Modeling & Simulations Associate Director

Vertex Pharmaceuticals LLC; Boston, Northern (MA, KY); Hybrid; USD 168,000 - 252,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a Modeling & Simulations Associate Director in Boston, MA to lead cross-functional drug development teams with state-of-the-art M&S methodologies. You will design and execute PK/PD analyses, clinical trial simulations and mechanism-based modeling to support critical development decisions.

The ideal candidate holds a Pharmacometrics-focused advanced degree with 6+ years (PhD) or 10+ years (Master's) in pharmacometrics applied to drug R&D, and has strong

Qualifications

• Master's or PhD in pharmaceutical sciences or related quantitative discipline with PKPD focus.
• PhD with 6 years or Master's with 10 years experience in pharmacometric applications in drug R&D.
• Experience in industry, academia or regulatory settings.

Responsibilities

• Lead cross-functional drug development teams on Modeling & Simulation plans and analyses.
• Develop and execute mechanism-based PK/PD analyses and population PK/PD analyses.
• Contribute to efficiency by evaluating new Modeling & Simulation tools and supporting training.

Skills

Population PK

PKPD modeling

Clinical trial simulations

Leadership

Collaborative skills

Communication

Drug development

Education

Pharmacometrics-focused advanced degree

Quantitative discipline

Tools

NonMem

PsN

R

Phoenix

Job description

Job Description General Summary: The Modeling & Simulations Associate Director will be responsible for developing and executing M&S strategies and activities in cross functional drug development project teams in close collaboration with colleagues in Clinical Pharmacology, Biostatistics, Research and other colleagues within the R&D organization. This role determines, plans, and executes technically challenging analyses by using state of the art Modeling & Simulation methodologies to strongly contribute to critical decision making.

Key Duties and Responsibilities

As Modeling & Simulations (M&S) lead in one or more cross functional drug development teams, responsibilities include the development and execution of Modeling & Simulation plans and analyses fully integrated with the overall development plans By using state of the art Modeling & Simulation methodologies strongly contribute to critical decision making like study design, dose selection, probability of success estimation etc. Independently perform mechanism based PKPD and population PK and PKPD-analyses, Clinical trial simulations and other model based analyses on a regular basis 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.

Knowledge and Skills

A specialized understanding of biology, pharmacokinetic and quantitative pharmacology (PKPD) principles. Excellent hands-on skills in population PK and PKPD modeling, mechanistic PKPD modeling, Clinical trial simulations, Disease progression modeling, etc. Excellent skills in the use of NonMem, PsN, R, Phoenix, and similar tools Demonstrated strong leadership-, collaborative and influencing skills Excellent, verbal and written communication skills In-depth experience working in clinical development teams and integrating the use of PK/PD modeling and/or modeling of complex biological system.

Education and Experience

Master's or PhD in Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling . Typically requires the following: PhD and 6 years experience or Master's Degree and 10 years of experience in the application of Pharmacometric and other Modeling methodologies in the context of drug research & development in industry, academia or regulatory agencies.

Pay Range

Pay Range: $168,000 - $252,000 Disclosure Statement: 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.

Flex Designation

Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid

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 [e-mail].

Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex’s global headquarters is now located in Boston’s Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.