Director - Clinical Pharmacology
July 24
Description
• Develop and maintain comprehensive CP strategic development plans for assigned clinical development programs/studies • Provide CP subject matter expertise to the clinical study team/development team • Draft and finalize CP related report templates • Participate in the drafting, review, and finalization of clinical study protocols and study analysis plans (SAP) • Supervise and/or conduct pharmacokinetic/pharmacodynamic (PKPD) analyses • Draft, review, and finalize CP study reports and publications • Work closely with Regulatory to provide CP support of regulatory documents • Work closely with Quantitative Pharmacology (QP) colleagues to develop and deliver agreed quantitative strategies • Assist the Statistics, Data Management, Clinical, Preclinical/Nonclinical, Bioassay, as well as other functions, as needed
Requirements
• PhD, PharmD, or MD with training in CP, PKPD, 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 monoclonal antibodies programs • Strong experience with TMDD modeling • Expertise with PK, immunogenicity, drug-drug interactions (DDI), bioavailability (BA)/bioequivalence (BE), special populations, and dose selection • Hands on experience in using pharmacometrics (PMx) tools and software (e.g., WinNonlin, NONMEM, and R) for individual (e.g., noncompartmental analysis, NCA) and population PK (PopPK) analysis, modeling, and simulations (M&S) • 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 incredible attention to detail • Strong desire to work in a dynamic, interactive, fast-paced, innovative, and entrepreneurial environment • Natural collaborator who enjoys working on a cross-functional team
Benefits
• Equity, sign-on bonuses, and other forms of compensation • Full range of medical, dental, vision, 401k and other benefits • Unlimited paid time off • Parental leave
Apply NowSimilar Jobs
July 24
Lead digital transformation projects and develop data-driven strategies for client success.
July 24
Partner with private equity clients to enhance their finance functions.
🇺🇸 United States – Remote
💰 $1.5M Venture Round on 2021-02
⏰ Full Time
🔴 Lead
👔 Director
🦅 H1B Visa Sponsor
July 24
Lead communications efforts to enhance engagement and impact using AI for animal communication.
July 24
Create and implement strategies for government services business objectives related to defense.
July 24
Spearhead new business initiatives in the insurance sector using machine learning.