Global Clinical Pharmacology Lead

Global Clinical Pharmacology Lead

About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

About This Job

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.

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.

You will be part of an inclusive team that works to develop innovative therapies for patients.

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.

Essential Knowledge & Experience

• 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 fellowship in clinical pharmacology or equivalent.

Additional Information

• Type of role full time permanent.
• Location UK (Addlestone).
• This position follows our hybrid working model. The role requires a blend of home and minimum 1 day per month in our UK office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

What We Offer

• A challenging and diversified job in an international setting.
• Opportunity and support for continuous development.
• Inspiring work climate.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.