Company Overview

At Synlogic: We are Putting LIFE Into Medicines
We are pioneers in the development of Synthetic BioticTM medicines, a novel class of LIVING medicines intended to transform the lives of patients with a broad range of diseases ranging from genetic and acquired metabolic diseases to inflammation and cancer.

Every day our teams work tirelessly to drive to deliver on 4 aspirations:

  • People: LIVING each day with passion for building up and building out our Synlogic team
  • Platform: Expanding and enhancing the technology to generate and protect novel LIVING medicines with new and versatile mechanisms of action
  • Products: Rapidly developing and commercializing Synthetic Biotics that transform the LIVES of patients and their families
  • Promise: Building our company to launch multiple novel LIVING medicines – mastering a new frontier in medicine

We combine Human Logic and Science Logic to drive meaningful work, careers, and LIFE at Synlogic. We foster a people-focused environment grounded in: Compassion, Transparency, Collaboration & Fun, while adopting a patient-focused mindset to inspire: Innovation, Integrity, High Performance, and LIFE Changing Results.

We continue to build and enhance our organization. If you want a settled environment, pursuing a well-walked path then this environment is probably not for you. If you want to join a growing company, work hard, and challenge yourself to find solutions at a new frontier of medicines then we would love to hear from you.

Job Description

Synlogic Therapeutics is seeking an energetic and motivated Senior Clinical Operations Scientist. They will report to Head/VP of Clinical Operations and will work hands-on with cross-functional teams in the design and execution of Phase I-IV clinical studies to ensure their timely completion with quality data. This individual will manage, plan, and execute clinical development programs and studies, including creating and managing study timelines, budgets, and study management plans. They will also ensure clinical operational and development deliverables and timelines are met across the development program(s). S/He must work effectively with all internal and external partners and is responsible for establishing and maintaining effective, positive and constructive CRO relationships to support all clinical development activities. The Senior Clinical Operation Scientist must effectively manage and motivate his/her direct reports.

Duties and Responsibilities

  • Responsible for in-house management of clinical studies and CRO/vendor management
  • Leads the evaluation, selection, and management of CROs. Owns relationship management with CRO and all vendors to ensure they are meeting Synlogic expectations of successful clinical trial implementationand execution, budgets and on-time delivery of quality data
  • Accountable for ensuring accurate and timely data cleaning/quality
  • Contribute to Protocol development and study implementation
  • Effective staff management
  • Responsible for infrastructure build for lead clinical trial programs, including inspection readiness.
  • Ability to build strong KOL and Principal Investigator relationships by understanding Synlogic’s science and data to support sound scientific conclusions.
  • Lead program development teams, and understand the intricacies among the different cross-functional groups.
  • Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials.
  • Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
  • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.
  • Attend scientific conferences as needed.

Job Requirements

  • Bachelor’s degree or equivalent in a scientific or healthcare discipline
  • 8+ years of clinical operations and study management experience in clinical operation and drug development, with at least
  • 3-5 years’ clinical monitoring experience, 2-3 years as a clinical manager and 3-5 years in a clinical operations leadership role in a CRO and/or Pharmaceutical or biotech company.
  • Demonstrated effective leadership of multiple cross-functional study teams
  • Experience in project planning, and identifying and managing clinical study risk
  • Experience in setting and managing clinical trial budgets, CROs and can develop/review site selection strategies, clinical supplies management, sample management, conduct and monitoring of clinical studies, etc.
  • Experience with hands-on monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required.
  • Experience in managing and partnering with CRO’s to deliver a broad range of CRO services
  • Working knowledge of regulatory and ICH GCP guidelines
  • Demonstrated strong interpersonal skills to ensure positive relationship with internal staff and external CRO partners
  • Proven experience in the oversight of the operational aspects of all stages of clinical studies
  • Demonstrated ability to work cross functionally with CMC, Regulatory, Research, etc.
  • Ability to organize and manage multiple priorities required
  • Strong oral and written communication skills with both internal and external stakeholders
  • Ability to work independently in a fast-paced environment with minimal supervision
  • Anticipated travel up to 10-20%

Other Requirements

  • Some travel is to be expected


We are at our best when we combine Human Logic and Science Logic to build great teams and deliver outstanding results. Our 6 values of Compassion, Fun, Trust & Respect, Innovation, Integrity and Results are central to our organization.
Our compassion for patients is the engine that drives our innovation and motivates our sense of urgency; always remembering that patients are waiting. Our compassion for each other creates a safe environment for continuous risk taking and personal development. We connect with our colleagues by having fun together. We take our work seriously and value integrity in producing the highest quality work. We trust each other, respecting all ideas and driving accountability to generate the best results for our patients and team. We encourage openness, direct feedback and transparency in decision-making to enable trust and maintain the nimbleness of the group.


To apply for this position please send your resume to:

Synlogic, Inc. is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.