experience with modeling programing language(s) (e.g. R, NONMEM, Matlab, SAS, or other similar )

• Direct experience in regulatory interactions and filings for small molecule and/or biologic drug development

Preferred:

• Prior experience working in Infectious Disease and/or Vaccines

• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry.

• Ability to influence regulatory strategies including independently formulating registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author, defend regulatory filings.

• Experience in performing population PK/PKPD analyses using standard pharmacometric software (e.g. NONMEM, Monolix, Phoenix, etc.)

• Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.

• Scientific understanding of biopharmaceutical and ADME properties of small molecules and/or biologics

• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.

• Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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