Director Clinical Pharmacology Modeling and Simulations
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: April 18, 2024
Job Description:
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 DescriptionGeneral
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 meetingsMINIMUM
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. #LI-AR1 #LI-Remote 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 ApplicationAssistance@vrtx.com. Similar Jobs (3) Vertex Summer
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Keywords: Vertex Pharmaceuticals, Revere , Director Clinical Pharmacology Modeling and Simulations, Executive , Boston, Massachusetts
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