Careers

Associate Director/Director, Pharmacometrics/Clinical Pharmacology

Disc Medicine is searching for an Associate Director/Director in Pharmacometrics/Clinical Pharmacology. The successful candidate will provide modeling and simulation strategy and execution for key decisions to support drug development. This includes quantitative rationale for dose and schedule selection, safety margin estimation, and pediatric investigation plans. This person is expected to interact with cross-functional teams providing Pharmacometric and other scientific inputs. The successful candidate will work with development teams to achieve program goals, work with minimum oversight to provide strategy for modeling and simulation support of regulatory filings and is responsible for developing regulatory documents to support this strategy. The candidate should have expertise in pharmacometrics with strong knowledge of best regulatory practices, compliant PK/PD and pharmacometric data structures, and analysis methodology. The candidate is also expected to be an active scientific contributor through publications in the areas of Clinical Pharmacology and Pharmacometric Science.

Key Responsibilities

• Represent pharmacometric at cross-functional teams to provide modeling and simulation support to enable internal decisions and regulatory filings.
• Represent Disc Medicine at regulatory meetings and respond to regulatory inquires related to pharmacometrics.
• Manage outsourced pharmacometric work to ensure high quality deliverables of PK/PD analyses including population PK, PK/PD modeling and simulation, mechanistic modelling, PBPK, exposure-response and conc-QT analyses.
• Develop novel modeling and simulation methodology and establish new platforms to improve development timeline and efficiency.

Minimum Requirements

• Ph.D.  with > 6 yrs experience in pharmacometrics in pharmaceutical industry.
• Strong understanding of model based data analysis, simulation methodologies, pharmacokinetics/pharmacology principles, statistics and pathophysiology with extensive hands-on experience in population pharmacokinetics, exposure-response, concentration-QT, PBPK, and mechanistic PK/PD model analyses.
• Has excellent interpersonal, organizational and communication skills. Experience in cross-functional interactions in matrix teams.
• Knowledgeable of regulatory and ICH guidelines in clinical pharmacology and pharmacometrics.
• Experience in writing and presenting pharmacometrics data to regulatory authorities in supporting IND to NDA/MAA applications.
• Track record of scientific excellence in pharmcometrics, evidenced by publication in scientific journals and/or presentation at scientific conferences.
• Broad experience in small molecule and biologics drug development supporting early and late-stage drug development.
• Experience in hematology and Rare disease drug development.
• Software experience in WINNONLIN, NONMEM, Monolix, SAS, and/or R.

About Disc Medicine:

Disc Medicine is a biopharmaceutical company committed to applying our scientific leadership in hematologic diseases to transform the lives of patients. We are committed to bringing hope to patients who suffer from hematologic diseases through innovation. Our team has built a pipeline of first-in-class therapies that each have the potential to address a wide array of hematologic diseases, ranging from rare genetic disorders to widely prevalent anemias associated with chronic disease.

Interested in joining our team? Please contact us at careers@discmedicine.com