Director, Clinical Pharmacology

November 19

🗽 New York – Remote

Although this job is listed in New York, this company may be open to hiring remote in other states.

💵 $220k - $250k / year

⏰ Full Time

🔴 Lead

👔 Director

Apply Now

Receive Emails with Similar Jobs

Immunovant

WebsiteLinkedInAll Job Openings

Biotechnology • Pharmaceuticals • Healthcare Insurance

Immunovant is a company focused on advancing treatments for autoimmune diseases through a patient-focused approach. With a vision of enabling normal lives for people with autoimmune diseases, Immunovant applies its expertise in science to develop and test new therapies. The company emphasizes complex and variable needs across different stages and severities of diseases. Immunovant is committed to pushing forward its therapeutic areas and clinical trials, while also engaging with patients, caregivers, and investors about their ongoing studies and corporate initiatives.

51 - 200 employees

Founded 2018

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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.

🏖️ Benefits

• full range of medical, dental, vision • 401k • unlimited paid time off • parental leave