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Senior Director; Clinical Operations
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.
- Develop and propose standards, processes and systems to optimize all aspects of clinical trial operations in compliance with global regulatory standards and in collaboration with other key functional areas, external vendors and advisors, including study feasibility; CRO selection and contracting; site initiation and oversight; patient recruitment strategies and plans; trial project plans integrating CRO team and practices with internal team; tracking and monitoring of trial progress against plans
- Build, lead and mentor clinical team to support the scale and scope of our clinical development programs.
- Support the CMO in developing a clinical research strategy and workplan with required resources necessary to execute this plan, including scenario planning, high-level forecasting of timelines, assesses program level feasibility, estimation and allocation of resources and budget, and development of high-level operational strategies
- Interface with external stakeholders (KOLs, partners, advocacy groups)
- Develop timelines and budgets to support the clinical research plan
- Lead the identification, evaluation, and selection of vendors as needed to support clinical trials.
- Provide leadership of clinical trials execution from protocol design to the final study report,
- Directly manage at least one clinical study per year
- Ensure medical writing processes are in place for creation of good quality clinical documents. Contribute to authoring clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND submission documents, responses to Health Authorities’ questions.
- Provide leadership and supervision with respect to CRO outsourcing: RFPs, CRO selection, and day to day study management activities of CROs.
- Provide routine updates to senior management regarding the status of ongoing studies
- Ensure that there is appropriate and accurate processing and tracking of Investigator and/or vendor payments
- Proactively identify and resolve issues and manage escalation as appropriate
- Develop contingency/risk management plans for projects and support CMO in creating effective risk management plans.
- Work closely with Clinical Quality Assurance to ensure compliance of internal SOPs
To perform this job successfully, an individual must be able to perform each essential duty effectively and efficiently. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Bachelor’s degree in health sciences or related field, advanced degree preferred
- Minimum of 10+ years of experience in clinical research with at least 7 years of experience in clinical study management across phases.
- Regulatory and compliance knowledge, including expert knowledge of ICH/GCP guidelines
- Experience with multi-center trials of investigational devices
- Experience with managing and demonstrating oversight of CROs, vendors, and consultants.
- Proven ability to build, manage and develop high performing teams; excellent delegation and conflict resolution skills
- Experience performing monitoring duties at sites preferred but not required
- Excellent organizational skills and attention to detail
- Proven ability to work independently and as part of a collaborative team
- Excellent interpersonal, oral and written communication skills
- Strong computer literacy and skills
- Fluent in English (oral and written)
- Moderate travel, up to 25% may be required
Gelesis is an EEO Employer
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