Medical Director

Generation Bio

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Research Sci/Assoc/Mgr
  • Post Date: 01/13/2021
  • Website: generationbio.com
  • Company Address: 215 First Street, Cambridge, Cambridge, MA, MA 02142

About Generation Bio

Generation Bio is creating a revolutionary new class of genetic medicines that deliver durable, high levels of gene expression and have drug-like properties, including ability to titrate to effect and re-dose. Our unique GeneWave technology allows us to overcome the limitations of other approaches by delivering larger genes, including more sophisticated regulatory elements, and avoiding the immunogenicity which limits both the number of patients who can be treated and the ability to re-dose them over time.

Job Description

Generation Bio is a biotechnology company leading a new generation of gene therapy. With our proprietary re-dosable ceDNA technology, we are expanding the reach of gene therapy At Generation Bio, our goal is to bring the life-saving benefits of gene therapy to more people, living with a broader range of diseases, in more places around the world. Our vision is to make the ravages of genetic disease as imaginary to the next generation as polio feels to children today.

We are a thriving, collaborative, creative community of diverse talents, beliefs, and experiences relentlessly dedicated to our mission. Founded and launched by Atlas Venture. Headquartered in Cambridge, Massachusetts. Committed to a future where more people can live full lives.

Delve further. Please visit www.generationbio.com or follow @generationbio.

 

Position Summary

 

We seek an enthusiastic Medical Director with a high degree of scientific acumen to help develop clinical plans for Generation Bio’s Hemophilia A program and is excited by the unique opportunity to bring leading-edge gene therapies to market. The candidate should be a team player, have deep knowledge of clinical trials and GMP guidelines, detail oriented with prior clinical research experience in industry.

 

In this role, the Medical Director will work across different functional teams to support the design and execution of our First in Human clinical trials, the drafting of medical/ scientific documents, regulatory submissions, site determination and start-up, KOL advisory boards, trial execution and safety monitoring, and data analyses. In this high visibility position, the candidate will be interfacing with both internal and external stakeholders including KOLs and Principal Investigators.

 

The successful candidate will participate in the strategic development and tactical implementation of the early clinical studies for our lead non-viral gene therapy programs. This will include providing direct medical/physician oversight for phase 1/pivotal trials and proof of concept clinical trials, and clinician input into all aspects of discovery and preclinical development, from target selection to preclinical and regulatory strategy and tactics. The ideal candidate will have an understanding of hepatology and/or gene therapy, genetics, rare diseases, pediatrics, early phase clinical development, the principles of pharmacology, nonclinical (toxicology) and regulatory requirements for testing new therapies in humans along with experience working closely with clinical operations.

Responsibilities

  • Understand (and eventually develop into local expert for the underlying scientific principles of the disease indications and pipeline gene therapies being studied
  • Provide clinical and scientific input into Discovery Research and Early Development activities, including disease education, target identification, lead selection, preclinical pharmacology POC, nonclinical toxicology, biomarker strategy, and IND enabling studies to develop optimal translational medicine approaches to facilitate development to clinical POC
  • Contribute to the development of robust product development plans for each program, including providing content for clinical development and other sections, as needed
  • 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
  • Develop protocols and oversee clinical trials as a medical monitor
  • Collaborate with clinical operations and medical affairs to ensure clinical development program success
  • Contribute to the development of regulatory strategy and act as the medical expert in meetings with regulatory authorities
  • Ensure and support effective leadership, management and governance, and seamless collaboration across all areas of Research and Development
  • Serve as the Sponsor’s medical representative to external collaborators
  • Travel, as needed, nationally and internationally

Minimum Qualifications:

  • A medical degree (MD), and 3 years’ Pharmaceutical/Biotech industry experience, including time managing clinical trials
  • Past experience in hematology or stem cell transplant clinical trials is preferred, but not required
  • Strong scientific background with experience in reviewing & interpreting scientific and study data is required
  • Medical monitor experience in clinical development, or clinical translational medicine related areas
  • Track record of scientific publications strongly preferred
  • Working knowledge of biostatistics, data management, clinical operations and scientific and technical processes desirable
  • Working knowledge of applicable US and EU regulatory requirements and of the drug development process
  • 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 challenging and fast growing 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)
  • Ability to work in a team-oriented environment
  • Scientifically rigorous, highly organized, and with significant attention to detail

POSITION: Full-Time, Exempt

 

EEOC Statement: Generation Bio 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, gender, religion, national origin, gender identity, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with 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.