Global Clinical Pharmacology Lead

As the Director Global Clinical, Pharmacology, you hold ultimate responsibility and accountability for navigating the entire clinical pharmacology journey, from the initiation of first-in-human trials to approval and subsequent post-marketing activities for the projects under your purview. Your role involves the optimization and individualization of therapeutics, ensuring the right dose for the right patient. This is achieved by employing state-of-the-art scientific principles and a quantitative framework, such as Model-Informed Drug Development (MIDD). Your expertise lies in evaluating exposure-response relationships, drawing upon a comprehensive understanding of drug disposition, pharmacology, disease biology, patient population characteristics, the competitive landscape, background therapy considerations, patient variability in pharmacokinetics and responses, formulation effects, and the impact of immunogenicity. You will be part of an inclusive team that works to develop innovative therapies for patients. Hybrid Working: At Astellas, we recognise that our employees enjoy having a balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office. Key Activities for this role:

• Representing the department and providing subject matter expertise on cross-functional project teams starting with candidate nomination (pre-initiation of (GLP tox) Good Laboratory Practice Toxicology) through approval and post marketing.
• Leading cross-functional sub-teams necessary by phase of development to achieve Clinical Pharmacology goals.
• Providing effective oversight of clinical pharmacology aspects of clinical trials (including study design, interpretation and communication of results) .
• Participating in cross-functional discussions and collaborating with individuals across disciplines; mentoring junior members.
• Reviewing clinical protocols, analysis plans, study reports and regulatory submissions
• Developing high quality clinical pharmacology plans and content for global regulatory submissions.
  
  Extensive professional experience in the pharmaceutical industry.
• Working knowledge of assigned therapeutic area, biomarkers, bioanalytical methods, immunogenicity.
• Have thorough understanding of early development, clinical methodologies, POC, and clinical endpoints within a specific therapeutic area.
• Expert knowledge of clinical pharmacology in drug development, with a strong scientific and strategic mindset and experience with clinical dose setting (including first in human dose setting) and pharmacokinetic/pharmacodynamic relationships
• Experience integrating modelling and simulation activities (i.e., population (PK) pharmacokinetics, exposure-response and physiologically based PK) to support the clinical pharmacology plan.
Educations/Qualifications:
• PhD or PharmD with a fellowship in clinical pharmacology or equivalent.
  
  At Astellas, experience is coupled energised with a relentless challenger spirit.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. We are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation. We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers. We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients., At Astellas, we believe that nurturing exceptional relationships with our employees delivers exceptional results. We can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It's a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit. For more information about our current career opportunities and how you can make a difference please visit https://www.astellas.com/eu/careers