Executive Director, Modeling & Simulations

Vertex Inc.•Boston, MA

1d•Hybrid

About The Position

The Executive Director, Modeling & Simulations (M&S) manages strategic, scientific and operational aspects of M&S within the Early Clinical Development Department at Vertex. The incumbent is responsible for the implementation of modeling and simulation strategy at Vertex; including but not limited to traditional PK/PD, population PK, exposure-response, model-based meta-analysis, clinical trial design and simulation, mathematical disease models, mechanistic modeling and analyses of multidimensional data. This role will have final approval on providing direction and guidance for M&S plans across programs. 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. 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.

Requirements

Demonstrated ability to lead teams and manage people
Experience designing clinical pharmacology and pharmacometrics components of filing packages and associated clinical studies
Regulatory agency interactions including written responses and IND packages
End of Phase 2 and NDA/MAA regulatory experience
Support of drug development programs in all Phases including life-cycle management
Strong experience leading cross-functional teams
Academic or clinical post doctoral training with significant publication history
Superior communication skills
Proactive problem solver and demonstrated ability to work in a matrix environment
Master's or PhD in Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling
PhD with 20 years or Master's Degree with 25 years’ experience in the application of pharmacometric and other modeling methodologies in the context of drug research & development in industry, academia or regulatory agencies
Strong management experience

Responsibilities

Leading and developing the Modeling & Simulation team
Champion the use of modeling and simulation to impact decision making in clinical and exploratory development
Manage a group of senior leaders comprised of Senior Directors and Director level employees
Provide expert input for internal review of all documents internal and external related to modeling and simulation or M&S derived outputs
Represent programs in external partnerships and advisory boards
Oversee and contribute to regulatory and safety documents
Represent modeling and simulation during face-to-face regulatory interactions
Provide management and career development to associate program leads
Assist in recruitment and hiring for the M&S group

Benefits

annual bonus
annual equity awards
overtime pay
inclusive market-leading benefits
medical benefits
dental benefits
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
generous commuting subsidy
matching charitable donations
401(k)