Senior Director, Clinical Pharmacology Lead - CVRI

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Senior Director, Clinical Pharmacology Lead - CVRI 

The Senior Director, Clinical Pharmacology Lead (CPL) in Early Clinical Development (ECD) will deliver comprehensive Clinical Pharmacology knowledge and expertise throughout all phases of development projects, ranging from pre-PCC to post-marketing authorization. The CPL will act as a subject matter expert, providing program-level functional and operational leadership to global development teams on all aspects related to Clinical Pharmacology.

In this role, the CPL will also be responsible for providing and coordinating clinical pharmacology contributions to product dossiers (eCTD, NDA) to create a competitive label.

The CPL will develop and execute clinical pharmacology (CP), pharmacokinetic/pharmacodynamic (PK/PD) plans and model-informed drug development strategies (MIDD), as appropriate, including population analyses, exposure-response assessments, and PBPK modeling. The CPL represents the ECD function on Research and Product teams (RT and PT), leading cross-functional CP subteam, and overseeing the CP strategy and execution of posology for early and late-stage clinical trials. This will involve collaboration with clinicians, clinical operations, bioanalysis, biomarker specialists, pharmacometrics, pharmacovigilance, regulatory affairs, statistics, and PS (CMC) groups.

Each CPL is responsible for significantly enhancing technical excellence within RED CVRI by driving core projects, fostering innovation, and nurturing talent within a peer-reviewed environment, while also advancing the field of clinical pharmacology in close collaboration with both internal and external partners.

YOUR TASKS AND RESPONSBILITIES

The primary responsibilities of the Senior Director, Clinical Pharmacology Lead are:

• Independently represent ECD/Clinical Pharmacology (CP) in Research, Product Teams (RT, PT) and relevant sub-teams; and the lead the cross-functional CP sub-team.
• Design, execute, and coordinate the CP, PK/PD and MIDD strategies, aligning core CP studies with the overall development and submission plan for assigned projects.
• Drive the dose-range and dose selection strategy from pre-PCC until phase 3.
• Lead and manage the preparation of the CP sections of major clinical and regulatory documents (e.g. CTDs, NDAs, INDs, IMPDs) and provide global CP submission support for all countries / regions including the US, Europe, Japan, Asia Pacific, Canada and Latin America.
• Lead the development of the clinical pharmacology (PK, PD, biomarkers, bioanalytical) sections of early and late-stage clinical protocols.
• 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.
• Collaborate with other functions within RED-CVRI and Clinical Development & Operations (clinicians, clinical operations, data management, pharmacometrics, medical writing statistics), pharmacovigilance, PS (CMC), regulatory affairs to best use CP concepts including modeling and simulation approaches for development projects.
• 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.
• Proactively engages with other CPLs, identifies ways to advance skills and ways of working in the department.
• Represent ECD/CP externally, such as in meetings with authorities or key opinion leader (KOL) meetings; actively seeks opportunities to represent Bayer in various external forums and panels (such as industry consortia, government-industry panels, professional societies, and patient-focused groups).
• Independently lead self-empowered matrix teams in-line with Bayer’s VACC (Vi