Director Clinical Pharmacology Modeling and Simulations

Job Description

General Summary:

The Director, Modeling & Simulations (M&S) Pharmacometrics will be responsible for independently determining, planning, and executing M&S analyses for an entire drug development program in close collaboration with cross-functional colleagues within the R&D organization. In this role, it is expected that the incumbent will represent M&S with cross-functional drug development teams, proactively advocate for model-based approaches, and clearly communicate M&S results. As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Key Duties and Responsibilities:

• Perform mechanism based PKPD and population PK and PK/PD analyses, clinical trial simulations, translational modeling (preclinical – clinical) and other model-based analyses independently on a regular basis for multiple products

• Present analysis results and strategic program planning to all levels of organization as needed for program team objectives with limited oversight in collaboration with related functions

• Represent M&S as the M&S lead on cross-functional drug development teams, proactively advocating model-based approaches to address development challenges

• Use of state-of-the-art M&S methodologies impacts decision making at program milestones based on quantitative principles. Execute in close collaboration with Biostats, Clin Pharm and other quantitative disciplines

• Represent M&S in preparation for regulatory responses and external regulatory interactions

• Supervise and mentor scientists at multiple levels

• Identify areas for, and contribute to the continuous improvement in efficiency and effectiveness of our M&S capability by supporting training activities, evaluating and incorporating new M&S tools as appropriate

• Design and lead departmental functions and represent the department in organizing company-wide, non-scientific initiatives.

• Demonstrate effective communication of M&S results written and verbal to a technical audience

• Integrate modeling into decision making by clearly communicating key results at team level and higher meetings

MINIMUM QUALIFICATIONS:

• PhD, in Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling preferred

• Typically requires a PhD and 10 years of experience or the equivalent combination of education and experience, in Pharmaceutical sciences, Pharmacometrics, Clinical pharmacology, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling preferred

• Management experience

• Possesses broad experience and leadership skills in clinical M&S with an excellent research record in the area of M&S, such as design and analysis of nonlinear mixed models, dynamic models, mechanistic models, adaptive designs with respect to model fitting, estimation, optimization, in particular differential equation dynamic modeling.

• Experience with regulatory interactions and responses to regulatory queries.

• Expertise with the use of NONMEM, PsN, R, and similar tools

• Excellent collaborative, leadership, verbal and written communication skills - experience managing direct reports is a plus.

Pay Range $184,000.00 – $276,000.00 USD annually

The range provided is based on what we believe is a reasonable estimate for the base salary   pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility   and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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Company Information