Job Description

Title: Director / Senior Director Clinical Programs

C ompany: Confidential Health-Tech Innovator

Location: San Francisco Bay Area, California

About Our Client:

Our client is a leading-edge health-tech company at the forefront of innovative clinical access programs. A relatively recent creation, their mission is to bridge the gap between promising investigational treatments and patients with serious conditions who cannot enroll in traditional clinical trials.

Overview:

Our client is seeking a seasoned and energetic Director/Senior Director of Clinical Programs to join its expanding team on our behalf. The ideal candidate will have a solid foundation in the administration of clinical research operations, preferably within a CRO environment. This individual will be responsible for and play a crucial role in leading an expanding portfolio of specialized clinical access programs.

Responsibilities:

Ensure the planning, implementation, and management of various clinical access programs across various therapeutic areas. Develop and maintain SOPs for program operations. Liaise with pharmaceutical partners in the design and execution of programs to align with their strategies in clinical development. Oversee the development of study protocols, informed consent forms, and other essential documents. Manage clinical sites, investigators, and other stakeholder relationships.

Ensure adherence to regulatory requirements, including FDA regulations and ICH-GCP guidelines. Lead and mentor clinical project teams. Monitor program timelines, budgets, and resources to ensure effective execution. Analyze and report program metrics and outcomes. Contribute to business development by participating in client meetings and proposal development.

Requirements

Qualifications

• Advanced degree in life sciences, healthcare, or related field; MD, PhD, PharmD preferred
• Minimum of 10 years relevant experience in clinical research with a minimum of 5 years leadership-level experience
• Deep understanding of the processes for planning, executing, and managing clinical trials, FDA regulations, and ICH-GCP guidelines
• Strong knowledge of special access programs and applicable regulations
• Proven expertise in the delivery and management of complicated clinical programs
• Excellent project management and organizational skills
• Excellent communication and interpersonal skills
• Prior work experience with CRO's or smaller pharma/ biotechs
• Familiarity with clinical trial management systems and other relevant software

Preferred Qualifications

• Direct experience with expanded access or other pre-approval access mechanisms
• Neurology, oncology, rare disease, or other relevant therapeutic area background
• Experience with real-world data collection and analysis Knowledge of cost recovery models in clinical research

Benefits

Our client is offering:

• Salary up to $240,000 plus equity as well as a comprehensive benefits package
• Opportunity to make material difference in the lives of patients
• Fast-paced dynamic and innovative work environment
• Opportunities for Professional Growth and Development
• Flexible Work Arrangements around San Fran busy traffic periods

Work Location and Schedule:

This role will require 3-4 days of in-office presence per week in San Jose, CA

How To Apply:

If you are a qualified candidate looking for this exciting opportunity, please submit your resume and cover letter with relevant experience to the contact information noted below. All applications will be received in strict confidence.

Our client is an equal opportunities employer and embraces applications from all qualified individuals. They invite applications without regard to race, color, religious affiliation, gender, sexual orientation, gender identity or expression, age, nationality, marital status, ability, or veteran status.

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