What are the responsibilities and job description for the Modeling & Simulations Director position at SpringWorks Therapeutics?
About the Role:
The Modeling & Simulation Director will combine strong pharmacometrics skills to independently determine, plan, and execute M&S analysis in close collaboration with cross-functional colleagues within the organization. In addition, this role will be responsible for developing quantitative dose- and exposure-response relationships in preclinical studies and for predicting efficacious human doses and evaluate a broad range of in vitro and in vivo data to develop integrated mathematical models characterizing the effects of drug candidates to support the advancement of the most promising molecules to investigational new drug (IND) filings and human studies. This role will also be responsible for conducted Population pharmacokinetic (PopPK) and/or exposure-response modeling for late-stage clinical assets to support regulatory filings (NDA, MAA, PMDA, etc). Additional responsibilities will include leading multiple cross-functional M&S projects to evaluate study design, dose selection, probability of success estimation, portfolio strategy, pediatric extrapolation, etc.
Responsibilities Include:
- Independently develops M&S analysis plans in alignment with an asset strategy, determines relevant outcomes, executes, and interprets multiple modeling analyses.
- Perform mechanism-based PKPD and population PK and PK/PD analyses, clinical trial simulations, translational modeling (preclinical – clinical) and other model-based analyses and in collaboration with other scientists on a regular basis.
- Perform dataset construction, evaluation and interpretation of results, and pre- and post-processing activities including informative graphics creation.
- Represents M&S on cross-functional drug development teams.
- Serves as the M&S lead on pharmacometric deliverables for a study, including population PK, PKPD, exposure-response, model-based meta-analysis, trial simulation, etc.
- Participates in preparation of regulatory responses and submissions.
- Participates in interactions with health authorities as MIDD SME, with some supervision
- Collaborates with internal and external SMEs to develop and enhance MIDD methodology and capability.
- Instruct and educate colleagues in the clinical pharmacology department.
- Perform other duties and responsibilities as assigned.
About You: Required Education, Skills, and Experience
- Education: Ph.D in a relevant scientific discipline
- 10 years of combined experience in scientific (preferably life science) research including the practical application of modeling and simulation.
- Direct experience in designing strategic integrated clinical pharmacology & modeling simulation plans in support of development of small molecule and/or protein therapeutics.
- Established track record of Model Based Drug Development. Hands-on experience in population PK/PD & PBPK modeling and simulation.
- Experience with PK and PK/PD strategies, data analysis, interpretation, and reporting of PK and PK/PD data from clinical studies.
- Established track record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance
- Experience with Pharmacology/drug/pharmaceutical modeling to characterize drugs using a software similar to Simcyp, GastroPlus, Pheonix, Monolix, NONMEM, Matlab, or Simbiology
- Expertise in clinical pharmacology and pharmacokinetics
- Knowledge of drug metabolism and disposition of small and large molecules.
- Ability to foster relationships within an organization and advance the concepts of MIDD
- A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP.
- Ability to ensure optimal relationships with key internal stakeholders, as well as CSPs, to enable the successful development and deployment of ECD and cross-functional development processes.
- Excellent verbal and written communication skills, as the position will interface with employees, vendors, and other external people.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to manage multiple responsibilities and shift priorities quickly while working under tight deadlines.
- This position must be able to work East Coast hours.
- Ability to travel occasionally (>15%).
