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

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Director; Regulatory Affairs

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 mechano-therapeutics 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.

Director of Regulatory Affairs

Job Summary

Reporting directly to the Sr. Director/ Head of Regulatory & Quality, the Director of Regulatory Affairs will develop global regulatory strategies for the Gelesis products, execute regulatory plans to support the Gelesis business goals, and promote regulatory compliance throughout the organization and throughout the lifecycle of our products. Working in cross-functional teams this position will ensure that labeling and promotional material complies with applicable laws and regulations.  Key responsibilities of this function include but are not limited to:

Responsibilities

Regulatory:

  • Develop domestic and global regulatory strategies and plans which support company goals
  • Author regulatory filings in cooperation with Operations, Development, and Clinical teams to obtain timely market authorizations.
  • Directly communicate and collaborate with regulatory authorities (FDA, Health Canada, Notified Body and others)
  • Manage programs for device and establishment registrations and UDI/GUDID compliance
  • Perform regulatory impact assessments of process and product changes to determine reportability. Prepare documentation for no-filing decisions.
  • Define regulatory policies and processes in written procedures. Promote and monitor compliance to these processes.
  • Represent Regulatory Affairs in cross functional product development teams, identify regulatory requirements, and participate in design reviews.
  • Participate and support compliance related activities, including internal Quality System Audits and inspections by regulatory authorities.
  • Manage initiatives to maintain or obtain compliance to new or emerging regulations, such as EU MDR, MDSAP.
  • Maintain corporate regulatory files.

Marketing/Medical Affairs

  • Represent Regulatory Affairs in cross-functional teams for the review and approval of promotional material and labeling.
  • Represent RA on cross functional teams for review and approval of training and non-promotional customer facing material.
  • Promote awareness of evolving regulations and guidance documents relating to promotional materials and labeling, including advisory and enforcement letters.
  • Manage/prepare pre-clearance and regulatory submissions relating to labeling and promotional material to regulatory authorities.

Education and Training

  • A Bachelor’s Degree in a science field required; PhD or PharmD preferred
  • A minimum of 10 years of experience in Medical Device Regulatory Affairs environment, including proven experience with:
  • The review of advertising/promotional materials for medical devices.
  • regulatory submissions (510k, de novo, class III design dossiers)
  • European and international regulations (MDD, MDR, CMDR, MDSAP)
  • Proven experience presenting to the FDA and foreign regulatory bodies
  • Detailed knowledge of FDA regulations and guidance documents pertaining to labeling and advertising/promotional materials.
  • Working knowledge of international standards for risk management, design controls, biocompatibility, usability engineering etc.
  • Understanding of hydrogel technologies would be very advantageous (but not required)

Skills and Abilities

  • Strong critical thinking and problem-solving skills.
  • Data driven, ethical decision-making skills.
  • Excellent communication and presentation skills
  • Excellent time management and organizational skills
  • Flexible and adaptable to changing project priorities, work assignments and deadlines.
  • Detailed oriented
  • Experience in working in a fast paced, high-volume & cross functional environment handling multiple tasks
  • Reliable, conscientious and discreet
  • Proven ability to prioritize and multitask
  • Self-motivated, shows initiative, is proactive and able to work independently as well as in a team.
  • Strong computer skills including knowledge of Excel, Word, and PowerPoint
  • Flexible to take on other duties as assigned

 

 

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

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Digital Analytics Manager

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.

Who we’re looking for:

Are you excited by the prospect of using analytics to drive business growth? Do you possess exceptional business curiosity and smarts, and are passionate about data? Do you want to work in a challenging but fun environment, in an entrepreneurial but well-resourced and supportive environment? Are you intrigued by the idea of bringing an FDA-cleared, prescription-only product into a full-scale direct-to-consumer (DTC) ecommerce market – and helping to lead the way?

We are looking for a smart and passionate individual to join the Gelesis Consumer Marketing team. In this role, you will build and lead Gelesis’ internal marketing analytics function. You will drive the important analytical insight into marketing recommendations and actions.

In this role you will drive data collection, and provide analysis and actionable insights to the marketing and leadership team. You will be aligning marketing objectives with established measurement methodologies, tactic-level marketing execution, rigorous analysis, data visualization, and the technology ecosystem required to support these activities will ensure the team succeeds.

You will lead the analysis of all customer acquisition marketing channels, spanning digital and offline. In addition, you will own the analytics tech stack, and oversee the implementation and operation of an omnichannel marketing attribution model. If this excites you, read on!

What you will do:

  • Monitor, understand and share updates on new and ongoing digital initiatives, including website traffic and engagement, as well as paid and organic digital campaigns.
  • Interpret marketing campaign and product sales statistics into deliverables and recommendations to deliver ecommerce conversion optimization and ROI improvements.
  • Translate performance data into clear, actionable insights that help Gelesis stakeholders understand prospect needs, behavioral drivers and content performance in a concise and effective manner.
  • Recommend and oversee implementation of new performance- and engagement-focused features and optimizations of our flagship website, MyPlenity.com.
  • Lead the conceptualization, design, launch and reporting of website A/B and multivariate testing.
  • Share research-driven insights on industry trends and best practices (digital marketing, SEO, omnichannel attribution, etc.) across the marketing team.

