Head of Clinical Operations - San Diego, United States - Candid Therapeutics
3 weeks ago
Description
Company Overview:
Candid Therapeutics is a growing biotechnology company based in San Diego, California, dedicated to improving patients' lives by advancing novel therapies to address unmet medical needs.
Position Overview:
As the Head of Clinical Operations, you will be a key leader in the company, responsible for overseeing all aspects of clinical trial operations from planning through execution to ensure the successful conduct of clinical programs.
You will play a critical role in driving the development and implementation of clinical strategies, optimizing operational efficiencies, and ensuring compliance with regulatory requirements and industry standards.
Key Responsibilities:
Clinical Trial Strategy and Planning:
- Develop and implement comprehensive clinical trial strategies aligned with the company's overall objectives and therapeutic area priorities.
- Lead the development of clinical trial protocols, study budgets, timelines, and resource plans in collaboration with crossfunctional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs.
- Provide strategic input and operational expertise to support the selection of clinical trial sites, investigators, and vendors.
Clinical Trial Execution:
- Oversee the execution of clinical trials according to protocol, regulatory requirements, Good Clinical Practice (GCP) guidelines, and company SOPs.
- Manage clinical trial timelines, budgets, and resources to ensure efficient and costeffective conduct of studies while maintaining quality and compliance.
- Monitor study progress, patient enrollment, and data quality, and implement corrective actions as needed to address issues and mitigate risks.
Vendor Management and Outsourcing:
- Select, onboard, and manage clinical research organizations (CROs), central laboratories, and other vendors to support clinical trial activities.
- Negotiate contracts, oversee performance, and ensure adherence to quality standards, timelines, and budgetary constraints.
- Establish effective communication and collaboration with vendors to optimize operational efficiencies and achieve study goals.
Clinical Operations Oversight:
- Lead and mentor a team of clinical operations professionals, providing guidance, support, and professional development opportunities.
- Implement and maintain clinical operations policies, procedures, and systems to ensure compliance with regulatory requirements and industry best practices.
- Foster a culture of collaboration, innovation, and continuous improvement within the clinical operations team and across crossfunctional stakeholders.
Qualifications:
- Advanced degree (MD, PhD, or equivalent) in a relevant scientific or healthcare discipline is highly desirable.
- Extensive experience (15+ years) in clinical operations management within the biotechnology or pharmaceutical industry, with a proven track record of successful clinical trial execution and program management.
- Strong leadership and management skills, with the ability to build and lead highperforming teams in a fastpaced and dynamic environment.
- Indepth knowledge of clinical trial conduct, regulatory requirements, and GCP guidelines, with experience in multiple phases of clinical development and a variety of therapeutic areas.
- Excellent communication, negotiation, and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.
- Demonstrated ability to think strategically, solve complex problems, and make datadriven decisions to drive clinical trial success.
How to Apply:
Pay:
$250, $350,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Experience level:
- 10 years
Experience:
- FDA regulations: 1 year (preferred)
Ability to Commute:
- San Diego, CA (required)
Ability to Relocate:
- San Diego, CA: Relocate before starting work (preferred)
Work Location:
In person
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