Head, Clinical Pharmacology

Cambridge, MA, United States
Dec 16, 2020
Required Education
Position Type
Full time
Our Mission: Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

Job Description:

The Head of Clinical Pharmacology will be responsible for developing, driving, and implementing global Clinical Pharmacology strategies for genomic editing therapies across multiple indications, by working with internal collaborators, consultants, external partners and regulatory agencies.

Reporting to the Chief Medical Officer, s/he will be a member of the program leadership teams providing Clinical Pharmacology perspectives and delivering modeling and analyses necessary to evaluate clinical options, enable plans, and optimize development programs. This includes study design, PKPD analysis and modeling, and program assessment. The successful candidate will bring extensive experience in clinical pharmacology and work cross-functionally with research and clinical teams to drive programs to success.

  • Develop and drive the Clinical Pharmacology strategies for genomic editing therapies across multiple indications
  • 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 science 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.

  • PhD or PharmD in Pharmacokinetics or Pharmaceutical Sciences, or related field required
  • A minimum of 10 years' 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
  • Strong 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 science colleagues to ensure relevant clinical pharmacology strategy is developed
  • Experience leading a team, 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

Leadership Skills:
  • Set and achieve goals
  • Inspire and mentor the team
  • Provide ongoing coaching and feedback
  • Decision making and problem solving

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.