Director, Clinical Pharmacology
Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
The Director of Clinical Pharmacology will be responsible for developing, driving, and implementing global Clinical Pharmacology strategies for genome editing therapies.
Reporting to the Head of Clinical Pharmacology, s/he will be a member of the program leadership team providing Clinical Pharmacology perspectives and delivering modeling and analyses necessary to evaluate clinical options, enable plans, and optimize development programs. This includes study design, PK/PD analysis and modeling, and program assessment. The successful candidate will bring experience in clinical pharmacology and work cross-functionally with research and clinical teams to drive programs to success.Responsibilities also include:
- Under the supervision of the Head of Clinical Pharmacology, develop and drive the Clinical Pharmacology strategies for genome editing therapies
- Develop and execute modeling and simulation plans; use model-based approaches to improve the efficiency of drug development and support dose selection and optimization
- Partner with DMPK and translational medicine to ensure relevant clinical pharmacology strategy is developed
- Ensure appropriate PKPD analyses including population PK, PKPD modeling and simulation, meta-analysis, and disease modeling to aid in dose selection, trial design, and/or clinical program decision-making
- Oversee clinical biomarker program and execute on program
- Oversee vendors, as appropriate, for population PK, PK/PD, and exposure-response analyses including document quality compatible with global regulatory submission requirements
- Contribute to program strategy, protocol preparation, study execution, data review/analysis, and clinical study reports; write and review clinical pharmacology summary documents.
- Support clinical team in preparation of regulatory documents
- Participate in discussions with FDA and other Regulatory Agencies to obtain feedback on clinical program PK/PD strategies.
- MD, PharmD or PhD in Biomedical / Chemical Engineering, Pharmacokinetics, Pharmaceutical Sciences, or related field required
- Experience in the biopharma industry in a Clinical Pharmacology role and proven ability to represent Clinical Pharmacology on project teams and with external partners
- Demonstrated experience in evaluating PK/PD analysis, PK modeling and simulation for clinical programs
- Knowledge of the role of clinical pharmacology in drug development, including the application of translational pharmacology as well as model-based approaches
- Experience partnering with DMPK and translational medicine colleagues to ensure relevant clinical pharmacology strategy is developed
- Experience working cross-functionally, and working with external partners
- Experience with regulatory interactions and submissions
- Understanding of genomic editing therapy preferred
- Ability to perform in fast-paced, dynamic, constantly evolving environment
- Excellent communication and organizational skills and attention to detail
- Strong time management skills; ability to prioritize multiple tasks efficiently
Meet your future team:
The Clinical Development team at Intellia is made up of one or more people in functions related to clinical research, including but not limited to biometrics, clinical operations, clinical pharmacology, medical science, medical writing, project leadership, project management, and regulatory affairs. This role will report directly to the V.P. and Head of Clinical Pharmacology. We are here because we believe genome editing has incredible potential to treat and cure life-threatening and fatal diseases, and we believe Intellia has the right people, strategy, and culture to do it well.
Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.
EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.