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:
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.
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.
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.
Vendor Management:
Select, manage, and collaborate with external vendors, including CROs and other service providers, to ensure seamless execution of clinical trials.
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.
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