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Clinical Program Director (MD)

Department: Medical
Location: Cambridge, MA

Clinical Program Director (MD)

  

Position Summary:

For the successful candidate, this opportunity offers early entry into a growing and successful biotechnology company, with an ability to impact the company’s culture, build value for patients and shareholders, and pioneer an emerging field.

Responsibilities:

  • Provide scientific/clinical expertise in design, medical monitoring, and interpretation of Phase 1/2 studies involving new indications for Ecobiotic® microbiome drugs. 

  • Lead the development of the Integrated Study Plans (project plans, protocol outline/study design documents, protocols, CRFs, operational and analytic plans) and study summaries, IND submissions, and technical reports;

  • Interact with R&D teams in the conception and realization of next generation product candidates and the translation of these Ecobiotic drugs into POC studies.

  • Preparation of manuscripts in consultation with external experts; Responsible for the scientific content of status reports for upper management and clinical/project team use.

  • The individual would apply an in-depth understanding of the disease from a basic science perspective to translate into the clinic in initial first-in-man and proof-of-concept studies. 

 

Basic Qualifications:

  • MD from a recognized school of medicine, preferably with demonstrated expertise (board certification) in Metabolic Disorders, Endocrinology or Infectious Disease preferred.

  • Research background in basic research aspects in gastroenterology/immunology is desirable to help in the design and implementation of clinical studies.

  • At least 2 years experience in clinical research in the pharmaceutical industry or academic clinical research is preferred.

  • Proven leadership skills with ability to innovate and collaborate with a small team to articulate clear scientific strategy.

  • The candidate should have strong communication and presentation skills and a record of achievement in scientific investigation. 

  • Ability to work in a matrix environment with cross-functional teams including a variety of scientific disciplines, bioprocess and manufacturing is required.

Up to 20% annual travel (domestic and international) is required.

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