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Sr. Director, CPQP (Clinical Pharmacology & Quantitative Pharmacometrics)

Location Boston, Massachusetts, United States Job ID R-178228 Date posted 14/02/2024

This Senior Director, sits within Alexion’s Clinical Pharmacology and Safety Sciences (CPSS) organization. It is a hybrid role representing Non-Clinical and Clinical Pharmacology (NCCP) and Quantitative Pharmacology (QP) function line leadership and bringing NCCQP’s perspective to drug development and global medicine teams.

This role will encompass

1) both a biologic molecule’s clinical pharmacology program and implementing model-informed drug development (MIDD) strategies on behalf of the QP function,

2) designing and/or implementing, within the regulatory framework, from end of Phase 1 through Phase 4 NCCQP

3) ensuring NCCQP support and active participation in the key decisions at R&D governance milestones. This position will collaborate with Translational Medicine, Medical Sciences, Biostatistics, Research, and other colleagues within the Alexion/AZ Rare Disease Unit (RDU) organization.

You will be responsible for

  • Responsible for collaborating across all clinical development functions and overseeing the preparation of NCCP and QP deliverables including clinical protocols, pharmacometric analysis plans and relevant regulatory documents/sections.

  • Contribute to the design of clinical trials (FIH to Phase 3) and take ownership of designing and implementing NCCQP plans during development.

  • On behalf of the NCCQP sub-team:

    • Accountable for PK and PK/PD NCA outputs and inclusion in relevant documents

    • Accountable for population-PK, PK/PD outputs and timely delivery of reports and relevant sections of regulatory documents including, but not limited to, PIP and CTD modules.

    • Accountable for the updating of the clinical pharmacology sections of IND, IB, IMPD documents

  • Leverage hands-on effort, internal resources, and external vendors when needed; plan, design and complete model-based analyses for supporting dose selection, dose regimen optimization and determining probability of achieving positive results for clinical trials. 

We would like you to have

  • 15+ years of industry experience in Drug Development with expertise including Pharmacometrics, Non-Clinical/Clinical Pharmacology, or similar areas of expertise

  • Experience designing and implementing Clinical Pharmacology development plans and Modeling and Simulation plans during development.

  • Experience (hands on) with NONMEM or other nlme software, R, S+, and/or SAS (if no R or S+ experience).

  • Working knowledge in bioanalytical, biopharmaceutics, DMPK, safety pharmacology, immunogenicity and toxicology areas is a must

  • Expert knowledge of global regulations, regulatory guidance, ethical issues associated with clinical pharmacology and pharmacometrics is required

  • Experience in interacting with the regulatory agencies (drafting briefing documents, making in person presentations, defending company positions, and taking ownership of written responses) across the clinical development phases (pre-IND to post NDA/BLA submission) is required.

  • A track record of contributions to INDs, NDAs/BLAs, and various regulatory submissions.

  • A publication track record in peer-reviewed journals and scientific meetings, and a respected talent in pharmacometrics.

We would prefer for you to have!

A PhD degree or equivalent in a quantitative sciences field, background in engineering, mathematics, statistics, clinical pharmacology, or health sciences-related field

Working at Alexion!

The Highest Standards

By operating with the highest standards of ethics and integrity, we aspire to live up to the expectations of patients, physicians, and ourselves, and to earn trust in our communities.

Diversity

We encourage diversity of backgrounds and ideas. We genuinely care for and respect each other, working together as a high-performing team to deliver extraordinary results while embracing different perspectives.

Dedication

The dedication and passion of our employees enable us to stay focused on what matters most. We push ourselves to achieve the highest level of medical innovation, and to redefine what it means to live with a rare disease.

Hybrid Work

Expectation of working in the office 3 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. 

Vaccination

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Commitment to Diversity!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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