Vice President, Clinical Operations at Vedanta Biosciences

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Microbiome, Gastrointestinal DiseasesIndustries

Requirements

Deep expertise in the operational processes involved in clinical-stage drug development
Ability to thrive in a fast-paced environment with a well-honed, flexible, and adaptable mindset
Strong people management and mentoring skills, including team-building and developing high-caliber contributors
Experience working with a high level of independence and cross-functionally with executives and department leaders
Ability to effectively represent the company externally
Knowledge of Good Clinical Practice (GCP), ICH, and CFR guidelines

Responsibilities

Provide strategic and operational oversight of Vedanta's clinical trials to ensure they are completed on time, within budget, in accordance with GCP, and in compliance with relevant regulations
Develop and manage the Clinical Operations budget and resource forecast
Serve as a member of the corporate Operations Leadership Team
Provide strategic and tactical input into the planning and execution of clinical trials to meet development program goals
Develop, maintain, and manage relationships with CROs and other vendors to support clinical trials, ensuring deadlines and deliverables are met, risks are identified, and seamless integration
Lead future CRO selection processes as needed
Lead, manage, train, and develop the Clinical Operations team
Ensure Trial Master File (TMF)-related documentation is current, properly filed, and ready for audits or inspections
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, and scientific communication
Oversee and participate in the preparation of clinical study documents, including protocols, investigator brochures, informed consent forms, and clinical study reports

Skills

Clinical Operations

CRO Management

Clinical Trial Management

Budget Forecasting

Vendor Management

Phase 3 Trials

CGMP Manufacturing

Risk Management

People Management

Mentoring

Vedanta Biosciences

Develops microbiome-based therapies using bacteria

About Vedanta Biosciences

Vedanta Biosciences focuses on developing microbiome therapies using groups of beneficial bacteria known as bacterial consortia. These consortia can colonize the human intestine and have the potential to treat various diseases. The company utilizes a proprietary discovery platform to identify and assemble these bacteria into effective therapeutic teams. Unlike many competitors, Vedanta has achieved commercial-scale production of its drug candidates while adhering to strict FDA regulations for safety and quality. The goal of Vedanta Biosciences is to transform disease treatment by providing new options for patients through its innovative approach to drug discovery.

Cambridge, MassachusettsHeadquarters

2010Year Founded

$364.5MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Risks

Competition from Seres Therapeutics with FDA-approved C. difficile treatment.

High production costs may impact profitability and market reach.

Regulatory challenges due to unclear FDA guidelines for microbiome therapies.

Differentiation

Vedanta uses defined bacterial consortia for consistent therapeutic outcomes.

First to achieve commercial-scale CGMP production of bacterial consortia drugs.

Proprietary platform identifies and assembles optimal bacterial consortia for therapies.

Upsides

Fast Track designation for VE303 accelerates regulatory approval process.

Phase 3 RESTORATiVE303 study positions Vedanta as a market leader for rCDI.

Recent $106.5M funding round strengthens financial position and growth potential.

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