Associate Director, Clinical Pharmacology

Associate Director, Pharmacometrics

Position Summary

Develop and execute population PK, PK/PD, exposure response, disease progression models, dose selection for phase 3 strategies/plans and corresponding models for the pharmacometric function from early clinical studies through Phase 3 study

• The incumbent will be responsible for the preparation of population PK/PD analysis plan, reports, and corresponding regulatory submission documents. The incumbent will be expected to manage multiple development projects simultaneously and will participate in discussions and presentations with senior management.

Key Responsibilities:

• As the M&S project lead on one or more cross-functional development teams, develop and execute M&S strategies and plans fully integrated with the overall preclinical and clinical plans;
• By using state of the art M&S methodologies strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with DMPK, Stat, Clin Pharm, Medical Sciences, Research, and other quantitative disciplines;
• Perform population PK, PK/PD analyses, clinical trial simulations and other model-based analyses when appropriate;
• Strengthen and build internal M&S capability on a continuous basis by attending trainings, evaluating and introducing new M&S tools and computing platform as appropriate;
• Prepare population PK/PD reports and corresponding regulatory submission documents.

Qualifications:

• A PhD, degree or equivalent in quantitative sciences, background in engineering, or clinical pharmacology is desired.
• 5+ years pharmaceutical industrial and/or postdoctoral experiences in the related disciplines of clinical pharmacology, and PKPD
• Excellent hands-on knowledge in R and/or SAS, NONMEM;
• Well versed at plotting complex data to identify trends important for drug development;
• Track record of publishing M&S work;
• Excellent written and verbal communication skills;

#LI-AB1 #LI-Hybrid

U.S. Pay Range

$175,800.00 - $237,800.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach 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 possible and 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, where an authentic, inclusive culture and breakthrough thinking fuel 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.