Scientist I, Clinical Pharmacology - United States
Want to know company name or location? Company managed [?]
- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
Job Description: Clinical Pharmacology Scientist I / II
- The Clinical Pharmacology Scientist I / Scientist II role will be responsible for the design, execution, interpretation and reporting of both nonclinical and clinical Pharmacokinetic/Pharmacodynamic (PK/PD) studies. With a growing portfolio, this individual will have the opportunity to work on small molecules, protein therapeutics and gene therapies across the development cycle (candidate selection to post marketing).
- This individual will work with Clinical Pharmacology leaders on projects and provide support in characterizing the Clinical Pharmacology profile with an emphasis on dose and regimen selection.
- Depending on experience, this individual could also serve as the Clinical Pharmacology representative on study and project teams and will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams and external collaborators.
- Design and interpret PK/PD studies in support of molecules in clinical and nonclinical development
- Analyze, Model, simulate and predict nonclinical and clinical data to drive decisions on dose and frequency of dosing
- Perform population PK and PK/PD analyses on drug candidates as they progress through clinical development
- Interact with pharmacologists, toxicologists, medical directors and regulatory affairs personnel within the company for the timely completion of clinical and nonclinical studies and regulatory filings
- Represent Clinical Pharmacology on multi-disciplinary study teams with a potential to represent the function on project teams
- Write protocol sections, analysis plans, reports, sections to INDs, NDAs, etc
- Ph.D. in a Pharmaceutical Science, Pharmacology or related field such as Bioengineering with an emphasis in PK/PD modeling.
- 0 to 2 years of industry experience (Scientist 1) with a strong background in Pharmacokinetics and Pharmacodynamics. Post-doctoral or some industry experience is preferred.
- Strong training in PK/PD analyses with a preference for population based modeling and simulation
- Extensive hands-on experience with non-compartmental and compartmental PK/PD analysis using WinNonlin and NONMEM software
- Excellent writing and verbal communication skills.
- Ability to work in a matrix environment and with different leadership styles.