Translational Pharmacologist, Director/Senior/Executive Director

CRISPR Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Life Sciences R&D/Engineering
  • Post Date: 02/15/2021
  • Website: crisprtx.com
  • Company Address: 610 Main Street, Cambridge, MA, 02139

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene-editing company focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.

Job Description

CRISPR Therapeutics is seeking a motivated individual to lead a group focused on translational drug development efforts. The successful candidate will be responsible for strategic planning and execution of Translational Pharmacology efforts related to the development of investigational, CRISPR gene-edited cell therapies. This position reports into the head of Translational Pharmacology. In addition to managing a group, the candidate will be a core member of the drug development team and responsible for the strategic development, documentation, and oversight of the drug candidate translational pharmacology plan. Such plans will explore the key biology to be examined during clinical trials and the PK/PD data necessary for registering CRISPR Therapeutics therapies.  Furthermore, this role will require significant engagement in authoring regulatory filing documents and participating in meetings with Health Authorities.  Strategic planning and execution will be accomplished in collaboration with others as detailed subsequently.

This is a leadership opportunity and includes managerial responsibilities.  The successful candidate will thrive in a fast-paced, matrixed and highly collaborative environment.  The ability to work in a new field and with an element of uncertainty is important.

 

Responsibilities

  • Demonstrate a thorough understanding of the biology of CRISPR Therapeutics’ therapies
  • Designing translational pharmacology strategies for CRISPR candidate therapeutics
  • Translate biological understanding and clinical research questions into research approaches within clinical trials
  • Collaborate with discovery/pre-clinical scientists, bioanalytical scientists, and clinical scientist/medical director for development of the translational pharmacology plan
  • Propose PK/PD endpoints appropriate for programmatic advancement decisions, ensure proper sampling in clinical protocol, and work with Assay Team to identify and develop appropriate assays
  • Collaborate with clinical assay colleagues and sample operations to define sample journey and develop appropriate clinical laboratory manuals
  • Collaborate with exploratory research focused colleagues for bespoke laboratory investigations
  • Responsible for overall execution of PK/PD plans leveraging clinical trial samples
  • Analyze and interpret PK/PD data, including in the context of other clinical trial data (efficacy, safety and biomarkers), collaborating with program development colleagues
  • Ensure that clinical pharmacology studies and assay sample analyses are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, CHMP, WHO, GLP, and ISO). 
  • Proactive creation of standards in this new field of gene-editing based therapies
  • Ensure quality and timely submission of all clinical pharmacology-related documents and materials for regulatory filings and interactions
  • Manage a team of ~3-5 direct reports

Minimum Qualifications

  • MD, PhD or PharmD and post-doctoral training in a field related to Translational Pharmacology, Clinical Pharmacology, or related Biological field
  • At least 5 years of experience in translational development-related roles in a biotech or pharmaceutical setting
  • Understanding of pre-clinical, translational, and clinical drug development
  • The ability and fortitude to work proactively and independently in a fast-paced highly collaborative setting
  • Managerial experience

Preferred Qualifications

  • 7+ years of experience in a translational development-related position(s) in a biotech or pharmaceutical setting
  • Experience with development of Cell and Gene Therapy or ATMP products, and development requirements
  • Experience in developing immuno-oncology therapies, including CAR T cell therapies
  • Experience managing a translational sciences team

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.