Senior Scientist DMPK, BD&PK (Pharmacokinetics)

Location
Cambridge, MA, United States
Posted
May 26, 2021
Ref
R97
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
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 want all of our 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 Can Achieve More At Intellia:

Intellia is seeking a highly skilled and motivated DMPK (drug metabolism and pharmacokinetics) senior scientist to join our team. The primary responsibilities for this position will be to design and oversee preclinical to development DMPK studies to understand pharmacokinetics of CRISPR/Cas9 based therapeutics. This position will work closely with Toxicology, Research, Clinical, Regulatory, Project Management and other departments. This position will develop DMPK strategies that meet regulatory requirements and project goals. This position will build and develop quantitative tools to translate PK/PD relationship from preclinical to clinical using modeling and simulation. Additionally, this position will contribute to regulatory filing submissions.
  • Design and oversee internal/external preclinical and development DMPK studies to understand pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of CRISPR/Cas9 based therapeutics
  • Represent DMPK as a subject matter expert to project teams ranging from preclinical to clinical
  • Responsible for the analysis, interpretation, integration, and reporting of DMPK data generated both internally and externally
  • Build and develop quantitative tools to translate PK/PD relationship from preclinical to clinical using modeling and simulation
  • Develop DMPK strategies that meet regulatory requirements and project goals
  • Author high quality Regulatory documents including INDs, CTAs and NDA filings. Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments
  • Participate in the management of CROs supporting DMPK studies


About You:
  • Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles is required.
  • Experience with CRISPR/Cas9, AAV, LNP, and ex vivo therapies is highly desirable
  • Required hands on experience on pharmacokinetic characterization using WinNonlin Phoenix.
  • Good to have in-depth hands-on modeling experience (e.g. , MATLAB/Simbiology, PK Sim, Simcyp, or, background using NONMEM to develop PK/PD models)
  • Experience leading regulatory enabling and early clinical DMPK
  • Industry experience at pharmaceutical/biotech companies or CROs, as higher desired.
  • Strong interpersonal and collaboration skills
  • Familiarity with regulatory submission including First-In-Human (FiH) Dosing plans
  • Understanding on GLP requirement, as highly desired.
  • PhD Degree in Pharmacy, Pharmacokinetics, Chemistry, Biochemistry, or related field with at least 2 years of relevant experience focusing on pharmacokinetics, pharmacology, or a related discipline including modeling and simulation experience-OR-
  • Master's or Bachelor's Degree in relevant discipline with at least 8 or 10 years' experience respectively maybe 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.