Associate Director, Clinical Pharmacology

Alnylam Pharmaceuticals; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

The Associate Director in Clinical Pharmacology at Alnylam Pharmaceuticals will support a rapidly expanding RNAi CNS portfolio, bringing deep expertise in PK/PD modeling, data interpretation and clinical pharmacology to project teams. You will lead analyses, interpret results, and prepare regulatory documents while collaborating with Research, Regulatory, and Clinical groups in a highly matrixed environment.

Strong communication and independent work are essential.

Qualifications

• Ph.D. or Pharm.D. in pharmacology or related field with deep industry experience.
• In-depth knowledge of clinical pharmacology, PK/PD, modeling and data interpretation.
• Proficient in pharmacometrics tools (Phoenix WinNonlin, NONMEM, R) and data visualization.
• Ability to work independently in a highly matrixed team environment.
• Strong verbal and written communication and presentation skills.
• Fluency in English (verbal and written).

Responsibilities

• Represent Clinical Pharmacology and support clinical stage project teams.
• Lead analysis, interpretation, integration and reporting of clinical pharmacology data.
• Conduct PK and PK/PD analyses to guide clinical decisions.
• Provide pharmacology input for regulatory submissions (IND, NDA, etc.).
• Prepare sections of protocols, Investigator Brochures and Clinical Study Reports.
• Collaborate with Research, Regulatory, Clinical, and Project Management functions and publish work.

Skills

Clinical pharmacology

PK/PD analysis

Data interpretation

Independent in matrixed env

Communication skills

Education

Ph.D. or Pharm.D.

Tools

Phoenix WinNonlin

R

NONMEM

Job description

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.

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

We are the leader in RNAi therapeutics– a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

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