Agios 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.
The DMPK, Clinical Pharmacology Department at Agios is seeking a dedicated clinical pharmacologist to support genetically defined disease programs that are in early to late stages of clinical development.
The individual selected for this position is expected to represent the department independently on clinical study teams providing clinical pharmacology support on assigned studies.
This individual will take the lead on clinical programs.
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.
The qualified candidate will be responsible for managing and executing clinical pharmacology deliverables in collaboration with internal and external partners in an efficient and scientifically rigorous manner.
This individual will be accountable for the design, execution, PKPD analysis, interpretation and reporting of clinical pharmacology related studies including but not limited to first-in-human, drug interaction, biopharmaceutics and mass balance studies.
This will be accomplished by working in close partnership with senior clinical pharmacologists and other DMPK colleagues.
The qualified candidate is expected to establish and develop strong relationships with key cross functional partner functions such as clinical operations, clinical development, biostatistics, data management, medical writing, regulatory, safety and technical operations and therefore must possess excellent communication and interpersonal skills.
Remote candidates are welcome to apply!
Key Responsibilities
- Independently represent DMPK, Clinical Pharmacology as a core member of clinical trial working groups (CTWG):
- Contributing to clinical trial designs
- Authoring clinical study protocols
- Executing and coordinating clinical trial conduct
- Finalizing clinical study report
- All of this to be performed within agreed timelines and meeting all regulatory requirements.
- Develop and execute program specific Clinical Pharmacology strategy and plan.
Align plans with cross functional teams, study teams, and DMPK/Clinical Pharmacology senior staff
- Manage CROs for clinical pharmacology related studies and activities including: Developing study timelines, objectives, and budget, ensuring accuracy of project progress and completion, pro-actively identifying hurdles and providing solutions.
- Analyze and interpret PK/PD data generated during conduct of the clinical trials
- Communicating results and impact of results in a timely and effective manner to clinical study teams and development sub-teams.
- Lead internal DMPK sub-teams to define DMPK strategy for compound development.
- Actively participate in cross-departmental teams, department-wide initiatives and work streams.
- Present and publish internally and externally as main contributor to enhance visibility of Agios’ DMPK, Clinical Pharmacology department.
- Complete all required organizational trainings and requirements according to corporate timelines and adhere to the appropriate SOP and GxP guidelines.
Minimum Requirements
- Education: PhD accompanied with post-doctoral training in clinical pharmacology, pharmaceutical sciences or related areas such as pharmacokinetics, pharmacology or drug metabolism.
- At least 6-10 years of relevant experience in clinical drug development, 4+ years working as a clinical pharmacologist.
Level is flexible, exact level and responsibilities will depend on the individual’s experience and interpersonal skills.
- Experience conducting clinical pharmacology studies including study design, PKPD data analysis and/or population PK analysis, and result interpretation is required.
- A working knowledge and previous experience, either in the industry or as part of the educational training, with pharmacokinetic/pharmacodynamics, drug metabolism, drug-drug interactions, and population PKPD modeling is required.
- Must excel at working in a highly collaborative matrix team environment, have good organizational, communication [both oral and written], and interpersonal skills.
- Must be able to work independently.
Preferred Qualifications
- Working experience with DMPK
– bioanalysis, data management and statistical programming groups - Prior experience working with CROs
- Broad familiarity with the drug development process with 3 years of relevant experience in drug development.
- Advanced training in WinNonlin, R, SAS, NONMEM and/or Monolix