Vice President of Clinical Operations

Kelly Science, Engineering, Technology & Telecom; United States; Remote; USD 250,000 - 400,000; Full time

Job summary

An innovative firm is seeking a visionary leader for the role of Vice President of Clinical Operations. This remote opportunity involves shaping the future of gene therapy for cardiovascular diseases, guiding multidisciplinary teams through the complexities of clinical trial execution, and ensuring compliance with regulatory standards. The ideal candidate will have a strong background in clinical development, particularly in gene therapy, and a passion for fostering collaboration and innovation. Join a forward-thinking organization that values scientific integrity and aims to make a significant impact in the medical field.

Benefits

Medical Insurance

Vision Insurance

401(k)

Qualifications

• 10+ years of clinical development experience in biotechnology or pharmaceuticals.
• Extensive experience leading clinical trials, especially in gene therapy.

Responsibilities

• Drive strategic planning and execution of cardiac gene therapy clinical trials.
• Lead end-to-end clinical trial execution, ensuring adherence to timelines and standards.

Skills

Clinical Development

Gene Therapy

Regulatory Compliance

Team Leadership

Strategic Planning

Education

MD, PhD or equivalent in life sciences

Tools

Clinical Trial Management Systems

Data Management Software

Job description

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Kelly Science & Clinical is seeking a Vice President of Clinical Operations for a growing client. This is a Remote opportunity.

Location: Remote

Salary: Commensurate with experience and location is also taken into consideration

Employment Type: Full Time; Direct Hire

Summary:

As the Vice President (VP) of Clinical Operations, you'll play a pivotal role in shaping the future of gene therapy for cardiovascular diseases. As a visionary leader, you'll spearhead the clinical development strategy, ensuring seamless execution of Phase 1 to 3 clinical trials with the utmost scientific, regulatory, and ethical integrity. Your leadership will guide a multidisciplinary team and foster collaboration with key stakeholders, including regulatory authorities, clinical research organizations (CROs), academic institutions, and contract research providers.

Job duties include:

• Drive strategic planning and execution of cardiac gene therapy clinical trials, ensuring alignment with product development strategies.
• Collaborate with senior leadership and teams to incorporate clinical insights into product decisions.
• Develop and implement clinical operations strategies focusing on timely delivery, budget management, and data quality.
• Lead end-to-end clinical trial execution, ensuring adherence to timelines, budgets, regulatory standards, and safety protocols.
• Oversee site selection, CRO management, patient recruitment, and regulatory submissions.
• Implement effective risk management processes for trial-related challenges.
• Ensure trial compliance with GxP, ICH, FDA, and EMA regulations, providing support to clinical teams.
• Act as a liaison with regulatory agencies and external partners, ensuring successful trial approvals.
• Lead and develop a high-performing clinical operations team in cardiovascular gene therapy.
• Promote a culture of innovation, accountability, and collaboration.
• Support professional growth through development opportunities for junior and cross-functional team members.
• Manage clinical trial applications and compliance with global regulations, including FDA and EMA.
• Ensure robust pharmacovigilance practices for safety in gene therapy programs.
• Engage with regulatory agencies throughout preclinical, clinical, and post-market phases.
• Align clinical operations with corporate objectives through collaboration with Regulatory Affairs, Medical, and Commercial teams.
• Support licensing and partnerships, providing clinical insights and strategies.
• Maintain effective communication with external partners, CROs, clinical sites, and academics to ensure program success.
• Oversee clinical operations budget and ensure efficient trial execution.
• Allocate resources effectively, ensuring trials receive adequate support from internal and external partners.
• Stay updated on scientific advances in cardiac gene therapy and gene editing.
• Advise on innovative clinical trial designs for optimal gene therapy delivery.
• Contribute to the scientific and clinical strategy in cardiovascular gene therapy.

Qualifications:

• 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.

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.

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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