Associate Director, Clinical Pharmacology

Alnylam Pharmaceuticals, Inc.; Maidenhead; Hybrid; GBP 120,000 - 190,000; Full time

Job summary

Alnylam Pharmaceuticals seeks an Associate Director, Clinical Pharmacology to lead data analysis and interpretation for a growing RNAi portfolio in CNS. This virtual UK-based role requires expert PK/PD knowledge, strong communication, and the ability to work independently in a matrixed environment.

The candidate will lead pharmacology analyses, contribute to regulatory submissions, and collaborate with research, regulatory, and development teams to advance programs from early development through

Qualifications

• Ph.D. or Pharm.D. in Pharmacology with in depth industry experience.
• In depth knowledge of clinical pharmacology, PK/PD, modeling & simulation, ADME.
• Familiarity with international guidelines for Clinical Pharmacology & Pharmacometrics.
• Proficient in Phoenix WinNonlin, R, NONMEM or similar tools.
• Ability to work in a highly matrixed team and to communicate effectively.
• Fluency in English (verbal and written).

Responsibilities

• Lead analysis, interpretation, integration and reporting of clinical pharmacology data.
• Represent Clinical Pharmacology in cross-functional clinical stage teams.
• Conduct PK/PD analyses to guide development decisions.
• Support regulatory submissions (IND, CTA, NDA) with input for documents.
• Prepare protocols, Investigator Brochures and Clinical Study Reports.
• Collaborate with Research, Regulatory, Project Management and other functions.
• Prepare abstracts and manuscripts for publications.

Skills

Clinical pharmacology

Pharmacokinetics

Pharmacometrics

PK/PD

Education

PhD or PharmD in Pharmacology

Tools

Phoenix WinNonlin

R

NONMEM

Job description

Associate Director, Clinical Pharmacology

The Associate Director in Clinical Pharmacology position will support a rapidly expanding clinical portfolio of promising RNAi therapeutics in CNS. 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.

This is a virtual role based in the UK.

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

Qualifications

• Ph.D. ( or Pharm.D.) in relevant field (i.e. Pharmacokinetics, Pharmacometrics, Clinical Pharmacology) with in depth 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.