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Senior Director, Clinical Development
Full Time | Contract Research 8 Months Ago
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CRISPR Therapeutics is Hiring a Senior Director, Clinical Development Near Boston, MA

Company Overview

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.

Job Summary

We seek a Senior Director, Clinical Development with a high degree of scientific acumen to help develop CRISPR Therapeutics’ allogeneic CAR-T programs in clinic and who is excited by the unique opportunity of bringing cutting-edge therapies to market.

In this role, the incumbent will report to the Executive Director, Clinical Development and help develop CRISPR’s allogeneic CAR-T programs created for the treatment of various hematologic/oncologic indications. The successful candidate will work across different functional teams, support the clinical development function and be responsible for tactical implementation of the early clinical studies for our lead programs. This will include providing direct medical oversight for proof of concept and pivotal clinical trials, and clinician input into all aspects of discovery and preclinical development, from target selection to preclinical and regulatory strategy and tactics. In this high visibility position, the candidate will be interfacing with both internal and external stakeholders including KOLs and Principal Investigators. In addition, the senior director will be expected to actively support strategic discussions for the program on development, regulatory, and clinical topics.

Responsibilities

  • Contribute to the development of robust clinical plans for the IO program
  • Develop protocols and oversee clinical trials as a medical monitor
  • Understand (and eventually develop into an expert) the underlying scientific principles of the disease indications and allogeneic CAR T cells being studied
  • Collaborate with clinical development partners and across functions to ensure program success 
  • Contribute to the development of regulatory strategy and act as the clinical expert in meetings with regulatory authorities
  • Identify and establish relationships with leading KOLs and principal investigators, including organizing and running KOL meetings, as needed
  • Organize and present at relevant clinical advisory boards and medical/scientific meetings
  • Serve as the Sponsor’s medical representative to external collaborators
  • Actively support, and potentially lead, strategic discussions around clinical development and regulatory interactions.
  • Travel, as needed, nationally and internationally

Minimum Qualifications

  • A medical degree (MD), 5 years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or a minimum of 5 years in a related, research/academic environment. Background in oncology is required. Experience with hematology, stem cell transplantation, or cell therapies is preferred, but not required.
  • Strong scientific background with experience in reviewing and interpreting scientific and study data is required
  • Medical monitor experience in clinical development, or clinical translational medicine related areas
  • Working knowledge of biostatistics, data management, clinical operations and scientific and technical processes desirable
  • Experience in building and maintaining effective relationships with external KOLs, advisory boards and other key external therapeutic area influencers desirable
  • Team player who works collaboratively in a team matrix environment
  • Ability to work independently to resolve challenges and conflicts
  • Excellent written and oral communication skills
  • Integrity, honesty and highest ethical standards and a sense of personal accountability
  • Quickly adapt and provide innovative solutions to challenges as they present themselves
  • Ability to travel on average 20% of the time (range 0-30% each month)

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.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

Job Summary

JOB TYPE

Full Time

INDUSTRY

Contract Research

POST DATE

07/17/2022

EXPIRATION DATE

10/14/2022

WEBSITE

crisprtx.com

HEADQUARTERS

Cambridge, MA

SIZE

200 - 500

INDUSTRY

Contract Research

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