Director, Clinical Pharmacology

The Role:

Reporting to Vice President, Translational Science, this position is responsible for providing strategic and scientific expertise, representing Clinical Pharmacology (CP) in the highly dynamic cross-functional clinical development team, as well as collaborating with both internal and external stakeholders to deliver the tactical execution of our CP strategy. This role will work as an independent contributor to provide CP subject matter support to new and on-going clinical programs. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.

Key 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.

Requirements:

• 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).
• Previous experience with monoclonal antibody (mAb) therapeutics in autoimmune diseases is preferred.
• 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.

Work Environment:

• Immunovant’s headquarters is located in New York City.  The position is flexible for remote work.
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel may be required (<10%).