Remote Executive Medical Director - Clinical Development CAR-T Programs

Location United States
Discipline: Medical & Pharmacovigilance
Job type: Permanent
Salary: £Excellent salary, bonus, benefits and lucrative stock scheme
Contact name: Stuart Gilboy

Contact email: stuart.gilboy@rbwconsulting.com
Contact phone: 16179821238
Job ref: 21085
Published: 29 days ago
Expiry date: 12 April 2021

Location: Remote role (Cambridge, MA)

Remote Executive Medical Director, CAR-T


A multi-disciplinary team of world-class researchers and drug developers works every day to translate technology into breakthrough human therapeutics. Our lead program targeting the blood diseases β-thalassemia and sickle cell disease has entered clinical testing, and our immuno-oncology programs, focused on gene-edited allogeneic CAR-T cell therapies, have the potential to deliver a new generation of cancer therapies to patients.


Job Summary
They seek an enthusiastic Executive Medical Director with a high degree of scientific acumen to help develop allogeneic CAR-T programs in clinic and who are excited by the unique opportunity of bringing cutting-edge therapies to market.


In this role, the incumbent will report to the VP of Clinical Development and help develop allogeneic CAR-T programs created for the treatment of various malignant hematologic indications. The successful candidate will work across different functional teams, support 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.


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 medical 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

  • Travel, as needed, nationally and internationally

Minimum Qualifications:

  • A medical degree (MD), and 3-5 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)


For more information on this remarkable and cutting-edge biotech please CLICK APPLY and forward an up-to-date resume or reach out to stuart.gilboy@rbwconsulting.com

Excellent salary, bonus, benefits and lucrative stock scheme