The ideal candidate will:

  • Be the definition of a “business thought partner,” who truly enjoys finding ways to improve the business – with data analytics as the main tool of discovery.
  • Possess a strong self-guided work ethic supported by excellent organizational and time-management skills, demonstrating the ability to work independently with competing priorities and a high level of detail.
  • Be a dynamic team-player with an entrepreneurial spirit who embraces a growing, start-up environment while “thinking big,” beyond the day-to-day.
  • Show strong ability from strategy through execution, being able to conceptualize, build out, and present new ideas, then building support for them and driving through execution.
  • Be a strong fit with the following characteristics:
    • Passionate: about the role and power of analytics to yield insight and opportunities.
    • Innovative: experience challenging the status quo and finding novel solutions to problems.
    • Results-oriented: able to focus on what is truly important, manage tight timelines, and deliver results.
    • Intellectually curious: restless in looking beyond trend- and summary-level data to understand (and improve) business performance.
    • Self-starter: able to both identify problems and propose solutions to them as well as take direction and communicate efficiently with a small, fast-paced team

 

Required qualifications & experience:

  • Have extensive experience in a digital marketing team for a consumer-focused retail/ecommerce business. Examples include web analytics, SEO, SEM, social, email nurture, website optimization, e-commerce, and A/B testing. Familiarity with platform analytics tools is a requirement.
  • Bachelor’s degree in a relevant quantitative field such as business/data analytics, statistics, mathematics. Alternatively, Bachelor’s degree in Business Administration with an emphasis in quantitative discipline or Marketing.
  • Expertise in Google Analytics, Data Studio and Tableau (in addition to advanced MS Excel)
  • Experience in Marketing Cloud (or similar email platform) for creating/ adding list segmentation, tracking, and reporting on email marketing performance.
  • In-depth understanding of digital marketing campaign strategies and SEO practices.
  • Experience with data mining in a data analyst role creating reports, metrics development, database querying, preferably within a marketing or e-commerce setting.
  • Ability to synthesize and summarize complex analytical issues, highlighting implications for the business.
  • Storytelling with data via dashboards and data visualizations in Tableau or Google Data Studio.
  • Excellent written and oral communication skills.

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

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Manager: Medical Communications/Medical Information, Medical Affairs

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.

Position

The Medical Affairs Manager; Medical Communications/ Scientific Communications will be a key member of the Gelesis Medical Team. The candidate will have strong knowledge of the Medical Affairs function, particularly medical information, medical communication, promotional review committee, congress and publication planning. Responsible for analyzing, tracking, and continuous improvement of medical affairs processes, systems, procedures, and SOPs. Works with doctors, scientists, and other subject matter experts, to create documents that effectively and clearly describe research results, product use, and other medical information.  Ensures the documents comply with regulatory, journal, or other guidelines in terms of content, format and structure. Responds to inquiries from HCP’s, including unsolicited requests for off-label information.

Gelesis currently has a product with an indication for weight management in overweight and obese patients, in addition to pursing opportunities within GI, and NASH/NAFLD. Experts in product development in these therapeutic areas, as well as candidates with broad therapeutic area experience and/or complementary and relevant scientific expertise are of interest. The role will report into the VP of Medical Affairs.

This position will be based in Boston, MA. The position is expected to work remotely during the pandemic. However, the candidate may be expected to report to the office in the future as determined by management.  Up to 10% travel.

Key Responsibilities

  • Development of required medical information, surveillance requirements, publication planning, medical education, and congress planning
  • Working with cross-functional teams for each congress to align on strategy and tactics for congress presence and activity
  • Facilitate the creation of content for Medical Affairs at congresses throughout the year, working cross-functionally with vendors, public relations and marketing
  • Create and maintain metrics on key business processes to monitor Medical Information and Medical Communication services and related medical affairs needs
  • Participation on Medical Review Committee
  • Assist in development of policies and procedures
  • Engagement with Key Opinion Leaders (KOLs)
  • Preparation of Standardized Response Letters (SRLs), FAQs, and custom replies to specific requests
  • Provides guidance on and reviews promotional and sales training documents, ensuring accuracy and appropriateness from medical affairs perspective
  • Ensure high quality medical content and accuracy across all functions
  • Project management and organization of the day to day medical affairs operations
  • Manage relationships with vendors, stakeholders, and/or customers, providing training and responding to inquiries.
Job Requirements

Qualifications

  • Experience in medical affairs, medical information and/or clinical development in an industry setting (medical device preferred)
  • A bachelor’s degree (BA or BS) in a related scientific discipline required with 5+ years’ industry experience or advanced degree (e.g., PharmD, PhD) in related field with >2 years’ industry experience required
  • Minimum experience of 1-3 yeas in Medical Information/Communications in the pharmaceutical and/or medical device industry
  • Strong ability in clinical/medical writing and verbal communication
  • Detail oriented, highly organized, and ability to work independently
  • Prior experience in weight management, nutrition or GI product development preferred
  • Flexibility to work within fast pace and changing environment
  • Personal characteristics of integrity, team work, can-do-attitude and personal excellence

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

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Contact us to learn more about career opportunities

careers@gelesis.com

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