We are seeking an experienced and motivated Director to Senior Director of DMPK and Clinical Pharmacology to provide expert guidance on clinical pharmacology programs supporting drug discovery and clinical development. In this role, you will be responsible for authoring clinical protocols, study reports, and analyzing data (exposure/efficacy/safety) to support the development and registration of products. You will apply cutting-edge pharmacometrics methodologies to inform drug discovery, development, and regulatory decisions.
Key Responsibilities:
- Lead the design, execution, and interpretation of clinical pharmacology programs, including model-based analyses such as population pharmacokinetic (PK), pharmacokinetic-pharmacodynamic (PK/PD) modelling, exposure-response (ER) analyses, quantitative systems pharmacology (QSP), and physiologically-based pharmacokinetic (PBPK) modelling.
- Develop customized clinical pharmacology and DMPK (Drug Metabolism and Pharmacokinetics) plans to advance drug development.
- Write, review, and edit regulatory submissions (INDs, NDAs, IBs) and respond to regulatory inquiries related to clinical pharmacology.
- Ensure timely and accurate delivery of clinical pharmacology studies, maintaining adherence to budgets and timelines.
- Lead the preparation of scientific publications, including abstracts, posters, oral presentations, and manuscripts.
- Collaborate with and manage CROs (Contract Research Organizations) to ensure compliance with protocols, quality standards, and timelines for pharmacometrics analyses.
Qualifications:
- PhD or PharmD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutics, or related field.
- Extensive experience in clinical pharmacology with proficiency in model-based analyses (PK/PD, ER, QSP, PBPK).
- Knowledge of drug development processes and experience with regulatory submissions (IND, NDA).
- Strong scientific communication skills with a proven publication record.
- Experience in leading and managing cross-functional teams and external collaborations.
- Ability to manage multiple projects and adhere to strict timelines and budgets.
Benefits:
Full-time employees become eligible for benefits on the first of the month following 30 days of continuous service. These benefits include:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Employer-Paid Basic Life Insurance
- Supplemental Life Insurance
- Employer-Paid Short-Term Disability
- Long-Term Disability
- 401(k) Plan
- Paid Time Off
- Paid Holidays
