Head of clinical operations

Full job 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 cross-functional 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 cost-effective 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 cross-functional 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 high-performing teams in a fast-paced and dynamic environment.

· In-depth 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 data-driven decisions to drive clinical trial success.

How to Apply:

To apply, please submit your resume to

Candid Therapeutics is an equal opportunity employer and is committed to diversity in the workplace. We encourage applications from all qualified individuals, regardless of race, ethnicity, gender, sexual orientation, age, disability, or veteran status.

Job Type: Full-time

Pay: $250,000.00 - $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