Senior Director Clinical Pharmacology Lead

 

Senior Director Clinical Pharmacology Lead 

         

The Clinical Pharmacology Lead (CPL) Oncology will bring an extensive experience and knowledge of the Clinical Pharmacology (CP) field for all phases of Oncology drug development projects. This position will play a key role in management of interactions with KOLs as well as with regulatory authorities will work closely with Pharmacokinetics specialists, Translational Sciences, Pharmacometrics, Research, Clinical Development, Regulatory, Medical Affairs and Commercial/Marketing functions. Ultimately, the position aims to optimize decisions on drug development projects (particularly the dosing strategy) and advance products to regulatory approval with a competitive and state-of-the-art product label.

 

The Clinical Pharmacology Lead builds an end-to-end clinical pharmacology strategy and is responsible for its successful execution for all development programs.

 

Together with cross-functional Program Team (PT) and Translational Science Team (TST) members, the Clinical Pharmacology Lead will complete all globally relevant Clinical Pharmacology activities from early research up to Life Cycle Management (LCM) in a time- and resource efficient manner, significantly shaping the value of the product. This individual will ultimately drive quantitative decision making, in so doing aiding objective assessment of the clinical assets and creating highly competitive drug labels.

 

  

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities for this role Senior Director Clinical Pharmacology Lead are to:

 

• Independently represent Clinical Pharmacology (CP) Oncology in Product Teams (PTs) and related clinical teams;
• Anticipate and ensure adequate consideration and implementation of all aspects of CP, and Pharmacokinetics/Pharmacodynamics including model-based development approaches for all phases of Oncology drug development projects;
• Set-up, execute and coordinate the CP strategy including related core CP studies in line with the overall development and submission strategy for assigned projects;
• Drive PK/PD activities to support study design and dose / schedule selection for first-in-human and other exploratory clinical studies in close alignment with other functions within Red Onc as well as Toxicology, DMPK and Pharmacometrics;
• Provide in-depth subject matter advice and expertise to independently design, plan, execute and evaluate core CP studies as well as to adequately support relevant Oncology Development and Global Medical Affairs (GMA) studies with CP components such as dosing strategies, drug-interaction potential and exposure-response/safety analysis. To be achieved in close collaboration with the respective Oncology Development / GMA functions and study teams;
• Closely interact with other functions within Research and Early Development Oncology (RED ONC) as well as within Oncology Development to define the best use pharmacology concepts in conjunction with modelling and simulation approaches for development projects;
• Independently evaluate and report CP related results, draw consequences from critical outcomes, adapt the project plan by implementing appropriate measures to avert risks in the context of the drug development project. Communicate clearly with internal and external parties to elicit these measures;
• Constantly look for innovative approaches in the field of CP and ensure optimal utilization of resources and appropriate strategies to make go/no go decisions on programs in a timely and cost effective way;