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Immunovant · 20 hours ago

Director, Clinical Pharmacology

United States

Full-time

Remote

Lead/Staff, Director/Executive

$220K/yr - $250K/yr

5+ years exp

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. The Director of Clinical Pharmacology is responsible for providing strategic and scientific expertise, collaborating with cross-functional teams, and delivering the tactical execution of the Clinical Pharmacology strategy for clinical development programs.

BiopharmaBiotechnologyPharmaceutical

Hiring Manager

Mohammad Ouranus

Responsibilities

Develop and maintain comprehensive CP strategic development plans for all clinical development programs/studies

Provide expert-level CP and expert to the clinical study team/development team

Collaborate with Quantitative Pharmacology (QP) vendors or colleagues to develop and deliver quantitative strategies to support assigned development plans

Formulate and finalize CP related report templates, as well as data handling and analysis standard operating procedures (SOP)

Contribute to the drafting, review, and finalization of clinical study protocols and study analysis plans (SAP)

Supervise and/or conduct pharmacokinetic/pharmacodynamic (PKPD) and biomarker analyses, ensuring high-quality and accurate results

Lead the drafting, reviewing, and finalizing CP study reports and publications, collaborating with the Medical Writers to incorporate CP-related sections into clinical study reports (CSR)

Collaborate closely with Regulatory to provide CP support of regulatory documents, communications, and presentations as needed (IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of relevant BLA sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings)

Support cross-functional teams, including Statistics, Data Management, Clinical, Preclinical/Nonclinical, Translational Science, as needed

Qualification

PhDPharmDMDClinical PharmacologyPharmacokinetics/PharmacodynamicsPharmacometrics toolsMonoclonal antibody experienceRegulatory knowledgeCommunication skillsCollaboration skills

Required

PhD, PharmD, or MD with training in CP, PK/PD, Pharmacology, and Pharmaceutical Sciences

5+ years of experience in the application of CP within the context of drug development in the healthcare industry

Expertise with PK, PD, immunogenicity, drug-drug interactions (DDI), bioavailability (BA)/bioequivalence (BE), special populations, and dose selection

Hands-on experience in pharmacometrics (PMx) tools and software (e.g., WinNonlin, NONMEM or Monolix, and R) for individual (e.g., noncompartmental analysis, NCA) and population PK/PD (PopPK/PD) analysis, modeling and simulations (M&S), and exposure-response (E-R)

Knowledge of current practices, regulatory requirements in clinical development, bioanalysis, biopharmaceutics, pharmacology, toxicology, and formulation development

Excellent written and oral communication skills with meticulous attention to detail

Thrives in a dynamic, interactive, fast-paced, innovative, and entrepreneurial environment

Natural collaborator who enjoys working on a cross-functional team