Sr AD​/Director, Clinical Pharmacology Lead; Remote

Overview

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 several 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.

The Director, Clinical Pharmacology Lead (D-CPhL) is a senior level Clinical Pharmacologist at Boehringer Ingelheim Pharmaceuticals Incorporated. The ultimate intent of this role is to build understanding of diseases and drugs through the development and implementation of innovative translational strategies across the entire clinical development pipeline to be "first4patients". The D-CPhL supports the clinical drug research and development process by strategic planning of Clinical Pharmacology data generation and by developing and implementing Clinical Pharmacology strategies (e.g., assessment of pharmacokinetic/pharmacodynamic (PK/PD), drug interaction, formulation development, dose selection decision, impact of renal/hepatic impairment, food effect on PK, QT prolongation and pediatric drug development).

The Director, Clinical Pharmacology Lead (D-CPhL) acts as representative in project teams for complex clinical development projects. The incumbent will lead complex clinical development overarching topics with various interfaces and stakeholders as well as will provide Clin Pharm expert advice and functional expertise (internally and externally recognized expert with a proven track record of significant contributions to BI assets). The D-CPhL is an internally and externally recognized expert in Clinical Pharmacology (CP) based not only on expert knowledge and engagement but also leadership style (matrix teams) and several years of relevant experience (for instance, authority interactions, successful regulatory submissions, and label negotiations among others).

Post PoCP, by default D-CPhL will be the TMCP integrator representing the various functions from TMCP in various clinical project teams until submission and launch. The incumbent will lead the Clinical Pharmacology and Biomarkers Integration team for their project.

The Director, Clinical Pharmacology Lead (D-CPhL) supports all tasks that are performed by the Senior Associate Director/Associate Director (See respective job profiles). The incumbent will continuously and consistently develop, implement, and promote innovative clinical pharmacology methodologies/approaches and provide consultancy and expert advice for junior CPhL colleagues and Trial Clinical Pharmacologists (TCPs; see TCP job profile). This role trains TCPs and CPhLs on various scientific matters.

• Preferred as CP representatives to various initiatives and working groups within BI and externally (for instance, due diligence and in-licensing activities).
• Expected to provide consultancy and expert advice to TCPs and junior CPhLs on critical and complex CP questions.
• Continuously and consistently develop, implement, and promote innovative clinical pharmacology methodologies/approaches to help ensure that work done in CP group is consistent with the most current scientific understanding in the field.
• Trains TCPs and junior CPhLs on various scientific matters.

• Ensures timely delivery of state-of-the-art Clin Pharm scientific concepts, data measurements and analyses for decision making throughout clinical drug development and registration including all necessary processes and documentation, also for complex clinical development projects that represent new challenges (e.g., new modalities, indications, etc.).
• Ensures timely delivery of state-of-the-art Clin Pharm strategy development and implementation, also for projects that represent new challenges (e.g., new modalities, indications, etc.).

• Acts as representative in project teams for complex projects and regulatory meetings including advisory boards.

• Leads complex clinical development project overarching topics from TMCP.
• Leads internal and external initiatives/working groups.
• Continuously scouts, evaluates (incl piloting) and implements new Clin Pharm methods and strategies.
• In alignment with functional head, represents Clinical Pharmacology at internal as well as external meetings and committees and panels.

• Systematically identifies and implements collaborations and strategic partnerships with external bodies.
• Organizes and manages projects with external organizations (e.g., CROs, ARO).

• Leads development and refinement of further…