Vice President of Clinical Operations Job Listing at Kelly Services in Boston, MA (Job ID US3555960_BH9802576)

Description

Vice President of Clinical Operations

Kelly® Science & Clinical is seeking an experienced Vice President of Clinical Operations for a full-time, Direct Hire opportunity with our clinical-stage biopharmaceutical client. The experience we are looking for will have a mix of clinical development as well as strong clinical operations experience leading complex clinical studies from start to finish.
 
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• Location: Remote
• Job Opportunity: Direct Hire
• Salary: The salary for this position is competitive and will be commensurate with the candidate's experience and geographic location within the United States. We recognize that compensation may vary based on local market conditions and individual qualifications.

Position Overview
The Vice President (VP) of Clinical Operations will be responsible for executing the clinical development strategy for our client's innovative gene therapies targeting cardiovascular diseases. This individual will be responsible for overseeing the clinical operations and execution of Phase 1 to 3 clinical trials, ensuring that all studies are designed and conducted to the highest scientific, regulatory, and ethical standards. The VP will lead a multidisciplinary team and collaborate closely with internal and external stakeholders, including regulatory authorities, clinical research organizations (CROs), academic institutions, and contract research providers.

Key Responsibilities

1. Clinical Strategy & Leadership

• Lead the strategic planning, design, and execution of clinical trials in the cardiac gene therapy programs.
• Provide expert clinical operations leadership, ensuring that clinical trial designs are scientifically sound, clinically relevant, and aligned with the overall product development strategy.
• Work closely with senior leadership, the CMO, and the CMC team to integrate clinical insights into product development decisions.
• Develop and implement robust clinical operations strategies, with a focus on timely execution, budget management, and high-quality clinical data generation.

2. Clinical Trial Execution

• Oversee the end-to-end execution of clinical trials, ensuring adherence to timelines, budgets, regulatory requirements, and safety standards.
• Drive the operational aspects of clinical trials, including site selection, CRO management, patient recruitment, and regulatory submissions.
• Ensure effective risk management processes are in place to identify, mitigate, and manage trial-related risks.
• Provide ongoing support for the clinical trial teams, ensuring that all aspects of trial conduct are compliant with GxP, ICH, and FDA/EMA regulations.
• Act as the clinical lead in interactions with regulatory agencies and external partners, ensuring regulatory compliance and successful trial approvals.

3. Team Leadership & Development

• Lead a high-performing clinical operations team focused on advancing gene therapy clinical programs in the cardiovascular space.
• Foster a culture of innovation, accountability, and collaboration within the clinical operations group.
• Provide leadership and development opportunities to junior staff and cross-functional team members.

4. Regulatory and Compliance

• Oversee the preparation and submission of clinical trial applications and ensure compliance with applicable regulations, including FDA, EMA, and other global regulatory bodies.
• Support interactions with regulatory agencies during preclinical, clinical, and post-market phases, ensuring the program stays aligned with regulatory expectations.
• Ensure robust pharmacovigilance practices are in place to monitor and manage the safety profile of gene therapies.

5. Cross-functional Collaboration

• Collaborate with Regulatory Affairs, Medical Affairs, and Commercial teams to ensure the alignment of clinical operations with overall corporate objectives.
• Work with the Business Development team to support licensing, partnerships, and collaborations, providing clinical insights and strategies.
• Establish effective communication with external partners, CROs, clinical sites, and academic institutions to ensure the successful implementation of clinical programs.

6. Budget and Resource Management

• Manage the clinical operations budget and ensure cost-effective execution of clinical trials.
• Oversee resource allocation to ensure that clinical trials are adequately supported, both internally and through external partners.

7. Innovation & Scientific Expertise

• Stay at the forefront of scientific advancements in cardiac gene therapy and gene editing technologies.
• Advise on the development of cutting-edge clinical trial designs that optimize the delivery of gene therapies for heart diseases.
• Contribute to the company's overall scientific and clinical strategy, particularly in the context of gene therapy in cardiovascular medicine.

Qualifications

Education & Experience

• MD, PhD, or equivalent in a relevant life sciences or medical field preferred.
• Minimum of 10+ years of clinical development experience in the biotechnology or pharmaceutical industry, with at least 5 years in clinical operations leadership at Sr Director or VP level.
• Extensive experience leading clinical trials, ideally in gene therapy, gene editing, or cell therapy, with a focus on cardiovascular diseases. Heart failure experience preferred.
• Strong knowledge of regulatory guidelines (FDA, EMA, ICH, GxP) and clinical trial methodologies.

Skills & Competencies

• Proven experience in the strategic and operational leadership of complex clinical trials.
• Strong understanding of cardiovascular gene therapy and related therapeutic areas.
• Demonstrated success in managing cross-functional teams, external partnerships, and stakeholders.
• Excellent communication, presentation, and negotiation skills.
• Ability to manage multiple priorities and complex projects in a fast-paced, dynamic environment.
• Experience managing large-scale budgets.

Preferred Qualifications

• Experience in leading or overseeing cardiac clinical trials, particularly gene therapies or regenerative medicine.
• Expertise in developing and executing innovative clinical trial designs and patient-centric approaches.
• Experience with global clinical trials and working in diverse international regulatory environments.
• Advanced knowledge of clinical data management, statistical analysis, and clinical trial reporting.

Personal Characteristics

• Strategic thinker, with the ability to translate complex scientific concepts into actionable clinical strategies.
• Collaborative leader who thrives in a fast-paced, results-oriented environment.
• Strong commitment to improving patient outcomes and advancing the science of gene therapy.
• Excellent problem-solving skills and a passion for pioneering innovative treatments for cardiovascular diseases.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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