VP Clinical Operations - Durham, United States - Life Science People

Description

Company Overview:

This company is a cutting-edge biotechnology company dedicated to advancing innovative solutions in healthcare. With a focus on research, development, and commercialization of groundbreaking therapies, we are at the forefront of transforming patient outcomes. Our commitment to scientific excellence and a patient-centric approach drives our pursuit of groundbreaking discoveries.

Position Overview:

We are seeking a dynamic and experienced Vice President of Clinical Operations to join our leadership team in Boston. The successful candidate will play a key role in overseeing and optimizing the clinical development process, ensuring the efficient execution of clinical trials, and contributing to the overall success of our programs.

Responsibilities:

1. Clinical Operations Leadership:

• Provide strategic leadership and direction to the Clinical Operations team, fostering a culture of excellence and collaboration.
• Oversee the planning, implementation, and management of clinical trials from Phase I to Phase III, ensuring adherence to timelines and budgets.

1. Strategic Planning and Execution:

• Collaborate with cross-functional teams to develop and implement clinical development plans aligned with corporate objectives.
• Drive the development and execution of clinical strategies, ensuring alignment with regulatory requirements.

1. Quality Assurance and Compliance:

• Establish and maintain high standards of quality and compliance within clinical operations, ensuring adherence to GCP, ICH, and other relevant guidelines.
• Implement and oversee quality management systems to proactively address potential issues.

1. Vendor Management:

• Select, manage, and collaborate with external vendors, including CROs and other service providers, to ensure seamless execution of clinical trials.
• Negotiate and manage contracts to optimize resources and deliverables.

1. Risk Management:

• Identify potential risks in clinical trial operations and develop strategies for risk mitigation.
• Provide timely and strategic solutions to address challenges that may impact the progress of clinical programs.

Qualifications:

• Advanced degree in life sciences or related field; MD, PhD, or equivalent preferred.
• Extensive experience (10+ years) in clinical operations within the biotechnology or pharmaceutical industry.
• Proven track record of successfully leading clinical development programs from Phase I through Phase III.
• Strong understanding of regulatory requirements and experience interacting with regulatory agencies.
• Excellent leadership and team management skills, with the ability to inspire and mentor a high-performing team.
• Demonstrated ability to collaborate effectively with cross-functional teams and external partners.
• Exceptional communication and presentation skills.