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Executive Director, Pharmacometrics

Executive Director, Pharmacometrics

Alnylam PharmaceuticalsCambridge, MA, United States
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Overview

Seeking an experienced Head of Pharmacometrics to expand Clinical Pharmacology and Pharmacometrics capabilities within Alnylam.

The Executive Director, Pharmacometrics is a on-site, leadership role focused on providing strategic direction, team management, and execution of pharmacometric activities within Alnylam. This role involves guiding the development and application of modeling and simulation strategies to support decision making in drug development and regulatory submissions. A robust and rich experience in applying pharmacometric analysis supporting Phase 1-3 clinical development is preferred. The Executive Director, Pharmacometrics will partner with key stakeholders within research, early development, clinical development and regulatory for successful delivery of Alnylam Development portfolio.

Responsibilities

  • Develop and implement pharmacometric strategies across drug development, including dose selection, study design, and lifecycle management.
  • Provide scientific modeling based input in interpretion and translation of preclinical information to clinical for novel indications and target tissues
  • Lead and mentor a team of pharmacometricians, ensuring their professional development and providing guidance on complex analyses
  • Partner with cross-functional teams (early development, clinical research, clinical pharmacology, biostatistics, regulatory affairs) to advance Alnylam portfolio against program goals.
  • Lead the development and application of pharmacometric models to support dosing decisions, optimize trial designs, establish proof of concept and optimize clinical trial success.
  • Engage with regulatory agencies and prepare and review pharmacometric reports and regulatory submission documents.
  • Stay current with advances in pharmacometrics and share expertise within the organization.

Qualifications

  • PhD or equivalent in clinical pharmacology, pharmacokinetics, or pharmacometrics
  • 10+ years of pharmaceutical industry experience in drug discovery and development
  • Expert knowledge of PK / PD, QSP and pharmacometric analyses
  • Proficient in using modeling software such as R, NONMEM, SAS, MATLAB
  • Ability to manage multiple programs
  • Excellent problem solving skills with a strong innovative spirit
  • Strong leadership and interpersonal skills with experience managing a team of pharmacometricians
  • Excellent oral and written communication skills
  • Experience with writing Clinical Pharmacology and Pharmacometrics documents supporting regulatory submissions
  • U.S. Pay Range

    $289,000.00 - $391,000.00

    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

    AboutAlnylam

    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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