General Scope and Summary
Sage Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for delivering best practice within the analyses of Phase I studies, driving the simulation of phase II & III studies, and characterizing the disease progression within various disease models. The Modelling and Simulation Director will act as an expert within the Phase I through III studies, conducting population PK/PD analysis and writing the M&S reports. They will work independently to handle complex models within these various studies, while interacting and collaborating with internal project teams and external agencies.
Roles and Responsibilities
- Conduct population PK/PD analysis for pooled Phase 1 studies, perform trial simulation for Phase 2/3 studies, and write M&S reports.
- Conduct trial simulations for Phase 2/3 studies; characterize the time course of disease progression for complex disease modalities.
- Write M&S documents (e.g. M&S report, analysis plan, dataset specification)
- Work independently on complex studies/models while interacting effectively with internal colleagues, external CROs, as well as regulatory agencies.
- Planning, Execution and Delivery of Modeling and Simulation at the global level within clinical development.
- Pharmacometrics methodology implementation and design for R&D objectives.
- Submission and drug development support for regulatory decisions.
- Identify modeling plans and results for development teams.
- Collaborate with other quant
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- PhD in Statistics, Mathematics, Pharmacology or related field with a minimum of 6 years of industry experience.
- Demonstrates significant knowledge of pooled Phase 1 studies, PK/PD and biomarker data, PK/PD analysis-ready data file derivation, complex disease modalities, regulatory guidelines pertaining to M&S, and programming and analytical software.
- Proficiency in quantitative analyses (including population PK, PK/PD, exposure-response, and drug-disease modeling) and clinical trial simulations.
- Prior experience in applying modeling and simulation to clinical drug development.
- Familiarity with following systems: SPLUS, Matlab, Monolix NONMEM, R, PsN, Xpose, WinNONLIN.
- Therapeutic knowledge in CNS diseases or PPD a plus.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong written and verbal communication skills.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage.