Clinical Trial Manager
Gelesis is a clinical stage medical device company developing a new category of therapy to safely treat overweight, obese and diabetic patients. Obesity is the world’s largest health challenge affecting a greater number of people than any other disease on the planet. The sequela from obesity includes diabetes and cardiovascular events, which can ultimately lead to death. Gelesis100, our lead product, is a first-of-its kind smart pill which is designed to act mechanically in the stomach and small intestine to increase satiety and decrease hunger, resulting in reduced caloric intake and weight loss. Gelesis100 is administered orally as a capsulated device.
Gelesis is looking for an experienced clinical operations leader to join our team at our HQ in Boston, Massachusetts. The selected individual will participate in the planning and execution of clinical trials for Gelesis100 and all other future products to support regulatory approvals and claims development. He/she will provide hands-on support in planning and executing clinical trials and working with external vendors and CROs in various Gelesis programs. He/she will take responsibility in ensuring the execution of Gelesis clinical trials.
- Ensure goals and objectives for all clinical development programs are met.
- Develop or leads the process of developing study documents for all clinical development programs (e.g., protocols, Investigator’s Brochures, Monitoring Plans, Informed Consent Forms, study diaries/questionnaires, etc.).
- Negotiates vendor contracts, statement of work (SOW), and budgets; establish change order, as needed.
- Establish and maintain relationships with vendors and site representatives.
- Work closely with vendors to oversee and effectively manage recruitment strategy/issues.
- Work closely with Quality Assurance to ensure Clinical Quality and Regulatory Compliance as per ICH cGCP.
- Provide input to relevant SOP’s and standard clinical operations.
- Provide strategic and tactical input into clinical development timelines; develop study specific goals, tracks metrics, and produce executive summary reports.
- uate site and vendor performance against agreed upon budget, SOW, and timelines for clinical development programs.
- Minimum education: B.S. in a scientific or health-care related discipline
- Minimum experience: 5 years leading or managing global clinical studies for a medical device, pharmaceutical and/or biotechnology company
- Experience in global clinical trials (Experience managing global clinical trials is required)
- Experienced individual with proven ability to interact, train, and build strong relationships with vendors and clinical monitors
- Familiar and comfortable with clinical operational concepts, practices, as well as FDA and international regulations
- Possess strong critical thinking and problem solving skills
- Detail oriented
- Excellent leadership, communication, and organizational skills
- Ability to manage and lead cross functional teams, internal and external
- Prior experience in the obesity and/or diabetes drugs or devices is preferred, but not required
- 10-15% domestic and international travel to clinical trial sites, investigator meetings, regulatory bodies, etc. may be required
- Self-starter is a must
- Flexible to changing priorities
- Strong and positive work ethic
Equal Opportunity Employer
Gelesis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Gelesis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.Apply Now