ED, Early Asset Lead - Antibody Drug Conjugates (Remote)

Description

The Translational Medicine and Clinical Pharmacology Lead (TMCP Lead)  1. Drives early clinical development of BI drug development projects, in particular rapid and informed decision-making, based on an integrated view of the respective translational expert functions. 2. Is responsible for the definition and implementation of Translational Medicine and Clinical Pharmacology aspects of a high quality early Clinical Development Plan (CDP) including path to Proof of Clinical Principle (PoCP). 3. Fulfills one of the following accountabilities and responsibilities: Director PCPK, Principal Pharmacometrician, Director - Biomarker Integrator (BMI), or similar cross-functional scientific & leadership experience in clinical and/or translational research and development. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

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. Full performance according to the respective "Director" job profile and/or cross functional leadership excellence in early clinical development is a pre-requisite and mandatory (but not sufficient) for an Translational Medicine and Clinical Pharmacology Lead.

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.
• Demonstr