Vice President, Clinical Operations

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 potential first-in-class oral therapy VE303 in a Phase 3 trial for recurrent C. difficile infection. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.

The Role:

The Vice President, Clinical Operations has deep expertise in the operational processes involved in clinical-stage drug development. This leader is responsible for managing the people and activities of Clinical Operations, including the planning, execution, and management of Vedanta's global clinical program(s). Responsibilities include oversight of Clinical Operations budgets and timelines, including planning and forecasting. Additionally, this individual will own the relationship between Vedanta and contracted research organizations (CROs) and other vendors working on Vedanta's clinical programs. Specifically, they will ensure CRO deadlines and deliverables are met, risks are proactively identified, and the CRO and Vedanta are seamlessly integrated. This individual will lead future CRO selection processes as needed.

The Vice President, Clinical Operations will prioritize and embrace their role as people manager and mentor. They will guide and lead the development, training, resourcing, and management of the Clinical Operations team. They must be an adept team-builder, able to identify and grow high-caliber contributors.

The person in this role must thrive in a fast-paced environment and bring a well-honed, flexible, and adaptable mindset. This individual will serve in a leadership position, working with a high level of independence and cross-functionally with executives and other department leaders. In addition to these internal-facing responsibilities, the Vice President, Clinical Operations must be able to effectively represent the company externally.

Here’s What You’ll Do:

• Provide strategic and operational oversight of Vedanta's clinical trials to ensure they are completed on time, within budget, in accordance with Good Clinical Practice (GCP), and in compliance with all relevant regulations, including ICH and CFR guidelines
• Develop and manage the Clinical Operations budget and resource forecast
• Serve as a member of the corporate Operations Leadership Team
• Ensure that goals and objectives of the 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
• Work with team members to ensure that Trial Master File (TMF)-related documentation is current, filed at the appropriate locations, and ready in a timely manner for TMF audits or inspections
• Lead, manage, train, and develop the Clinical Operations team to function effectively and cohesively
• Partner with CMC and Clinical Supply teams to ensure adequate and timely clinical supply to clinical sites
• Collaborate with Medical Affairs to align on clinical study design, data dissemination strategies, and scientific communication initiatives
• Oversee and participate in the preparation of clinical study documents including protocols, investigator brochures, informed consent forms, and clinical study reports; plan and execute investigator meetings
• Develop and report key executional metrics for the oversight of clinical trials
• In collaboration with Clinical Quality Assurance, develop and revise (as needed) corporate and functional area policies, standard operating procedures, work instructions, and other job aids

Requirements:

• BS, RN, MS degree or higher, plus at least 15 years of experience in the pharmaceutical industry with at least 10 years of Clinical Research or Clinical Operations leadership experience
• Extensive knowledge of GCPs governing the conduct of clinical trials; working knowledge of FDA, EMA, and ICH guidelines
• In-depth experience in selecting CROs and key vendors, negotiating key terms, and managing these relationships
• Deep drug development experience, with a track record of success in the execution of clinical trials in Phases 1-3
• Experience in developing SOPs, risk mitigation plans, and clinical operations metrics
• Strong leadership skills in a matrix environment; demonstrated ability to lead, manage performance, mentor, and build clinical operations teams
• Must be self-motivated, highly organized, detail-oriented, and able to multi-task while delivering high-quality work
• Excellent oral and written communication skills
• If not local, ability to travel to the office in Cambridge approximately once monthly for onsite meetings, coordination, and team-building
• Willingness and ability to travel occasionally (anticipated <10% of work time), domestically and internationally