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:
2. Provide strategic leadership and direction to the Clinical Operations team, fostering a culture of excellence and collaboration.
3. Oversee the planning, implementation, and management of clinical trials from Phase I to Phase III, ensuring adherence to timelines and budgets.
4. Strategic Planning and Execution:
5. Collaborate with cross-functional teams to develop and implement clinical development plans aligned with corporate objectives.
6. Drive the development and execution of clinical strategies, ensuring alignment with regulatory requirements.
7. Quality Assurance and Compliance:
8. Establish and maintain high standards of quality and compliance within clinical operations, ensuring adherence to GCP, ICH, and other relevant guidelines.
9. Implement and oversee quality management systems to proactively address potential issues.
10. Vendor Management:
11. Select, manage, and collaborate with external vendors, including CROs and other service providers, to ensure seamless execution of clinical trials.
12. Negotiate and manage contracts to optimize resources and deliverables.
13. Risk Management:
14. Identify potential risks in clinical trial operations and develop strategies for risk mitigation.
15. 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.