Senior Scientist, Clinical Pharmacology

Work Category - hybrid

Description

Overview

The Senior Scientist, Clinical Pharmacology position will support a rapidly expanding

clinical portfolio of promising RNAi therapeutics. The candidate in this position should be well

versed in PK and PD with strong ability to critically evaluate and interpret data, conduct

noncompartmental analysis, and PKPD modeling. In this role, the candidate is expected to have

a strong critical thinking ability with good oral and written communication skills.

Summary of Key Responsibilities

• Represent Clinical Pharmacology and provide PKPD support and guidance to clinical stage project teams.
• Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data
• Conduct PK / PD analyses to guide development decisions on project teams
• Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA.
• Prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data
• Preparation of abstracts and manuscripts for publication
• Closely partner with Research, Bioanalytical, Clinical functions, Regulatory, Project Management, and other R&D functions.

Qualifications

Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with some experience in pharmaceutical industry, or M.

D or Pharm.D. with equivalent experience.

• Working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology.
• Proficient in using Phoenix WinNonlin, R, NONMEM, or other pharmacokinetic, modeling and data visualizations software.
• Strong communication skills (verbal and written) and presentation skills are required. Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential.

About Alnylam

Alnylam Pharmaceuticals (Nasdaq : ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases.

Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease.

Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our people-first culture is guided by our core values : fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make.

Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential.

By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.