Director, Clinical Pharmacology and Pharmacokinetics

Disc Medicine•Massachusetts - Hybrid, MA

7d•$247,000 - $297,000•Hybrid

About The Position

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.

Requirements

PhD in clinical pharmacology, pharmaceutical sciences or related areas such as pharmacokinetics, pharmacology or drug metabolism
More than 10 years of industry experience working as a clinical pharmacologist.
Experience in conducting clinical pharmacology studies including study design, PKPD data analysis and/or population PK analysis, and result interpretation is required.
A working knowledge and previous experience in either (1) drug metabolism and drug-drug interactions or (2) biologics/large molecule development is required.
Familiarity with clinical pharmacology regulatory guidance and related areas is required.
Experience with regulatory agency interactions including written responses and IND packages is required.
Must excel at working in a highly collaborative matrix team environment.
Good organizational, communication [both oral and written], and interpersonal skills are required.

Nice To Haves

Experience with End of Phase 2 and NDA/MAA regulatory interactions is preferred.
Prior experience working with CROs is a plus.
Working experience with bioanalysis, data management, and statistical programming groups is preferred.
Advanced training in WinNonlin, R, NONMEM, and/or Monolix is preferred.
Hands-on experience performing population PK/PD analyses is preferred.
Broad familiarity with the drug development process is highly desired.

Responsibilities

Serve as a clinical pharmacology lead for multiple programs at Disc Medicine working directly with the multi-disciplinary teams.
Manage and execute clinical pharmacology deliverables in collaboration with internal and external partners in an efficient and scientifically rigorous manner and provide oversight for work conducted by contract research organizations (CROs).
Have scientific and budgetary responsibility for the design, execution, analysis, interpretation and reporting of clinical pharmacology related studies including first-in-human, drug-drug interaction, biopharmaceutics and ADME studies.
Establish and develop strong relationships with key cross functional partner functions such as clinical operations, clinical development, nonclinical toxicology, DMPK, biostatistics, medical writing, and regulatory.
Represent clinical pharmacology in program teams and in regulatory interactions including preparation of regulatory documentation and participation in meetings with regulatory agencies.