Associate Director/Director, Clinical Pharmacology
Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition, Alnylam has four investigational medicines in late-stage development. www.alnylam.com. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015, 2016, 2017 and 2018- four years in a row!
The Associate Director/Director in clinical pharmacology position will support a rapidly expanding clinical portfolio of promising RNAi therapeutics. Currently there are 5 products in phase 3 development and an active mid-stage clinical and preclinical pipeline that produces approximately 3 additional new clinical programs annually. The candidate in this key position will be responsible for clinical PKPD, clinical pharmacology strategic and tactical aspects on project teams. In this role, the candidate is expected to have a strong regulatory and scientific foundation pertaining to drug development and play an active role on the program team. The candidate is expected to conduct PK/PD analyses to guide decision making on the project teams.
Summary of Key Responsibilities
Represent PK and provide PKPD support and guidance to clinical stage project teams.
Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data
Conduct PK/PD analyses to guide development decisions on project teams
Develop model-based justifications for optimal doses selected for pivotal clinical trials, while working in close partnership with pharmacometrics, clinical Development and statisticians.
Develop an understanding of the relationship between clinical data and preclinical findings to inform individual development programs as well as broader technology platform research initiatives.
Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA.
Design and oversee the conduct of clinical pharmacology studies (either standalone or within broader clinical trials) to generate high quality and relevant data.
Network with external expert consultants, CRO partners and academic sites to problem solve and develop scientific solutions to clinical pharmacology issues.
Lead and prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data
Participates in the preparation of abstracts and manuscripts for publication
Closely partner with Research, Bioanalytical, Clinical functions, Regulatory, Project Management, and other R&D functions.
Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 3-8 years' experience in pharmaceutical industry, or M.D or Pharm.D. with equivalent experience
Strong working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology.
Ability to independently interrogate results and provide actionable guidance
Proficient in using Phoenix WinNonlin, NONMEM, or other pharmacokinetic and modeling software.
Strong communication skills (verbal and written) and presentation skills are required. Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential.
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
Alnylam Pharmaceuticals, Inc.