Associate Director, Clinical Operations

SUMMARY / JOB PURPOSE:

The Associate Director, Clinical Operations contributes to the development, strategic direction and implementation of multiple clinical trials. Responsibilities include providing oversight to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements, and leading and directing team members in the management of contract research organizations (CROs) and other trial vendors. This role provides Clinical Operations expertise in cross-functional meetings and initiatives. The Associate Director reports directly to the VP of Clinical Operations and may be responsible for the management of other Clinical Operations staff.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Accountable for overall management of multiple clinical trials including providing strategic direction to study teams to meet corporate study goals and timelines
• Contributes expertise in all operational activities pertaining to the execution of clinical trials
• Oversight of vendor budgets and contracts, in conjunction with the Contracts and Budget team, and reporting and justification of study metrics to executive management
• Partners with and maintains regular contact with relevant team members, such as Regulatory Affairs, Research & Development, Clinical Development, and others as needed
• Participates in the qualification and selection of CROs, clinical sites and vendors; coordinates requests for proposals (RFPs), reviews budgets and contributes to the decision-making process
• Attend CRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals
• Provides consistent, regular oversight of CRO and vendor performance
• In partnership with Clinical Operations senior management contributes to definition, development, and implementation of Clinical Operations functional initiatives for role clarity and institution of best practices
• Contributes to and engages Clinical Operations staff in process development, innovative problem solving, and training initiatives as needed
• Contributing member of various study and program teams; provides direction to lead CTMs in creating meeting agendas and documenting outcomes and deliverables
• Contributes to the development of staffing/resourcing plans
• Practices professionalism and integrity in all actions and in relationships with CyanVac/Blue Lake’s management, supervisors, team members, direct reports and vendors; exhibits and models leadership behavior through communication and appropriate temperament
• Ability to have difficult/crucial conversations with tact; demonstrated ability to foster and encourage concepts of teamwork, cooperation, self- mastery, and flexibility to get the work done; maintains composure under difficult circumstances

SUPERVISORY RESPONSIBILITIES:

• May directly supervise employee(s)

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

• Education/Experience:
• BA/BS in scientific or related field
• A minimum of 10 years of clinical trial experience
• A minimum of 5 years of study management
• Experience managing multiple CROs and vendors

Knowledge/Skills:

• Has extensive experience in relevant industry/profession
• Experience in all phases of clinical trials development, including international trials
• Demonstrated professional collaboration and leadership skills
• Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results in creative and effective ways
• Develops departmental processes and oversees and/or authorizes their implementation
• Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing
• Ability to handle multiple tasks with competing priorities
• A pro-active approach to problem solving
• Detailed knowledge of the clinical trials process and of the application of SOPs
• Detailed knowledge of GCP/ICH regulatory requirements
• Applies strong analytical and business communication skills
• Self-direction in work habits
• Ability to manage conflict in a direct and productive manner
• Ability to utilize a wide range of computer applications and tools (e.g., Microsoft Office Suite, SharePoint, Smartsheet, Veeva Vault, etc.)

JOB COMPLEXITY:

• Has an in-depth knowledge of Clinical Operations, business strategies and the company goals
• Excellent interpersonal, organizational, people management and project planning skills

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity or expression, marital status, pregnancy, citizenship, status as a veteran, and basis of disability or any other federal, state or local protected class.

Job Type: Full-time

Pay: $125,000.00 - $175,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Preferred)

Experience:

• clinical trial: 10 years (Required)

Work Location: Hybrid remote in Los Gatos, CA 95032

Salary : $125,000 - $175,000