Agios (agios.com) is a biopharmaceutical company focused on providing medicines for some of the world’s most challenging diseases. We’re committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the pyruvate kinase (PK) platform. Agios is leading the way in advancing PKR activation for hemolytic anemias, including PK deficiency, thalassemia and sickle cell disease, and has demonstrated a strong commitment to these patient communities. We continue to foster a productive research engine that yields new insights and potential therapeutic approaches. We’re a company that cares about our work, each other, and the people who are counting on us the most. We’re inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results. We’re driven to be our best selves, together, so we can reach for the Other Side of Possible.

Agios Pharmaceuticals is searching for a dynamic Senior Scientist/Associate Director to join our growing DMPK team. This is a unique opportunity for an aspiring scientist to contribute to the discovery and development of medicines on both preclinical and clinical sides. The incumbent will be responsible for representing DMPK on Discovery and clinical development teams. The candidate should have a strong understanding of ADME, PKPD and clinical pharmacology principles. The individual should have demonstrated experience leading discovery projects as a DMPK representative and/or development projects as a clinical pharmacologist. The qualified candidate is expected to establish and develop strong relationships across deeply expert functional partners and possess excellent communication and interpersonal skills. Following our recent two successful Phase III studies in PK deficiency, and demonstration of proof of concept for PK activation in several hemolytic anemias, our understanding of the complex red blood cell pharmacodynamics, cellular pharmacology/metabolism and population exposure-response modeling, provide an extremely fertile ground for honing your discipline in Genetically Defined Diseases.

Key Responsibilities

• Independently represent DMPK function as a core member of program teams, development sub-teams, clinical trial working groups
• Responsible for leading the scientific, technical and operational efforts of DMPK for Discovery projects
• Drive internal and external DMPK activities, including routine PK studies, biotransformation and transporter studies, troubleshooting, and issue management 
• Participate in writing IND documentation  
• Manage and execute clinical pharmacology deliverables in collaboration with internal and external partners in an efficient and scientifically rigorous manner 
• Design, execute, perform PKPD analysis, interpret and report findings from clinical pharmacology-related studies including first-in-human, drug interaction, biopharmaceutics, and mass balance studies
• Develop overall clinical pharmacology strategy to align with clinical development plans; contribute to clinical trial designs, author protocols, coordinate trial conduct and finalize study reports within agreed timelines and meeting regulatory requirements 
• Manage CROs for clinical pharmacology-related studies and activities for developing study timelines, objectives and budgets; ensuring accuracy of project progress and completion and pro-actively identifying hurdles and providing solutions
• Present and publish internally and externally as main contributor to enhance visibility of Agios’ DMPK department 

Minimum Requirements

• Education: PhD or PhD accompanied with post-doctoral training in clinical pharmacology, pharmaceutical sciences or related areas such as pharmacokinetics, pharmacology or drug metabolism

• 5-to-8 years’ experience in the pharmaceutical industry

Working knowledge and/or previous experience in ADME, biotransformation, transporters, drug-drug interactions and PKPD modeling

• Hands-on knowledge of WinNonlin for PKPD analysis
• Experience working with CROs
• Must excel at working in a highly collaborative matrix team environment, have good organizational, communication (oral and written), and interpersonal skills
• Must be able to work independently

Preferred Qualifications

• IND/other regulatory filing experience
• Broad familiarity with drug development 
• Working knowledge of bioanalysis, data management and statistical programming
• Prior experience in conducting clinical pharmacology studies including study design, PKPD data analysis and/or population PK analysis, and result interpretation
• Advanced training in R, SAS, NONMEM and/or Monolix