Vedanta Biosciences, Inc.
Vice President, Clinical Operations
Vedanta Biosciences, Inc., Cambridge, Massachusetts, us, 02140
Title
Vice President, Clinical Operations Location
Cambridge, MA OR Hybrid Reports to
Chief Medical Officer About Vedanta Biosciences
Vedanta Biosciences is a late‑stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include a potential first‑in‑class oral therapy, VE303, in a Phase 3 trial for recurrent C. difficile infection. Vedanta’s pipeline is built on a unique product engine that utilizes large libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary consortium design capabilities, and end‑to‑end CGMP manufacturing at commercial launch scale. The Role
The Vice President, Clinical Operations will manage the people and activities of Vedanta’s global clinical program(s). Responsibilities include oversight of Clinical Operations budgets and timelines, management of relations with contracted research organizations (CROs) and vendors, ensuring CRO deadlines and deliverables are met, and leading future CRO selection processes. The role requires strong people‑management skills, the ability to mentor and develop the Clinical Operations team, and a flexible, adaptable mindset suitable for a fast‑paced environment. The position is an executive leadership role with significant cross‑functional influence and external representation of the company. Responsibilities
Provide strategic and operational oversight of clinical trials to ensure they are completed on time, within budget, in accordance with Good Clinical Practice (GCP) and regulatory guidelines. Develop and manage the Clinical Operations budget and resource forecast. Serve as a member of the corporate Operations Leadership Team. Ensure goals and objectives of development programs are met by providing strategic and tactical input into the planning and execution of clinical trials. Develop, maintain, and manage relationships with CROs and other vendors to support clinical trials. Ensure Trial Master File (TMF)-related documentation is current and ready for audits or inspections. Lead, manage, train, and develop the Clinical Operations team. Partner with CMC and Clinical Supply teams to ensure adequate and timely clinical supply to sites. Collaborate with Medical Affairs on clinical study design, data dissemination strategies, and scientific communication. Oversee preparation of clinical study documents (protocols, investigator brochures, informed consent forms, study reports) and conduct investigator meetings. Develop and report key execution metrics for clinical trial oversight. Work with Clinical Quality Assurance to develop and revise corporate and functional area policies, SOPs, work instructions, and other job aids. Qualifications
BS, RN, MS or equivalent degree plus at least 15 years in the pharmaceutical industry. At least 10 years of Clinical Research or Clinical Operations leadership experience. Extensive knowledge of GCP, FDA, EMA, and ICH regulatory frameworks. In‑depth experience selecting and managing CROs and key vendors. Successful track record of executing Phase 1‑3 clinical trials. Experience developing SOPs, risk mitigation plans, and clinical operations metrics. Strong leadership skills in a matrix environment with proven ability to mentor and build teams. Highly organized, detail‑oriented, self‑motivated, and capable of multi‑tasking. Excellent oral and written communication. Ability to travel to Cambridge office approximately once monthly and occasional international travel (
Compensation
Base pay range: $275,000 – $330,000 annually (variable based on market dynamics, experience, and internal equity). Total compensation also includes stock options, a target annual bonus, and standard benefits. EEO Statement
Vedanta is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any other characteristic protected by law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Vaccination Requirement
All employees must be fully vaccinated against COVID‑19. Newly hired employees must be fully vaccinated prior to their employment start date. Vedanta will consider accommodations for individuals unable to be vaccinated due to a qualifying medical condition, disability, or sincerely held religious objection.
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Vice President, Clinical Operations Location
Cambridge, MA OR Hybrid Reports to
Chief Medical Officer About Vedanta Biosciences
Vedanta Biosciences is a late‑stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include a potential first‑in‑class oral therapy, VE303, in a Phase 3 trial for recurrent C. difficile infection. Vedanta’s pipeline is built on a unique product engine that utilizes large libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary consortium design capabilities, and end‑to‑end CGMP manufacturing at commercial launch scale. The Role
The Vice President, Clinical Operations will manage the people and activities of Vedanta’s global clinical program(s). Responsibilities include oversight of Clinical Operations budgets and timelines, management of relations with contracted research organizations (CROs) and vendors, ensuring CRO deadlines and deliverables are met, and leading future CRO selection processes. The role requires strong people‑management skills, the ability to mentor and develop the Clinical Operations team, and a flexible, adaptable mindset suitable for a fast‑paced environment. The position is an executive leadership role with significant cross‑functional influence and external representation of the company. Responsibilities
Provide strategic and operational oversight of clinical trials to ensure they are completed on time, within budget, in accordance with Good Clinical Practice (GCP) and regulatory guidelines. Develop and manage the Clinical Operations budget and resource forecast. Serve as a member of the corporate Operations Leadership Team. Ensure goals and objectives of development programs are met by providing strategic and tactical input into the planning and execution of clinical trials. Develop, maintain, and manage relationships with CROs and other vendors to support clinical trials. Ensure Trial Master File (TMF)-related documentation is current and ready for audits or inspections. Lead, manage, train, and develop the Clinical Operations team. Partner with CMC and Clinical Supply teams to ensure adequate and timely clinical supply to sites. Collaborate with Medical Affairs on clinical study design, data dissemination strategies, and scientific communication. Oversee preparation of clinical study documents (protocols, investigator brochures, informed consent forms, study reports) and conduct investigator meetings. Develop and report key execution metrics for clinical trial oversight. Work with Clinical Quality Assurance to develop and revise corporate and functional area policies, SOPs, work instructions, and other job aids. Qualifications
BS, RN, MS or equivalent degree plus at least 15 years in the pharmaceutical industry. At least 10 years of Clinical Research or Clinical Operations leadership experience. Extensive knowledge of GCP, FDA, EMA, and ICH regulatory frameworks. In‑depth experience selecting and managing CROs and key vendors. Successful track record of executing Phase 1‑3 clinical trials. Experience developing SOPs, risk mitigation plans, and clinical operations metrics. Strong leadership skills in a matrix environment with proven ability to mentor and build teams. Highly organized, detail‑oriented, self‑motivated, and capable of multi‑tasking. Excellent oral and written communication. Ability to travel to Cambridge office approximately once monthly and occasional international travel (
Compensation
Base pay range: $275,000 – $330,000 annually (variable based on market dynamics, experience, and internal equity). Total compensation also includes stock options, a target annual bonus, and standard benefits. EEO Statement
Vedanta is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any other characteristic protected by law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Vaccination Requirement
All employees must be fully vaccinated against COVID‑19. Newly hired employees must be fully vaccinated prior to their employment start date. Vedanta will consider accommodations for individuals unable to be vaccinated due to a qualifying medical condition, disability, or sincerely held religious objection.
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