Executive Director, Translational Medicine and Clinical Pharmacology Lead - Inflammation

Description

Duties & Responsibilities

• Demonstrates continuously strong strategic and operational leadership of matrix teams:
  • Serves as chairperson/Integrator of cross-functional team(s) leading Early Clinical Development
  • Represents Early Clinical Development activities up to the first clinical milestone, i.e. Proof of Clinical Principle (PoCP), and at the respective decision-making committees (HPSC, TALC, CEC, DC) and seeks approval for strategy for the development of a specific drug under his/her accountability.
  • Drives and is responsible for the definition and implementation of translational and clinical pharmacology aspects of a high quality early Clinical Development Plan (CDP) including path to PoCP.
  • In cooperation with the team members responsible for early clinical development, the Translational Medicine and Clinical Pharmacology Lead ensures the definition of reasonable PoCP criteria, state of the art clinical trial designs, feasibility of PoCP strategies as well as realistic timeline- and cost planning.
  • Regarding the functions involved in early clinical development, the Translational Medicine and Clinical Pharmacology Lead a) ensures timely alignment, b) coordinates work packages assigned to the respective team members and c) structures the information flow within and outside the team.
• Drives rapid decision-making for the translational medicine and clinical pharmacology aspects during early clinical development based on an integrated view of the respective expert functions
  • Is a recognized leader for translational medicine and clinical pharmacology aspects of clinical development
  • Acts as key contributor in a complex, critical and strongly regulated environment
  • Continuously evaluates new preclinical and clinical data/information from internal and external sources and their relevance for further clinical development and act appropriately on it
  • Identifies new opportunities for lean, flexible and innovative approaches customized to the project needs
• In addition to the described strong strategic and operational leadership skills, the Translational Medicine and Clinical Pharmacology Lead also provides expert knowledge regarding the integration of Translational Medicine, Biomarker, Clinical PK/PD or Pharmacometrics into BI projects.

Requirements

• MD or PhD from an accredited institution with profound experience in the field of Clinical Development, TMCP and specialist in the respective Therapeutic Area.
• Expert knowledge in preclinical and clinical drug development (Phase I/II/III) with at least ten (10) years of experience in clinical development, exploratory clinical, and clinical pharmacology in the pharmaceutical industry.
• Senior professional with several years of integrative leading experience in a matrix environment and with multi-year year experience in early / translational clinical development including e.g. translational / biomarker / early clinical research / development / clinical pharmacology or pharmacometrics.
• Familiar with regulatory guidelines and requirements, GCP and ICH guidelines.
• Demonstrated managerial skills in a global and complex setting and evidence of inspirational and integrative leadership of individuals and teams as well as team work in a multidisciplinary environment.
• Excellent written and verbal communication skills, with successful presentation capabilities.
• Track record of successfully leading and implementing innovative projects.

Compensation Data

This position offers a base salary typically between $200,000 and $347,000.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here.