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Your tasks and responsibilities
The primary responsibilities of this role, Director, Clinical Pharmacology Lead, are to:
Independently represent Clinical Pharmacology (CP) Oncology in global project teams (GPTs) and related clinical teams;
Take over leadership activities from the Head of CP Oncology for specific assigned tasks, as appropriate;
Ensure adequate consideration and implementation of all aspects of CP, Pharmacokinetics (PK) and Pharmacokinetics / Pharmacodynamics (PK/PD) 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 quantitative PK/PD activities to support clinical study design and dose/schedule selection for First in Human (FiH) first-in-human and other exploratory clinical studies in close alignment with other functions within Translational Medicine Oncology (TMO), Oncology Development as well as Pharmacology, Toxicology, DMPK and Pharmacometrics;
Provide in-depth CP, PK and PK/PD advise 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 in close collaboration with the respective clinical functions and study teams;
Closely interact with other functions within Translational Medicine Oncology (TMO) as well as within Oncology Development to define the best use of biomarker 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;
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;
Lead and manage the preparation of the CP sections of major clinical and regulatory documents (e.g. Common Technical Documents (CTDs), New Drug Applications (NDAs), Investigational New Drugs (INDs), Investigational Medicinal Product Dossiers (IMPDs) and provide global CP submission support for all countries / regions including the US, Europe, Japan, Asia Pacific, Canada and Latin America;
Represent CP Oncology externally, e.g. in meetings with authorities or key opinion leader (KOL) meetings and develop and manage KOL relationships to facilitate CP strategies as part of the overall development strategies;
Participate in critical in-licensing and out-licensing activities and independently provide CP, PK and PK/PD expertise in due diligences.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Leading Pharmaceutical Company seeks an incumbent who possesses the following:
Ph.D., M.D. or Pharm.D. with at least ten years extensive and profound expertise in the area of Clinical Pharmacology and Oncology Drug Development. Of this, at least six years of experience must be in Pharmaceutical industry or equivalent (e.g. Food & Drug Administration (FDA);
Strong background and demonstrated expertise in Clinical Pharmacology, PK and PK/PD including model-based drug development as evidenced by major Regulatory submission experience (e.g. NDAs, CTDs, INDs), scientific publications and presentations at major meetings;
Industry experience in applications of Basic Research and/or Clinical Research with the ability to translate preclinical projects to the clinic;
Proven ability to manage strategic, scientific and operational aspects of development projects from a Clinical Pharmacology perspective;
Evidence for leadership skills to direct and steer a team of experts, awareness of responsibility, efficient analytical thinking and working methods;
Capable of working self-dependently and on own initiative, excellent communication and organizational skills;
Ability to handle conflict and be highly resilient;
Very good knowledge of written and spoken English.
Command of a second major language
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