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SR Clinical Trial Manager (CTM)

About Gelesis

Gelesis is developing a novel hydrogel platform technology to treat overweight and obesity and chronic diseases related to the GI pathway. Gelesis’ proprietary approach is designed to act mechanically in the GI pathway to potentially alter the course of certain chronic diseases. In April 2019, Gelesis received FDA clearance for its lead product candidate, Plenity™, as an aid for weight management in overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in conjunction with diet and exercise. Plenity is currently available in limited supply in the U.S. Additionally, Gelesis is developing its second investigational candidate, Gelesis200, a hydrogel optimized for weight loss and glycemic control in patients with type 2 diabetes and prediabetes. Novel hydrogel mechanotherapeutics based on the Gelesis platform technology are also being advanced in other GI inflammatory conditions, such as non-alcoholic steatohepatitis (NASH) and Chronic Idiopathic Constipation (CIC).

Gelesis was also named one of Fast Company’s Most Innovative Companies for 2020.

The Gelesis executive and advisory team includes some of the world’s leading experts in obesity, materials science, chronic disease research, and commercialization. Gelesis was co-founded by PureTech Health (LSE: PRTC). For more information, visit gelesis.com or connect with us on Twitter @GelesisInc.

Senior Clinical Trial Manager

Job Summary

Reporting directly to the Sr. Director of Clinical Operations, the Senior Clinical Trail Manager will participate in the planning and execution of clinical trials in support of clinical and commercial objectives set forth by Gelesis.

Responsibilities

  • Ensure clinical trials are executed in compliance with ICH/GCP (Good Clinical Practice) to ensure safety of all people and products are met
  • Partner with key stakeholders to design clinical and regulatory strategies with accountability for all clinical trials globally, working closely with the Head of Clinical Operations to ensure an integrated approach
  • Provide mentorship to junior team member as needed
  • Lead the process for developing study documents (e.g. protocols, informed consent, study diaries/questionnaires, etc.) Internal point of contact for all clinical study related issues
  • Provide vendor management and oversight to ensure studies are conducted according to the timeline, budget and quality measures set forth by the Study team
  • Coordinate team operations with internal and external collaborators to ensure operational excellence
  • Provide eTMF oversight
  • Manage the study budget, including review of clinical financial contracts and work orders; draft or review change orders as needed
  • Ensure completion of study deliverables and provide status update reports
  • Review and interpret study results for strategic decisions, publications and U.S. regulatory filings, contributing to the analysis, discussion and presentation of results.
  • Perform other duties as required and assigned by supervisor

Education and Training

  • Bachelors Degree in a life sciences or health related field required (an advanced life science degree is preferred)
  • A minimum of 5-8 years of sponsor-side experience managing clinical trials in a biotech or pharmaceutical setting.

Skills and Abilities

  • Strong critical thinking and problem solving skills
  • Excellent organizational, communication and presentation skills
  • Detailed oriented
  • A positive and collaborative personality
  • Willingness to embrace a dynamic, fast-paced work environment

 

Gelesis is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical​​​ condition, pregnancy, genetic information, gender, sexual orientation, veteran status, a person’s size or weight, or any other status protected under federal, state, or local law.

 

Please send resumes and expression of interest to:  careers@gelesis.com

Apply Now at careers@gelesis.com

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