Associate Director, Clinical Pharmacology

Associate Director Job description:

The Associate Director in Clinical Pharmacology position will support a rapidly expanding clinical portfolio of promising RNAi therapeutics. The candidate in this position should be well versed in clinical pharmacology, PK and PD with strong ability to critically evaluate and interpret data and conduct data analysis. In this role, the candidate is expected to have a strong critical thinking ability with good oral and written communication skills as well as worked independently in a highly matrixed environment.

Key Responsibilities

• Represent independently Clinical Pharmacology and provide clinical pharmacology support and guidance to clinical stage project teams.
• Lead the analysis, interpretation, integration and reporting of clinical pharmacology data
• Conduct PK and PK/PD analyses to guide clinical development decisions
• Provide clinical pharmacology input for regulatory submissions such as briefing documents, IND, CTA and NDA
• Prepare and input independently appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data
• Closely partner with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions
• Preparation of abstracts and manuscripts for publications
• Network with external expert consultants, CRO partners and academic sites to problem solve and develop scientific solutions to clinical pharmacology issues

Qualifications

• Ph.D. ( or  Pharm.D.) in relevant field (i.e. Pharmacokinetics, Pharmacometrics, Clinical Pharmacology) with at least 5 years’ experience in pharmaceutical/biotech industry
• In depth knowledge of clinical pharmacology, pharmacokinetics, modeling and simulation, PK/PD principles, ADME and clinical data interpretation
• In depth knowledge of international guidelines related to Clinical Pharmacology and Pharmacometrics
• Proficient in using Phoenix WinNonlin, R, NONMEM, or other pharmacokinetic, modeling and data visualizations software.
• Ability to function in a highly matrixed team environment is essential
• Ability to work independently
• Strong communication and presentation skills (verbal and written)
• Excellent interpersonal skills and ability to work independently
• Fluency in English (verbal and written) 

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 culture: 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 one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 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.