Clinical Operations Program Lead

Title:                   Clinical Operations Program Lead

Location:           Cambridge, MA, Hybrid, or Remote

Reports to:        VP, Clinical Operations

The Role:

The Clinical Operations Program Lead (COPL) will be responsible for at least one of Vedanta’s later-stage clinical programs. The ideal candidate will represent the Clinical Operations group at cross-functional Program Team Meetings (PTMs) and ensure that information regarding their assigned program is appropriately shared and actionable by the program team. In addition, the COPL will formally serve as a people manager for some Clinical Operations personnel and informally mentor other individuals and functions to ensure their correct understanding of what needs to be done concerning the program. The successful candidate should be proactive, flexible, collaborative, and above all else, driven to bring Vedanta’s clinical programs in on time and on budget.

Here’s What You’ll Do:

• Take overall accountability for the operational delivery of the clinical studies within a Program and provides appropriate oversight to ensure a high quality, ethical, cost-efficient way to meet timelines and patient recruitment goals.
• Actively participate in the Program team and other applicable sub-team meetings, collaborates and integrates with other functions within Research, CMC, Clinical Supply, Regulatory Affairs, etc., to bring the program forward.
• Lead the development and ongoing refinement of Program level study timelines and scenarios
• Provide rigorous, objective information (operational status and updates) to the Program team and, as necessary, Vedanta senior leadership to help support strategic program decisions.
• Work collaboratively with and mentor, as appropriate, other clinical operations professionals and supportive roles within the Program (clinical trial coordinators, quality representatives, vendor managers, etc.)
• Partner with the Head of Clinical Operations, own the accountability of overseeing and driving CRO and other vendor relationships to ensure execution of clinical studies within the Program and consistent with articulated timelines, budget, etc.
• Participate in departmental and cross-functional risk assessment, technology development, and process improvement initiatives, including SOP development, review, and maintenance.
• Participate/lead in site engagement programs to help build relationships with key opinion leaders, investigators, and clinical site staff to support the clinical study activities and delivery
• Create and implement risk assessment and mitigation plans, performing regular reviews to continually assess for changes.
• Provide management, training, oversight, coaching, mentoring, and development to one or more direct reports.

Requirements:

• BA/BS degree required in science/health-related field. 10+ years of clinical research and management experience in biotech, pharmaceutical, or relevant CRO experience.
• Highly advanced knowledge of the clinical development process and well-versed in GCP and applicable Federal and International regulations required
• Over ten years of experience in clinical trial management – experience that spans small Phase 1 studies to large multi-center global trial programs
• Demonstration of project/program management skills, including risk assessment, timeline and budget management, and contingency planning
• Experienced in identifying and leveraging relevant data and information to develop well-conceived and executable timelines.
• Independently motivated, detail-oriented, and good problem-solving ability (think outside of the box mentality)
• Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment.

Why join Vedanta Biosciences:

Vedanta is pioneering the development of a new class of therapies that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology. 

We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.

Our Vision:

We are harnessing the human microbiome to enable a new drug modality based on rationally defined bacterial consortia

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.

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