Part-time Senior Legal Consultant

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 chronic diseases. In April 2019, Gelesis received FDA clearance for its lead product candidate, PLENITY. Gelesis anticipates PLENITY will be broadly available by prescription in the U.S. in 2020.

Additionally, Gelesis is developing its second 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 through a pipeline (GS300, GS400, GS500) in other GI inflammatory conditions where gut barrier and gut permeability potentially play a role, such as non-alcoholic steatohepatitis (NASH) and inflammatory bowel disease (IBD). Recent preclinical data presented this year support the potential role of this novel hydrogel platform technology in restoring gut barrier function and intestinal tissue health.

 

Part-time Senior Legal Consultant

The Senior Legal Consultant will oversee outside counsel and provide guidance on all legal and compliance initiatives, including advising on risk broadly throughout the company, as well as manage contracts and reviewing commercial transactions.

 

Responsibilities

  • Develop functional plans for managing legal matters, including activities to be performed in-house or through outside counsel to best manage company’s legal activities and manage risk for the business.
  • Manage and advice on corporate governance, business development transactions, legal compliance, general transaction support, license agreements, regulatory matters, risk management, and general contract management.
  • Draft, review, and negotiate a wide variety of agreements including confidentiality, material transfer, advisory board, market research, other intellectual property-related matters with domestic and international parties including clients, partners, vendors and users ranging from global life sciences organizations to healthcare organizations, research and clinical sites, landlords, subcontractors, and government agencies.
  • Provide leadership and technical guidance to ensure an effective ethics and compliance program. Oversees the development of programs to prevent and detect violations of laws, company policies and other misconduct, promote ethical practices and ensure the implementation of the compliance program throughout the organization.
  • Oversee negotiation and completion of agreements, confidentiality disclosures, material transfer, licensing agreements and other intellectual property matters.
  • Address developments in the corporate regulatory and governance environment and is proactive in areas related to compliance education and training. Monitors external developments in compliance, including laws and regulations, government investigations and industry best practices.
  • Provide oversight and leadership for all legal needs of the company across business functions.

Qualifications

  • JD from an accredited law school and admitted to practice in Massachusetts
  • A minimum of 10 years of experience practicing law including both law firm and in-house experience of a life sciences (pharma, biotech, device, diagnostic, et..)
  • Life Sciences experience spanning the research, development, approval, launch and commercialization of life science products a plus.
  • Broad legal experience covering multiple aspects of corporate law including business development, corporate contracting, intellectual property, employment and others within life sciences industry.
  • Experience with FDA and healthcare regulatory and compliance would be helpful.
  • Demonstrated experience in commercial legal analysis and planning including effectively managing multiple projects/priorities.
  • Proven ability to make sound judgements and decisions. Possess the ability quickly assess problems/situations and provide effective solutions.
  • Strong organizational and time management skills in order to balance working on multiple projects in parallel.

 

Gelesis is an EEO Employer

Send resumes to : careers@gelesis.com

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Senior Director; Clinical Operations

Job Description:

The Sr Director of Clinical Operations for Gelesis provides project leadership, under the direction of the Chief Medical Officer, in the design, initiation and execution of domestic and international clinical studies to support both product approvals and market adoption of company products.
The Sr Director of Clinical Operations will lead a team of internal directors and managers of Clinical Operations and manage external vendors is to ensure proper and timely completion of all clinical research projects. This position will lead a team that executes project plans, timelines, budget, vendors and while adhering to SOPs, regulatory and GCP standards.

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Contact us to learn more about career opportunities

careers@gelesis.com

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