Director - Clinical Pharmacology and Pharmacokinetics

POSITION OVERVIEW:

Reporting to the Vice President of Clinical Pharmacology the Clinical Pharmacology Lead will provide strategic and scientific leadership across multiple programs at Disc Medicine, serving as the clinical pharmacology representative on cross-functional development teams. This role will lead the design, execution, analysis, and interpretation of clinical pharmacology studies and deliverables, including first-in-human, drug-drug interaction, biopharmaceutics, and ADME studies. The successful candidate will partner closely with internal teams, external vendors, and CROs while providing scientific and budgetary oversight of clinical pharmacology activities. The role will also represent Clinical Pharmacology in regulatory interactions and contribute to regulatory strategy and submissions.

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.

 REQUIREMENTS:

• Education: 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. The exact level and responsibilities will depend on the individual’s experience and interpersonal skills.
• 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. 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.
• Must excel at working in a highly collaborative matrix team environment.
• Good organizational, communication [both oral and written], and interpersonal skills are required.