Director, Infectious Diseases and Vaccines, Quantitative Pharmacology and Pharmacometrics

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 teams developing infectious disease or vaccine assets

• 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 and 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 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 diseases including respiratory viruses

• 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 and defending registration packages to support global filings

• A strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factor evaluation

• Experience in performing population PK PKPD or viral dynamic 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

Required Skills:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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