Alnylam Pharmaceuticals
The Sr. Scientist in Clinical Pharmacology will support a rapidly expanding clinical portfolio of RNAi therapeutics by providing PKPD support and guidance to project teams. The role involves analyzing, interpreting, integrating, and reporting clinical pharmacokinetic and pharmacodynamic data, conducting PK/PD analyses and data visualization, and contributing to regulatory submissions and study documentation.
Key Responsibilities
- • Represent Clinical Pharmacology and provide PKPD support and guidance to early and clinical stage project teams.
- • Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data
- • Conduct PK/PD analyses and data visualization to guide development decisions on project teams; ability to use model-based approaches to aid decision making
- • Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA.
- • Contribute to protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation
- • Closely partner with Research, Bioanalytical, Clinical development, Regulatory, Project Management, biostatistics and other R&D functions.
- • Maintain a current understanding of the literature and knowledge in the clinical pharmacology, modeling and simulation field
Required
- • Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 2-3 years’ experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience.
- • Strong knowledge of clinical pharmacology principles in drug development including PKPD, modeling and simulation, ADME concepts, and clinical pharmacology.
- • Hand-on experience in using R and other data visualization techniques for representation of PKPD data.
- • Proficient in using Phoenix WinNonlin, Phoenix NLME, R, NONMEM, or other pharmacokinetic, modeling software.
- • Strong communication skills (verbal and written) and presentation skills are required.
- • Excellent interpersonal and collaboration skills and the ability to function in a highly matrixed team environment are essential.
Preferred
- • Training in application of pharmacometric principles or software would be a plus.
Benefits & Perks
- • Comprehensive benefits including medical, dental, and vision coverage
- • Life and disability insurance
- • Lifestyle reimbursement program
- • Flexible spending and health savings accounts
- • 401(k) with a generous company match
- • Paid time off, wellness days, holidays, and two company-wide recharge breaks
- • Generous family resources and leave
Summary Of Key Responsibilities
- Represent Clinical Pharmacology and provide PKPD support and guidance to early and clinical stage project teams.
- Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data
- Conduct PK/PD analyses and data visualization to guide development decisions on project teams; ability to use model-based approaches to aid decision making
- Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA.
- Contribute to protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation
- Closely partner with Research, Bioanalytical, Clinical development, Regulatory, Project Management, biostatistics and other R&D functions.
- Maintain a current understanding of the literature and knowledge in the clinical pharmacology, modeling and simulation field
- Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 2-3 years’ experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience. Level and responsibilities will depend on the individual’s experience and interpersonal skills.
- Strong knowledge of clinical pharmacology principles in drug development including PKPD, modeling and simulation, ADME concepts, and clinical pharmacology.
- Hand-on experience in using R and other data visualization techniques for representation of PKPD data.
- Proficient in using Phoenix WinNonlin, Phoenix NLME, R, NONMEM, or other pharmacokinetic, modeling software. Training in application of pharmacometric principles or software would be a plus.
- Strong communication skills (verbal and written) and presentation skills are required. Excellent interpersonal and collaboration skills and the ability to function in a highly matrixed team environment are essential.
$131,800.00 - $178,300.00
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.
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