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Sr. Manager/Associate Director, Clinical Science & Biomarker Development

Cambridge, MA · Science/Research
Company Overview
Synlogic’s initial pipeline includes Synthetic Biotic medicines for the treatment of rare genetic diseases, such as Urea Cycle Disorder (UCD) and Phenylketonuria (PKU). In addition, the company is leveraging the broad potential of its platform to create Synthetic Biotic medicines for the treatment of other diseases, such as liver disease, inflammatory and immune disorders, and cancer. Synlogic is collaborating with AbbVie to develop Synthetic Biotic-based treatments for inflammatory bowel disease (IBD).

Every day we work tirelessly 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 continue to build and enhance our organization. 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.
 
Behaviors

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 are at our best when we blend Human Logic and Science Logic to build great teams and promote a great culture.

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.

Key Responsibilities

Responsible for a broad scope of varying activities to support department and corporate goals. Primary responsibilities for this position are to:
  • Coordinate and implement novel assays for projects across Synlogic’s growing portfolio
  • Manage the outsourcing and validation of clinical assays (e.g., pharmacodynamic, predictive, prognostic, and safety biomarkers)
  • Review and negotiate contracts with vendors and collaborators and execute contracted work within budget and on schedule
  • Assemble, evaluate, and present scientific and medical data
  • Support global regulatory strategy and contribute to the generation of investigator brochures, IND applications, clinical protocols, and other clinical and regulatory documents as appropriate
  • Provide functional area expertise to discovery and development project teams
  • Assist with writing manuscripts (paper, abstracts, posters, etc.), and review and summarize relevant literature
  • Collaborate with the Clinical team on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting
  • Provide scientific input to preclinical pharmacology teams for translational studies of interest, including biomarker development strategies
  • Participate in the identification of appropriate external investigators and consultants
  • Develop and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors
  • Provide support to advisory boards, consultant meetings, and investigator meetings, including preparation and delivery of presentations
  • Manage activities of vendors, investigators, and research collaborators to ensure compliance with the study procedures and overall clinical objectives
  • Ensure that study documentation is maintained according to applicable regulations, industry-accepted standards and SOPs that govern clinical studies both in the field and in-house
Qualifications
  • Minimum of 7 years of industry experience
  • Experience in rare diseases, metabolic disorders, and/or oncology is highly desirable
  • Must have an MS degree or equivalent in a health science field.
  • Strong scientific background, with clinical and/or research experience
  • Strong oral and written communication skills as well as excellent organization and presentation experience
  • Highly adaptable, proactive, deadline- and detail-oriented, and will maintain a high level of professional expertise through recent industry training and familiarity with clinical research publications
  • Work independently under general direction in a fast-paced environment
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