Clinical Pharmacologist/Pharmacometrician

Job Title: Clinical Pharmacologist/Pharmacometrician

Location: Waltham, MA (USA) or Gaithersburg, MD (USA)
 

As a the Clinical Pharmacologist/Pharmacometrician playing a hybrid role on our exciting AZ portfolio and primarily responsible for the study related Clinical Pharmacology activities in Oncology drug development and conducts pharmacometrics, population based analyses for the assigned projects. This position requires strong collaboratively approach with other scientists within and external to CPQP as well as cross functionally with other groups within AstraZeneca including medical, biostatistics, regulatory, and translational medicine. The candidate will support the Oncology programs from early pre-IND through first submission using the concepts of MIDD  to support drug development and interactions with world health authorities.

Responsibilities:

• Accountable for the conduct of Clinical Pharmacology and model-informed drug development scientific activities and help in input into clinical development plans across diverse modalities.

• Lead pharmacometrics activities in end-to-end drug development using MIDD

• Hands on experience with population based modeling, ER/ES analyses and meta-analyses desireable

• Represent CPQP on clinical development teams and health authority interactions, as needed

• Contribute and Author relevant sections of clinical study protocols, in a matrix environment by working closely with clinical development teams

• Conduct submission related activities and manage contributions of functions, including clinical pharmacology, pharmacometrics, statistical sciences, drug metabolism and pharmacokinetics, biopharmaceutics, and bioanalytical/biomarkers

• Interact with world health authorities (experience preferred) for Oncology projects

• Collaborative authoring experience highly preferred to support writing, review and approval of clinical documents including IB, CSR, PIP, PSP, marketing application sections, health authority briefing documents, and regulatory responses

• External presentations and publications is desireable

• Participation in Departmental initiatives, site activities, and cross-functional teams as need arises

Prior experience: 

• Advanced degree (Ph.D. or PharmD) with 1-3 years of drug development experience preferred.

Special Skills/Abilities:

• Fundamental understanding of the drug development processes from IND through mid to late stages of clinical development desireable

• Prior experience in Clinical Pharmacology, PK-PD modeling and Pharmacometrics in the Oncology therapy area

• Oncology drug development experience desireable

• Team player  and ability to work in a highly matrixed team environment.

• The ability to adapt and influence clinical outcomes using quantitative modeling approaches.

• Ability to deliver effective presentations and excellent written/oral communication highly preferred.

• Thrives in a fast-paced business environment.
   

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives 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.
 

At AstraZeneca, we are committed to making a difference by fusing data and technology with scientific innovation. Our curiosity and courage drive us to explore new possibilities in treating complex diseases. We work seamlessly as one team, leveraging diverse global knowledge to create impactful solutions. With opportunities for continuous learning and growth, we push the boundaries of science to deliver life-changing medicines.
 

Ready to make an impact? Apply now and join us on this exciting journey!

The annual base pay (or hourly rate of compensation) for this position ranges $135,457.60 - 203,186.40 USD Annual.  Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opp