Senior Director Clinical Pharmacology
The Senior Director of Clinical Pharmacology plays a vital role in guiding clinical trials for oncology
products, applying cutting-edge Clinical Pharmacology and Model-Based Drug Development (MBDD)
approaches. This position requires a collaborative, team-oriented mindset, thriving in a dynamic,
patient-centric research environment.
* Oversee and develop a Clinical Pharmacology organization for a growing clinical asset
* Lead expert data integration, analysis, and reporting of clinical pharmacology results for
internal and external interactions.
* Skillfully integrate pharmacokinetic, pharmacodynamic, and safety data for optimized dosing
across development phases.
* Demonstrate expert knowledge of PK/PD modeling and simulation for clinical dose decisions.
* Prepare comprehensive PK/PD reports and sections of Clinical Study Reports (CSR) and
* Contribute to clinical pharmacology sections in study protocols, analysis plans, study reports,
and development plans.
* Collaborate with various teams to ensure advanced modeling and simulation approaches
inform internal decisions and regulatory interactions.
* Work closely with clinical operations, Research bioanalytical scientists, Biometrics, and
Clinical Development for efficient Phase I-III study execution.
* D. degree or equivalent in Pharmaceutics, Pharmacology, Pharmacokinetics or PharmD with
12+ years of industry or equivalent experience in Clinical Pharmacology or similar
* Strong theoretical background and hands-on experience interpreting non-clinical and clinical
dose-response and PK/PD data.
* Neuroscience background strongly preferred.
* Proficiency with analysis software (e.g., WinNonlin, Phoenix NLME, NONMEM) strongly
* Prior experience in PK, PK/PD, and ADA of large molecules and/or vaccine therapeutics
* Knowledge of and experience with regulatory guidance related to clinical pharmacology.
* Medical, dental, and vision insurance with Prothena covering ~90% of plan premiums.
* Full premium for basic life and disability insurance for all employees.
* Eligibility for the Company's 401(k) plan with quarterly, non-discretionary contributions and
an annual discretionary Company match.
* 17 days of paid vacation accrued over the first year, paid sick time, and company-paid
TGI Life Sciences is acting as an Employment Agency in relation to this vacancy.