Director Clinical Pharmacology and Quantitative Pharmacology
Director Clinical Pharmacology and Quantitative Pharmacology
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Salary Not Disclosed
1 Vacancy
Job Description
The Director CPQP position resides within Alexions Clinical Pharmacology and Safety Sciences (CPSS) organization. As the CPQP lead you will provide subject matter expertise and programlevel functional and operational leadership to the global development team(s) on all issues related to CPQP! You will develop and manage assorted clinical pharmacology (CP) and quantitative pharmacology (QP) plans and modelinformed drug development strategies as appropriate (population analyses exposureresponse PBPK etc). Representing the CPQP function on drug development teams leading CPQP subteams and owning strategy and delivery on posology for early and latestage clinical trials while collaborating with clinicians clinical operations bioanalytical biomarker pharmacovigilance regulatory and CMC groups will be key responsibilities. This role requires strong communication and interpersonal skills and involves leading a team of scientists to develop and manage clinical pharmacology plans and exposure response analyses for compounds from earlystage (preclinical to firstinhuman up to proofofconcept) to latestage clinical development (proofofconcept up to postmarketing approval).
Accountabilities
- Represent CPQP function at the Global Project Team and lead CPSS subteam.
- Lead the development of the clinical pharmacology (PK PD biomarkers Bioanalytical) sections of early and latestage clinical protocols Clin Pharm development plans and assorted QP analysis plans.
- Contribute to the preparation of the preIND IND IB and IMPD documents.
- Design early phase clinical trials (FIH to POC) and support project goals.
- Set starting dose in trials using scaling or modeling; evaluate exposure vs. response data for dosing decisions.
- Design latestage clinical trials (POCBLA/NDA) and support project goals.
- Prepare PK/PD reports/sections of clinical study reports.
- Provide clinical pharmacology input and collaborate across all areas of drug development.
- Deliver pharmacokinetic/pharmacodynamic data analyses using standard industry data analysis software.
- Deliver clinical pharmacology components of clinical study protocols and clinical study reports.
Essential Skills/Experience
- Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology pharmacology/cell biology/immunology or relevant field.
- At least 10 years of postdoctoral experience in supporting pharmacokinetics pharmacodynamics and other CP and QP components of early and latestage clinical trials.
- Knowledge of data analysis methodologies for implementation in analyzing early and latestage clinical phase data including applying modelinformed drug development (MIDD) strategies to advise program decisionmaking.
- Knowledge of general regulatory process and experience in contributing to IND EOP1 EOP2 and preBLA/NDA meetings with the FDA and EMA.
- Excellent written and oral communication skills including good presentation skills. Prior multidisciplinary teamfacing experience in a CPQP role is preferred.
- Strong eye for business; including knowledge of the multidisciplinary functions involved in a companys drug development process e.g. clinical operations research biostatistics clinical pharmacology regulatory commercial operations etc. and can proactively integrate multiple perspectives into the clinical development process for the best endresults.
Desirable Skills/Experience
- Experience with Genetic Medicine development is preferred
When we put unexpected teams in the same room we ignite bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZenecas Alexion division you will find a patientdriven culture where diversity is valued inclusion is championed and new ideas are celebrated. Our commitment to innovation means you will be part of a team that is making a real difference in patients lives. We offer tailored development programs designed to enhance your skills while fostering a deep understanding of our patients journeys. Our supportive community of leaders and peers is dedicated to helping you succeed.
Ready to make an impact Apply now to join our team!
Date Posted
10Apr2025Closing Date
29Jul2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in EVerify.Required Experience:
Director
Employment Type
Full-Time
