Director, Clinical Pharmacology and Pharmacokinetics

The role

The Clinical Pharmacology Lead provides strategic and scientific leadership across multiple programs. This person leads the design, execution, analysis, and interpretation of clinical pharmacology studies and represents the function in regulatory interactions.

What you will do

• Serve as a clinical pharmacology lead for multiple programs working with multi-disciplinary teams.
• Manage and execute clinical pharmacology deliverables with internal and external partners.
• 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.
• Establish and develop strong relationships with cross functional partner functions.
• Represent clinical pharmacology in program teams and in regulatory interactions.
• Prepare regulatory documentation and participate in meetings with regulatory agencies.

Required qualifications

• 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
• A working knowledge and previous experience in either (1) drug metabolism and drug-drug interactions or (2) biologics/large molecule development
• Familiarity with clinical pharmacology regulatory guidance and related areas
• Experience with regulatory agency interactions including written responses and IND packages
• Must excel at working in a highly collaborative matrix team environment
• Good organizational, communication [both oral and written], and interpersonal skills

Nice to have

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

Benefits

• comprehensive benefits
• competitive compensation packages

About the company

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. The company aims to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology.