Clinical Development Program Manager

PARIS, FRANCE          FULL TIME

Eligo Bioscience is a seven-year-old biotechnology company, spun out of MIT and Rockefeller University, and based in Paris, France.

Eligo Bioscience has raised more than 20 million euros from leading investors in Silicon Valley and France to develop next-generation drugs that are based on the genetic engineering of bacteria and their viruses and aim to address unmet medical need in diseases associated with the microbiome.

The Company has been elected as one of the 30 Most Innovative Companies by the World Economic Forum in 2017, has received multiple international awards for pioneering work in the field of synthetic biology, and has been featured in international media and scientific journals such as Nature Biotechnology, Science, The Economist, The BBC and The New York Times.

Eligo Bioscience has attracted highly diverse top talent from all over the world, currently numbering over 40 Eligonauts from more than 10 countries, who are driven, passionate, and motivated to impact the lives of patients by applying cutting-edge science to save lives and treat chronic disease. Our pipeline is rapidly progressing towards the clinic and we are expanding our clinical development team and further building our clinical excellence. 

Eligo embraces diversity, equal opportunity and inclusion and is committed to building diverse teams. We strive to create an inclusive workplace that cultivates innovation through collaboration and empowers people to unleash their full potential.

— YOUR MISSION —

At Eligo Bioscience, we are passionate about developing new drugs to address unmet medical needs! We are looking for a high-performing and enthusiastic Clinical Development Program Manager  to partner with the Clinical Development Program Lead to progress our most advanced program into the clinic and prepare the entry into clinical development of our other programs. Our growing pipeline is in the area of infection, autoimmunity and cancer and we are seeking talented experts with affiliation with these disease areas. Our lead program aims to treat patients infected with Shiga toxin-producing E. coli, a life-threatening and debilitating infection which can escalate into Hemolytic Uremic Syndrome. We believe that our lead asset EB003 has the potential to drastically change the disease course and outcome, and as a Clinical Development Program Manager you will play a central role in bringing this therapeutic opportunity to patients.

POSITION SUMMARY

The Clinical Development Program Manager drives execution of the program, coordinates the program objectives and, in concert with the Clinical Development Program Lead, is accountable for achieving successful delivery of the EB003 program team activities at the program level, by meeting company and regulatory requirements with respect to time, quality, scope and budget.

— RESPONSIBILITIES —

  • Proactively manage the operational aspects of the EB003 program and team, including overall quality, documentation, coordination, program resources, timelines and budget.
  • Provide efficient updates to the Clinical Development Program Lead with respect to program plans, budget and timeline management, quality standards, risks and risk mitigation.
  • Ensure effective program plans are in place and work proactively with the program team to set priorities in accordance with program plans, SOPs, ICH/GCP guidelines and regulatory requirements.
  • Support the definition of quarterly program objectives with clear timelines, organize mid & end-quarter reviews and coordinate progress reports.
  • Make sure internal project management systems are up-to-date with most recent results, progress and timelines. 
  • Organize and chair Program Team meetings and ad hoc meetings with clear and relevant agendas and minutes, and coordinate all stakeholders.
  • Ensure good project communication and appropriate documentation throughout the project, with all key discussions and decisions clearly documented in accordance with SOPs and regulatory requirements.
  • Provide operational support during the start-up process of Eligo’s clinical studies, incl. but not limited to organization of kick-off meetings, set-up of trial master file, vendor selection, and clinical trial agreements and budgets.
  • Maintain background and context information on the program and onboard any new team members.

— APPLICANT PROFILE —

  • Ph.D. or Master’s degree in Life Sciences, Nursing Licensure or Pharmacy.
  • 5 or more yrs experience in the clinical phase of drug development as project manager. 
  • Experience in early phase trials (Phase I-II) is strongly preferred.
  • Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding drug development phases, clinical research and data management methods.
  • Experience or qualifications in microbiology, infection or immunology is a plus.
  • Demonstrated ability to form effective partnerships (i.e. with Program Lead).
  • Outstanding organization skills and demonstrated ability to deliver on time and within budget, with a sense of urgency.
  • Ability to drive delivery in others, facilitate team cohesion, collaboration and creativity.
  • Responsible work attitude, dedicated, trustworthy, strong ability to function under pressure, think independently and an active learner.
  • The person is meticulous and rigorous about his/her work, has scientific honesty and ethics. Works well with others in the team.
  • Fluent in English and strong verbal & written communication skills are a must.