Clinical Development Program Lead

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 Lead  to partner with the Clinical Development Program Manager to lead 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 Lead you would play a central role in bringing this therapeutic opportunity to patients.

POSITION SUMMARY

The Clinical Development Program Lead provides strategic clinical guidance and leads the development of the EB003 Lead program from entry into the clinic, continuing through clinical Proof-of-Concept. In concert with the Clinical Development Program Manager, the Program Lead is accountable for the development of EB003, in alignment with company strategy and in accordance with regulatory requirements.

— RESPONSIBILITIES —

  • Acts as Clinical Development Leader of the EB003 program – leads the overall program strategy, development of the target product profile and target value proposition.
  • Establishes program plan and oversees development planning, execution and budget.
  • Leads the integrated development team to meet program objectives and ensures operational plans are integrated across all functions.
  • Takes a leadership role in and acts as the clinical expert in the development and management of interactions with external stakeholders (e.g. regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups) as well as internal stakeholders.
  • Understands policies and procedures set forth by health authorities and provides strategic oversight to ensure appropriate evidence is generated to support decision making.
  • Sets standards for clinical and operational excellence, including process improvement, SOP development and ensures implementation.
  • Understands and keeps updated with developments in the clinical and preclinical space relevant to the program.
  • Critically reads and evaluates relevant literature with deep understanding of the data and status of competitive products.

— APPLICANT PROFILE —

  • Medical degree with >3 years, or PhD with >7 years of technical, operational and managerial experience in planning, executing, reporting and design of clinical trial studies in a pharmaceutical company, academic centre or contract research organization.
  • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes and ICH guidelines regarding drug development phases, data management methods, and global clinical development.
  • Experience in early phase trials (Phase I-II) is strongly preferred.
  • Previous experience or qualifications in microbiology, infection or immunology is a plus.
  • Strategic thinker with good leadership and decision-making skills.
  • Patient-oriented, with good knowledge of drug development activities.
  • Performance-oriented with ability to work along agreed timelines and with high-quality execution.
  • Excellent problem-solving and conflict-resolution skills.
  • Ability to lead 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.