Director Clinical Pharmacology Modeling and Simulations

Boston, MA, United States

Director Clinical Pharmacology Modeling and Simulations page is loaded Director Clinical Pharmacology Modeling and Simulations Apply locations Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id REQ-20569 Job Description

General Summary:

The Director, Modeling & Simulations (M&S) Pharmacometrics will be responsible forindependently 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

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected].

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