Eligo Bioscience mission is to develop treatments and cures for serious diseases in immuno-inflammation, oncology and infectious diseases.
Backed by top-tier investors from Silicon Valley and Europe, Eligo is an industry-leading biotechnology company, co-founded by scientists and professors from MIT and the Rockefeller University – now operating in Paris, France. We are progressing next-generation precision medicines through in vivo gene editing of the microbiome.
Our pioneering work in the field of synthetic biology has enabled Eligo to be elected as one of the 30 Most Innovative Companies by the World Economic Forum, to receive multiple prestigious international awards. We have also been featured in international media and scientific journals such as Nature Biotechnology, Science, The Economist, The BBC and The New York Times.
Eligonauts are driven, passionate, and motivated to impact the lives of patients by applying cutting-edge science to solve real unmet needs. We are at a very exciting point in time of the Eligo journey as we are embarking on the transition from a start-up deeply rooted in innovation to a clinical stage biotech with the objective to bring our lead program to the clinic within the next two years. We are therefore building a development team, in which the clinical development program lead will play a central role.
Eligo Bioscience has attracted highly-diverse top talent from all over the world, who are driven, passionate, and motivated to impact the lives of patients by applying cutting-edge science to save lives and treat chronic disease. Eligo embraces diversity, equal opportunity and inclusion and is committed to building diverse teams.
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 lead our most advanced program, EB005 in moderate-to-severe acne into the clinic and prepare the entry into clinical development of our other programs. We believe that our lead asset EB005 has the potential to drastically reduce the disease burden, and as a Clinical Development Program Lead you will 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 EB005 program from preclinical stage to clinical stage, in alignment with company strategy and in accordance with regulatory requirements.
RESPONSIBILITIES
- Acts as Clinical Development Leader of the EB005 program, ie, leads the overall program strategy from preclinical stage to first in man, supporting successful IND for a well-designed clinical proof-of-concept clinical study, while ensuring appropriate development of the target product profile and target value proposition
- Establishes clinical project plan and oversees program timelines, resources and budget.
- Leads the project team to meet program objectives and ensures operational plans are integrated across all functions.
- Acts as the development expert and leads the interactions with external stakeholders (e.g. regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups) as well as internal stakeholders.
- Secures and manages clinical operation support
- Understands and keeps updated with developments in the clinical and preclinical space relevant to the program, in close collaboration with Eligo research team
- Critically reads and evaluates relevant literature with deep understanding of the data and status of competitive products.
APPLICANT PROFILE
- Medical degree with >5 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 center or contract research organization.
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes and ICH guidelines
- Experience in early phase trials (Phase I-II) is strongly preferred.
- Previous experience or qualifications in microbiology, dermatology or immunology is a plus.
- Strategic thinker with good leadership and decision-making 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.
- Excellent problem-solving and conflict-resolution skills.
- Fluent in English and strong verbal & written communication skills are a must.