Modeling & Simulations Associate Director

Vertex Pharmaceuticals Inc (US); Boston (MA); Hybrid; USD 168,000 - 252,000; Full time

Benefits offered by this job

Annual bonus

Annual equity awards

Medical benefits

Paid time off

Educational assistance

Commuting subsidy

401(k)

Job summary

Vertex Pharmaceuticals Inc is seeking a Modeling & Simulations Associate Director to lead M&S activities across cross-functional drug development teams in close collaboration with Clinical Pharmacology, Biostatistics, Research and other R&D colleagues.

You will plan and execute advanced analyses using PK/PD, population PK/PD and trial simulations to inform dose selection, study design and probability of success, while mentoring teams and expanding M&S capabilities.

Qualifications

• Advanced degree with strong pharmacometrics focus and PK/PD modeling expertise.
• Proven ability to lead cross-functional drug development analyses.
• Experience with population PK/PD modeling and trial simulations.

Responsibilities

• Lead M&S plans and analyses in cross-functional teams integrated with development plans.
• Contribute to decision making on study design, dose selection and success probability.
• Perform mechanism-based PK/PD analyses and trial simulations regularly.

Skills

PK/PD modeling

Population PK/PD

Clinical trial simulations

NonMem

PsN

R

Phoenix

leadership

collaboration

communication

Education

PhD in Pharm/Pharmacometrics or quantitative discipline

6+ years in pharmacometric modeling

Master's + 10 years experience in pharmacometrics

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

$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. 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.

Benefits

• annual bonus
• annual equity awards
• overtime pay
• medical, dental and vision benefits
• 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.

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.