Director, Global Clinical Pharmacology, Biologics

Director, Global Clinical Pharmacology, Biologics

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:

The Director Clinical Pharmacology (Biologics) is a new role in which you will have ultimate accountability for Clinical Pharmacology from first-in-human through to approval, including post-marketing activities for assigned projects.

We are witnessing transformation across the globe in how healthcare is designed and delivered with an accelerating pace in innovation, allowing patient-centric decision-making and personalized medicine to become a reality. In Clinical Pharmacology and Translational Science, Astellas is proud to be at the forefront of innovation and change impacting patients’ lives like never before.

This is a great opportunity for you to join this team as an experienced Clinical Pharmacologist to deliver therapeutic optimization and individualization (the right dose for the right patient). You will apply state-of-the-art scientific principles to evaluate exposure-response relationships based on knowledge of drug disposition, pharmacology, disease biology, and patient population, alongside patient variability in Pharmacokinetics (PK) and the impact of immunogenicity

Hybrid working:

At Astellas we recognise that our employees enjoy having 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 are noted below:

• You will represent the department and provide subject matter expertise on cross-functional project teams in respect of candidate nomination (pre-initiation of GLP tox) through approval and post-marketing. Lead cross-functional sub-teams by the development stage to achieve Clinical Pharmacology goals
• Provide effective oversight of Clinical Pharmacology aspects of clinical trials (including study design, interpretation, and communication of results) in addition to authoring/reviewing clinical protocols, analysis plans, study reports and regulatory submissions
• Participate in cross-functional discussions and collaborate with individuals across disciplines, mentoring junior members
• Develop high-quality Clinical Pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs, diversity and pediatric plans
• Present Clinical Pharmacology aspects of the Global Clinical development program at internal and external meetings e.g., meetings with health authorities, at congresses and for investigator meetings

Essential Knowledge & Experience:

• Solid post-graduate experience from within the pharmaceutical industry and thorough knowledge of current/emerging scientific standards/global regulatory requirements
• Working knowledge of biomarkers, biologics/bioanalytical methods, and immunogenicity with a thorough understanding of early development, clinical methodologies, POC, and clinical endpoints. Expert knowledge of Clinical Pharmacology in drug development and experience of clinical dose setting (including first in human) alongside pharmacokinetic and pharmacodynamic relationships
• Fluent in verbal and written English with excellent written and oral communication skills with the ability to convey complex technical information clearly
• Experience of integrating modelling and simulation activities (population PK, exposure-response and physiologically based PK) to support the Clinical Pharmacology plan
• Adaptability and curiosity to learn new modalities and apply core Clinical Pharmacology principles to novel therapeutics. Able to work independently, create innovative solutions to presenting problems and influence senior leaders

Education/Qualifications:

• PhD or PharmD with a fellowship in Clinical Pharmacology or equivalent

Additional information:

• This is a permanent, full-time position that can be based in the UK, EU4, Belgium, or Netherlands.
• This position follows our hybrid working model. Role requires a blend of home and a minimum 1-day per quarter in the office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of their nearest office

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.