Sr. Scientist, Clinical Pharmacology
Alnylam Pharmaceuticals
19 days ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Represent Clinical Pharmacology and provide PKPD support and guidance to early and clinical stage project teams.
- Lead analysis, interpretation, integration, and reporting of clinical pharmacokinetic & pharmacodynamic data.
- Conduct PK/PD analyses and data visualization to guide development decisions; use model-based approaches to aid decision making.
- Provide PKPD input for regulatory submissions (briefing documents, IND, CTA, NDA).
- Contribute to protocol preparation, study execution, data review/analysis, study reports, and regulatory document preparation.
- Partner closely with Research, Bioanalytical, Clinical development, Regulatory, Project Management, biostatistics, and other R&D functions.
- Maintain current knowledge of clinical pharmacology, modeling, and simulation literature.
Qualifications:
- Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics, or related field with 2–3 years’ pharmaceutical industry experience; or M.D./Pharm.D. with equivalent experience. Level depends on experience and interpersonal skills.
- Strong knowledge of clinical pharmacology in drug development (PKPD, modeling/simulation, ADME, clinical pharmacology).
- Hands-on experience with R and data visualization techniques for PKPD data.
- Proficient with Phoenix WinNonlin, Phoenix NLME, R, NONMEM, or other pharmacokinetic/modeling software; training in pharmacometrics principles/software a plus.
- Strong verbal/written communication and presentation skills; strong collaboration in a highly matrixed environment.
- Represent Clinical Pharmacology and provide PKPD support and guidance to early and clinical stage project teams.
- Lead analysis, interpretation, integration, and reporting of clinical pharmacokinetic & pharmacodynamic data.
- Conduct PK/PD analyses and data visualization to guide development decisions; use model-based approaches to aid decision making.
- Provide PKPD input for regulatory submissions (briefing documents, IND, CTA, NDA).
- Contribute to protocol preparation, study execution, data review/analysis, study reports, and regulatory document preparation.
- Partner closely with Research, Bioanalytical, Clinical development, Regulatory, Project Management, biostatistics, and other R&D functions.
- Maintain current knowledge of clinical pharmacology, modeling, and simulation literature.
Qualifications:
- Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics, or related field with 2–3 years’ pharmaceutical industry experience; or M.D./Pharm.D. with equivalent experience. Level depends on experience and interpersonal skills.
- Strong knowledge of clinical pharmacology in drug development (PKPD, modeling/simulation, ADME, clinical pharmacology).
- Hands-on experience with R and data visualization techniques for PKPD data.
- Proficient with Phoenix WinNonlin, Phoenix NLME, R, NONMEM, or other pharmacokinetic/modeling software; training in pharmacometrics principles/software a plus.
- Strong verbal/written communication and presentation skills; strong collaboration in a highly matrixed environment.