Vice President Clinical Operations: Pharmacuticals

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

Job summary

An established industry player is seeking a Vice President of Clinical Operations to lead innovative gene therapy programs targeting cardiovascular diseases. This pivotal role involves overseeing clinical trial execution, ensuring adherence to regulatory standards, and collaborating with a multidisciplinary team. The ideal candidate will have extensive experience in clinical development and a strong background in gene therapy. This is an exciting opportunity to make a significant impact in advancing cutting-edge treatments while working in a dynamic and supportive environment.

Qualifications

• 10+ years of clinical development experience in biotechnology or pharmaceuticals.
• Strong knowledge of regulatory guidelines and clinical trial methodologies.

Responsibilities

• Lead strategic planning and execution of clinical trials for gene therapies.
• Oversee end-to-end execution of clinical trials ensuring compliance and safety.

Skills

Clinical Operations Leadership

Regulatory Compliance

Clinical Trial Execution

Cross-functional Collaboration

Budget Management

Gene Therapy Expertise

Education

MD or PhD in Life Sciences

Job description

Vice President Clinical Operations: Pharmacuticals

Vice President Clinical Operations: Pharmacuticals

Kelly Science, Engineering, Technology & Telecom provided pay range

This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$250,000.00/yr - $400,000.00/yr

Direct message the job poster from Kelly Science, Engineering, Technology & Telecom

Senior Recruiter at Kelly Science & Clinical | Clinical Research | Government Locum Tenens

Kelly Science & Clinical is seeking a Vice President of Clinical Operations for a fulltime, Direct Hire role with a pharmaceutical client based in the Boston area. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Location: Remote

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 2b/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

o Lead the strategic planning, design, and execution of clinical trials in the cardiac gene therapy programs.

o Provide expert clinical operations leadership, ensuring that clinical trial designs are scientifically sound, clinically relevant, and aligned with the overall product development strategy.

o Work closely with senior leadership, the CMO, and the CMC team to integrate clinical insights into product development decisions.

o 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

o Oversee the end-to-end execution of clinical trials, ensuring adherence to timelines, budgets, regulatory requirements, and safety standards.

o Drive the operational aspects of clinical trials, including site selection, CRO management, patient recruitment, and regulatory submissions.

o Ensure effective risk management processes are in place to identify, mitigate, and manage trial-related risks.

o Provide ongoing support for the clinical trial teams, ensuring that all aspects of trial conduct are compliant with GxP, ICH, and FDA/EMA regulations.

o Act as the clinical lead in interactions with regulatory agencies and external partners, ensuring regulatory compliance and successful trial approvals.

o Lead a high-performing clinical operations team focused on advancing gene therapy clinical programs in the cardiovascular space.

o Foster a culture of innovation, accountability, and collaboration within the clinical operations group.

o Provide leadership and development opportunities to junior staff and cross-functional team members.

4. Regulatory and Compliance

o Oversee the preparation and submission of clinical trial applications and ensure compliance with applicable regulations, including FDA, EMA, and other global regulatory bodies.

o Support interactions with regulatory agencies during preclinical, clinical, and post-market phases, ensuring the program stays aligned with regulatory expectations.

o Ensure robust pharmacovigilance practices are in place to monitor and manage the safety profile of gene therapies.

5. Cross-functional Collaboration

o Collaborate with Regulatory Affairs, Medical Affairs, and Commercial teams to ensure the alignment of clinical operations with overall corporate objectives.

o Work with the Business Development team to support licensing, partnerships, and collaborations, providing clinical insights and strategies.

o 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

o Manage the clinical operations budget and ensure cost-effective execution of clinical trials.

o Oversee resource allocation to ensure that clinical trials are adequately supported, both internally and through external partners.

7. Innovation & Scientific Expertise

o Stay at the forefront of scientific advancements in cardiac gene therapy and gene editing technologies.

o Advise on the development of cutting-edge clinical trial designs that optimize the delivery of gene therapies for heart diseases.

o 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.

· 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.

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.

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research and Science

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