Vacancy Details

Senior Director Clinical Pharmacology

Position Overview:

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.

Key Responsibilities:

* 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

regulatory submissions.

* 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.

Benefits Overview:

* 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.

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