Senior Director Clinical Pharmacology Lead

Senior Director Clinical Pharmacology Lead

The Clinical Pharmacology Lead (CPL) Oncology will bring an extensive experience and knowledge of the Clinical Pharmacology (CP) field for all phases of Oncology drug development projects. This position will play a key role in management of interactions with KOLs as well as with regulatory authorities will work closely with Pharmacokinetics specialists, Translational Sciences, Pharmacometrics, Research, Clinical Development, Regulatory, Medical Affairs and Commercial/Marketing functions. Ultimately, the position aims to optimize decisions on drug development projects (particularly the dosing strategy) and advance products to regulatory approval with a competitive and state-of-the-art product label.

The Clinical Pharmacology Lead builds an end-to-end clinical pharmacology strategy and is responsible for its successful execution for all development programs.

Together with cross-functional Program Team (PT) and Translational Science Team (TST) members, the Clinical Pharmacology Lead will complete all globally relevant Clinical Pharmacology activities from early research up to Life Cycle Management (LCM) in a time- and resource efficient manner, significantly shaping the value of the product. This individual will ultimately drive quantitative decision making, in so doing aiding objective assessment of the clinical assets and creating highly competitive drug labels.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities for this role Senior Director Clinical Pharmacology Lead are to:

• Independently represent Clinical Pharmacology (CP) Oncology in Product Teams (PTs) and related clinical teams;
• Anticipate and ensure adequate consideration and implementation of all aspects of CP, and Pharmacokinetics/Pharmacodynamics 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 PK/PD activities to support study design and dose / schedule selection for first-in-human and other exploratory clinical studies in close alignment with other functions within Red Onc as well as Toxicology, DMPK and Pharmacometrics;
• Provide in-depth subject matter advice 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. To be achieved in close collaboration with the respective Oncology Development / GMA functions and study teams;
• Closely interact with other functions within Research and Early Development Oncology (RED ONC) as well as within Oncology Development to define the best use pharmacology 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. Communicate clearly with internal and external parties to elicit these measures;
• 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. 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;
• 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;
• In alignment with the overall oncology strategy and Precision Medicine community, identify new opportunities for collaboration and manages excellent relationships with new and existing partners, both within as well as outside of Bayer, to drive clinical pharmacology excellence.
• Independently lead self-empowered matrix teams in-line with Bayer’s VACC (Visionary, Architect, Catalyst, Coach) leadership standards by enabling, empowering, and supporting colleagues in a high-performance environment under a culture of psychological safety. As such, takes accountability for the respective team outcomes and promotes a creative and innovation-friendly collaboration between clinicians and scientists;
• Take ownership, foster a culture of ownership in support of the strategy and in line with Bayer’s values; empower others and drive peer accountability across portfolio deliverables and beyond.

WHO YOU ARE

Required Qualifications:

• PhD, MD or PharmD;  
• Strong background and demonstrated expertise in Clinical Pharmacology, PK and Pharmacokinetic/Pharmacodynamic 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 of leadership skills to direct and steer a team of experts, awareness of responsibility, efficient analytical thinking and working methods;
• Capable of working independently, excellent communication and organizational skills;
• Ability to handle conflict, highly resilient.

Preferred Qualifications:

• PhD, MD or PharmD with at least 10 years extensive expertise in the area of Clinical Pharmacology and Oncology Drug Development. Of this, at least 6 years of experience must be in Pharmaceutical industry or equivalent (e.g., FDA).