Head, Clinical Pharmacology

Location
Cambridge, MA, United States
Posted
Aug 27, 2020
Ref
556500281
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
At Intellia, we are revolutionizing medicine by harnessing the power of genome editing to develop potential cures. We bring new hope for people living with conditions including cancer, genetic disorders, viral infections, inflammatory disorders and many more.

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.

Responsibilities:
    • 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.


Requirements:
    • 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


What Intellia Stands For:

At Intellia, our mission is to develop potentially curative genome editing treatments that can positively transform the lives of people living with severe and life-threating diseases.

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us - trusting and counting on every single one of us.

- Explore because we seek new ways to tackle disease. Explore with unbounded minds...free from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

- Disrupt by thinking courageously...and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts...with that breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards...even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.

POSITION: Full-Time, Exempt

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.

Intellia's web-based application process is managed through Lever. Information submitted through application forms is collected by Lever and subject to Lever's privacy policy .